Archive for May, 2015

(PPHM) Enters Into Immunotherapy Research Collaboration

Research Collaboration to Focus on Exploring Potential Combinations of PS-Targeting Agents Including Bavituximab With Other Immune Modulators

TUSTIN, Calif., May 29, 2015  — Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development for the treatment of lung cancer, today announced that the company has entered into a sponsored research agreement with Memorial Sloan Kettering Cancer Center (MSK) to explore the potential of Peregrine’s proprietary phosphatidylserine (PS)-targeting antibody platform. The goal of the research is to identify effective treatment combinations based on Peregrine’s PS-targeting agents, including Peregrine’s lead clinical agent bavituximab, with other checkpoint inhibitors or immune stimulating agents that will further guide the bavituximab clinical development program.

The studies at MSK will be performed under the direction of Taha Merghoub, Ph.D., Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, M.D., Ph.D., a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.

“The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system’s response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy,” said Dr. Wolchok.

As part of the collaboration, researchers at MSK will conduct research to further explore the combination of PS-targeting agents, including bavituximab, that block a primary immunosuppressive pathway thereby allowing anti-tumor immune responses with other immuno-stimulatory agents that enhance immune responses. Specifically, MSK researchers will examine the combination of bavituximab alongside models of checkpoint blockade that are unresponsive to inhibition or co-stimulation given the ability of bavituximab to reprogram myeloid derived suppressor cells (MDSC) and increase tumoricidal T-cells in tumors, a mechanism of action that is complementary to checkpoint blockade and T-cell activation.

“A key focus of the Wolchok Lab’s research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab,” said Dr. Merghoub.

“We are delighted to be working with a world-renowned pioneer and leader in the immuno-oncology space, recognizing that there remains significant research in order for more cancer patients to realize the benefits of combination immune therapy,” said Jeff T. Hutchins, Ph.D., VP of Preclinical Research at Peregrine. “Our internal and collaborative research presented over the last year has established a robust foundation of PS-targeting activity on which to initiate this next chapter in PS research and development.”

“This collaboration is an important extension of our established research efforts to further explore and understand the potential of our PS-targeting platform including bavituximab our lead clinical candidate. This research will focus on better understanding how treatment with PS-targeting agents can assist other anti-tumor immunotherapies in order to work better,” said Steven King, chief executive officer of Peregrine. “Our goal is to change the way cancer patients are treated by allowing their immune system to recognize and fight their disease. This collaboration will undoubtedly assist us in identifying potential new opportunities to better treat patients with cancer.”

Peregrine’s antibodies target and bind to phosphatidylserine (PS), a highly immunosuppressive molecule normally located on the interior of cellular membranes, but, following stresses in the tumor environment, becomes exposed on tumor cells and cells that line tumor blood vessels, helping tumors to evade immune detection. PS-targeting antibodies block this immunosuppressive signal, thereby enabling the immune system to better recognize and fight the tumor. Preclinical data show that the combination of bavituximab and inhibitors of immune checkpoints reduce tumor-suppressive factors including myeloid-derived suppressor cells and confer increased tumor-specific immunity when compared to either treatment alone.

About Peregrine Pharmaceuticals, Inc.

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company’s lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the “SUNRISE trial”) along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit www.peregrineinc.com.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the sponsored research does not establish that the company’s PS-targeting platform improves the efficacy of other immune modulatory agents. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2014 as well as any updates to these risk factors filed from time to time in the company’s other filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

CONTACT: Christopher Keenan
         Peregrine Pharmaceuticals, Inc.
         (800) 987-8256
         info@peregrineinc.com
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(PSIX) to Present at Upcoming Investor Conferences

WOOD DALE, Ill., May 29, 2015  — Power Solutions International, Inc. (Nasdaq:PSIX), a leader in the design, engineering and manufacture of emissions-certified, alternative-fuel and conventional power systems, today announced that the Company will present at the following investor conferences during the month of June:

  • On Wednesday, June 3, 2015, PSI Chief Financial Officer Daniel Gorey will host investor meetings at the Avondale Partners Industrials 1-1 Conference, to be held at The Millennium Broadway Hotel in New York City, NY. Attendance at the conference is by invitation only for clients of Avondale Partners. Please contact your Avondale representative for conference registration information and to schedule a meeting with the Company.
  • On Wednesday, June 10, 2015, Mr. Gorey will host investor meetings at the ROTH Capital Partners New York Corporate Access Day, to be held at The Waldorf Astoria Hotel in New York City, NY. Attendance at the conference is by invitation only for clients of ROTH Capital Partners. Please contact your ROTH representative for conference registration information and to schedule a meeting with the Company.
  • On Tuesday, June 16, 2015, at 9:10 AM ET, PSI Chief Operating Officer Eric Cohen and Mr. Gorey will present at the Stifel Nicolaus Industrials Conference 2015, to be held at The New York Palace Hotel in New York City, NY. Attendance at the conference is by invitation only for clients of Stifel, but a simultaneous live webcast of the presentation will be available on the Investor Relations section of the Company’s website at www.psiengines.com. The webcast will be archived on the Company’s website for 90 days. The Company will also host investor meetings throughout the day at the conference. Please contact your Stifel representative for conference registration information and to schedule a meeting with the Company.
  • On Tuesday, June 23, 2015, at 11:00 AM CT, Mr. Gorey will present at the Global Hunter Securities GHS 100 Energy Conference, to be held at The JW Marriott Hotel in Chicago, IL. Attendance at the conference is by invitation only for clients of Global Hunter, but a simultaneous live webcast of the presentation will be available on the Investor Relations section of the Company’s website at www.psiengines.com. The webcast will be archived on the Company’s website for 90 days. The Company will also host investor meetings throughout the day at the conference. Please contact your GHS representative for conference registration information and to schedule a meeting with the Company.

About Power Solutions International, Inc.

Power Solutions International, Inc. (PSI) is a leader in the design, engineering and manufacture of emissions-certified, alternative-fuel power systems. PSI provides integrated turnkey solutions to leading global original equipment manufacturers in the industrial and on-road markets. The Company’s unique in-house design, prototyping, engineering and testing capacities allows PSI to customize clean, high-performance engines that run on a wide variety of fuels, including natural gas, propane, biogas, diesel and gasoline.

PSI develops and delivers complete .97 to 22 liter power systems, including the 8.8 liter engine aimed at the industrial and on-road markets, such as medium duty fleets, delivery trucks, school buses and garbage/refuse trucks. PSI power systems are currently used worldwide in power generators, forklifts, aerial lifts, and industrial sweepers, as well as in oil and gas, aircraft ground support, agricultural and construction equipment.

Acquired in April 2014, Professional Power Products (3PI) is a leading designer and manufacturer of large, custom engineered integrated electrical power generation systems serving the global diesel and natural gas power generation market. 3PI specializes in power generation systems for both standby and prime power applications.

CONTACT: Power Solutions International, Inc.
         Daniel P. Gorey
         Chief Financial Officer
         +1 (630) 451-2290
         dan.gorey@psiengines.com
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(CCXI) Positive Results From ChemoCentryx Phase II Diabetic Nephropathy Trial

— Significant reduction in proteinuria over 52 weeks of treatment suggests CCX140 may have renoprotective effects exceeding current standard of care alone —

— Separately, poster describing anti-thrombogenic potential of complement C5a receptor inhibitor CCX168 in serum from patients with atypical hemolytic uremic syndrome (aHUS) to be presented —

MOUNTAIN VIEW, Calif., May 28, 2015  — ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced data presentations from two of its chemoattractant receptor programs, CCR2 and C5aR, at the 52nd European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress being held May 28 to 31 in London, UK.

Today, in a Late Breaking Clinical Trial presentation, positive 52-week data from the Company’s Phase II clinical trial in patients with diabetic nephropathy with CCX140, an inhibitor of the chemokine receptor known as CCR2, were presented by Professor Dick de Zeeuw, M.D., Ph.D., Chair of the Research Section of the Department of Clinical Pharmacy and Pharmacology at the University Medical Center in Groningen, The Netherlands. Professor de Zeeuw’s oral presentation focused on the CCX140 Phase II study and its primary endpoint.

“We are pleased to have such an esteemed nephrologist as Professor de Zeeuw present his analyses of the results from our Phase II study in patients with diabetic nephropathy. The focus of his presentation on the treatment effect of CCR2 inhibition on reducing levels of albuminuria, the study’s primary endpoint, is particularly relevant given Professor de Zeeuw’s expertise and understanding of proteinuria and its effect on renal function,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer, ChemoCentryx. “We look forward to presenting additional CCX140 Phase II data, including important pre-specified subgroup analyses at future medical meetings.”

As previously announced, top line data from the CCX140 Phase II trial in patients with diabetic nephropathy included the following results:

  • The trial met its primary endpoint by demonstrating that treatment with 5 mg of CCX140 given orally once daily added to a standard of care regimen (SOC) of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor II blocker (ARB) treatment resulted in a statistically significant (p=0.0148) reduction in urinary albumin:creatinine ratio (UACR), beyond that achieved with SOC alone;
  • The maximum treatment effect was reached at 12 weeks; in patients who received 5 mg CCX140 continuously for 52 weeks, a sustained reduction in albuminuria induced by CCX140 relative to SOC alone was observed over the full year;
  • Treatment with CCX140 showed improvements in the profile of the estimated glomerular filtration rate (eGFR), represented by an attenuation in the slope of annual decline in eGFR. The treatment group receiving 5 mg of CCX140 in addition to SOC showed an attenuated annual slope decline of 1.9 mL/min/1.73 m2, compared to SOC alone group, 3.4 mL/min/1.73 m2. These results represent a 44 percent annualized improvement in eGFR over SOC alone;
  • In a pre-specified sub-population in the study, patients who were highly proteinuric (baseline albuminuria levels of 800mg/g creatinine and above), a 66 percent annualized relative improvement in eGFR slope over SOC alone was observed;
  • CCX140 appeared to be well tolerated with a low overall dropout rate over the 52-week treatment period.

Regarding another chemoattractant receptor inhibitor program at the Company, ChemoCentryx scientists and their collaborators will outline research in atypical Hemolytic Uremic Syndrome (aHUS) and the ability of CCX168, a C5aR inhibitor, to significantly reduce the formation of platelet micro-thrombi on an ex-vivo assay system of endothelial cells. These data will be presented in a poster session on Saturday, May 30th. The inhibition of micro-thrombi was dose-dependent on CCX168 and, in side-by-side experiments, the anti-thrombotic effect of CCX168 was comparable to that of eculizumab, which is the first agent approved for aHUS. The Company is initiating a CCX168 Phase IIa proof-of-concept study in aHUS patients with end stage renal disease.

About the CCX140 Study

The objectives of the Phase II study, which took place at multiple sites across six European countries, were to determine the safety, tolerability and signs of clinical effect of CCX140 in patients with diabetic nephropathy. CCX140 was studied in a randomized, double-blind, placebo controlled clinical trial in 332 patients with residual albuminuria, despite having received an ACE inhibitor or ARB for at least eight weeks prior to screening for this trial. The original protocol had a 12-week treatment period that was extended to 52 weeks by protocol amendment. Of the 332 patients enrolled in the study initially, 102 patients were ineligible to re-enroll after the protocol amendment approval due to the length of time off treatment. As such 196 patients participated in the study extension to receive treatment for 52 weeks. The primary safety objective was evaluation of the safety profile of CCX140 based on the incidence of adverse events. The primary efficacy endpoint was the evaluation of the effect of CCX140 treatment over 52 weeks on first morning urinary albumin:creatinine ratio. Secondary objectives included evaluation of the effect of CCX140 on eGFR and HbA1c. At baseline, the mean age of the study population was 63 years, the median duration of type 2 diabetes was 14.5 years and the median duration of nephropathy was 3.3 years. The baseline mean urinary ACR for the population overall was 636 mg/g creatinine and baseline mean eGFR was 63 mL/min/1.73 m2. Baseline mean arterial blood pressure was 98 mm Hg.

About CCX140

CCX140 targets the chemokine receptor known as CCR2 and is being developed as an orally administered therapy for the treatment of diabetic nephropathy, or diabetic kidney disease. CCR2 is found on subsets of monocytes and macrophages, which are cells of the immune system believed to play an important role in inflammatory processes. Blocking CCR2 is intended to reduce the abnormal monocyte- and macrophage-driven inflammatory response implicated in renal diseases such as diabetic nephropathy. CCR2 may also have a direct role in the function of other specialized cells in the kidney, where its inhibition would correlate with a positive therapeutic effect. CCX140 has successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function in patients with diabetic nephropathy.

About CCX168

CCX168, a C5aR inhibitor, targets the chemoattractant receptor known as C5aR (which binds to the complement fragment C5a). ChemoCentryx is developing CCX168 for various autoimmune disorders including anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), Immunoglobulin A nephropathy (IgAN) and atypical Hemolytic Uremic Syndrome (aHUS). CCX168 appears to be safe, well tolerated and successful in allowing both reduction and elimination of high-dose corticosteroids, part of standard of care for AAV patients, without compromising efficacy or safety during a 12-week treatment period.

About ChemoCentryx

ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. CCX140, a CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function in patients with diabetic nephropathy. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing both reduction and elimination of high-dose corticosteroids, part of standard of care for AAV patients, without compromising efficacy or safety during a 12-week treatment period. CCX872, a second CCR2 inhibitor, successfully completed Phase I development and is in development for the treatment of non-resectable pancreatic cancer. Vercirnon (also known as Traficet-EN or CCX282) is a specific CCR9 inhibitor for the treatment of inflammatory bowel disease. Other clinical programs include CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.

Forward-Looking Statements

ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include statements regarding whether CCX140 will be shown to be effective in Phase III clinical trials in the treatment of diabetic nephropathy or whether CCX168 will be effective in the treatment of atypical hemolytic uremic syndrome. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ChemoCentryx’s periodic reports filed with the SEC, including ChemoCentryx’s Annual Report on Form 10-K filed with the SEC March 13, 2015 and its other reports which are available from the SEC’s website (www.sec.gov) and on ChemoCentryx’s website (www.chemocentryx.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Source: ChemoCentryx (CCXI-G)

CONTACT: Susan M. Kanaya
         Senior Vice President, Finance and
         Chief Financial Officer or
         Markus J. Cappel, Ph.D.
         Chief Business Officer
         650.210.2900
         investor@chemocentryx.com

         Media:
         Denise Powell
         510.703.9491
         denise@redhousecomms.com

         Investors:
         Kimberly Minarovich
         Burns McClellan
         212.213.0006
         kminarovich@burnsmc.com
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(ATNM) Actimab-A High Response Rates Presented at 2015 ASCO Annual Meeting

Clinical Advisory Board Chairman Dr. Joseph Jurcic Presents Data From Ongoing Actimab-A Phase I/II Clinical Trial

NEW YORK, NY–(May 29, 2015) – Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced its poster and abstract at ASCO 2015, the 51st Annual Meeting of American Society of Clinical Oncology, held in Chicago on May 29 – June 2. Data will be presented from the Company’s ongoing multi-center Phase 1/2 Study for Actimab-A for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in elderly patients.

Clinical data from the first three cohorts, totaling 12 patients, will be discussed. Two Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi) and one patient achieved complete remission with incomplete platelet count recovery (CRp), for a combined overall response rate of 25% among all patients and 67% among patients treated at the highest dose level to date. Patients ranged from 68 to 87 years of age, all with high- or intermediate-risk cytogenetics; half of them had prior MDS therapy. Dose limiting toxicities were limited to one patient with prolonged myelosuppression. No extramedullary dose limiting toxicities were observed. Patients had high pre-treatment leukemia burdens of up to 88% in the bone marrow, and half had blast reductions > 50% after Actimab-A treatment. The Company also recently began the fourth and last cohort (2.0 μCi/kg per dose) in the Phase I portion of this trial..

“We have seen dramatic reductions in bone marrow blasts after just one cycle of low-dose cytarabine and Actimab-A, much more so than would be expected with chemotherapy alone,” stated Joseph Jurcic, MD, Director of the Hematologic Malignancies Section of the Hematology/Oncology Division of Columbia University Medical Center in New York and lead author of the poster and abstract. “Moreover, these blast reductions have led to objective responses in a group of older patients with AML who would not benefit from intensive chemotherapy approaches. Actimab-A could play a major role in the treatment of this particularly challenging group of patients who currently have no standard treatment options.” Further details on Dr. Jurcic’s poster presentation are below.

Title: Phase I trial of α-particle therapy with actinium-225 (225Ac)-lintuzumab (anti-CD33) and low-dose cytarabine (LDAC) in older patients with untreated acute myeloid leukemia (AML). (ASCO Abstract #7050)

Date/Time: Sunday, May 31, 2015, 8:00 AM – 11:30 AM

Location: McCormick Place, Chicago, IL; Poster Board #39 in S Hall A

Dr. Jurcic is Director of the Hematologic Malignancies Section of the Hematology/Oncology Division and Professor of Clinical Medicine at Columbia University Medical Center. He is a hematologist/oncologist focusing on the treatment of acute and chronic leukemias, myeloproliferative neoplasms, and myelodysplastic syndrome. His research interests include acute myeloid leukemia, radioimmunotherapy with alpha and beta particle-emitting radioisotopes, monoclonal antibody therapy for leukemia, development of novel small molecule inhibitors for leukemia and molecular monitoring of minimal residual disease. He is the primary investigator for the current Actimab-A clinical trial and Clinical Advisory Board Chairman. He received his medical degree from the University of Pennsylvania and completed his fellowship in Hematology-Oncology at Memorial Sloan-Kettering Cancer Center.

About Actimab-A

Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 clinical trial. Based on Actinium’s alpha-particle immunotherapy (APIT) platform, Actimab-A consists of the CD33 antibody lintuzumab linked to the actinium-225 payload. Actimab-A has attracted support from leading experts at the prestigious and high-volume cancer treatment hospitals due to the potential of its safety and efficacy profile, as well as its potential potency, specificity and ease of use. Clinical trials are being conducted at world-class cancer institutions such as Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Johns Hopkins Medicine, Columbia University Medical Center, University of Pennsylvania Health System, Fred Hutchinson Cancer Research Center, and the Texas Oncology-Baylor Charles A. Sammons Cancer Center. Actimab candidates are in early development for other cancers.

About Iomab-B

Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM).

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company’s second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.

This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Contact:

David Gould, MD
SVP, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
dgould@actiniumpharma.com

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(DCTH) Positive Data With Delcath’s CHEMOSAT Highlighted At ASCO 2015

Single-center experience in Europe illustrates safe control of hepatic metastases with the Delcath Hepatic CHEMOSAT Delivery System

NEW YORK, May 29, 2015  — Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces that results of a large, European single-center experience of the treatment of uveal melanoma patients with hepatic metastases with the Delcath Hepatic CHEMOSAT® Delivery System, were highlighted in an on-line abstract at the American Society of Clinical Oncology Annual Meeting 2015.  The abstract is titled, “Single Centre Experience of Chemosaturation Percutaneous Hepatic Perfusion in the Treatment of Metastatic Uveal Melanoma” and can be accessed here.

Uveal melanoma (UM), also known as ocular melanoma, is a rare cancer of the eye with a very poor prognosis. According to the study authors, “50% of patients develop distant disease, mainly in the liver (90%), with a mean survival of 6 months and 1-year survival rate of 15-20%.”

In this study, 20 patients received 34 treatments with CHEMOSAT (1-3 treatments per patient). Radiologically, 2 patients (10%) demonstrated stable disease for >3 months, 13 patients (65%) had a partial response in the liver with complete responses in 2 patients (10%). Nine deaths from disease progression occurred after a median of 264 days from the first procedure. Eleven patients remain alive after a median of 280 days with one complete response ongoing at >1 year. From the diagnosis of liver metastases, 11 patients (55%) have survived to one year and 3 (15%) for >2 years. No procedure related deaths were seen.

Adverse events (AEs) seen were grade 1 (n=12), 2 (n=13), 3 (n=5) and 4 (n=1). The grade 4 complication was pulmonary edema due to fluid overload. Early AEs often expected with percutaneous hepatic perfusion (PHP) were observed including coagulopathy, electrolyte disturbances and transient transaminases (elevated liver enzymes).  Rare late AEs (1 patient each) included hair loss, skin rash, myelosuppression and persistent transaminases (elevated liver enzymes).

“Our results show that PHP (CHEMOSAT) can be used safely to control hepatic metastases in selected UM patients with a high rate of hepatic progression free and excellent overall survival,” concluded lead study author, Guy Hickson, M.D., Southampton Hospital, Interventional Radiology, Southampton, United Kingdom.

“We are especially pleased to have these data shared with the thousands of oncology specialists from around the world who attend ASCO.  We continue to be encouraged by the growing body of European commercial patient experience that illustrates CHEMOSAT’s ability to safely and effectively enhance hepatic progression free and overall survival rates in cancer patients with limited treatment options and life-limiting disease,” noted Jennifer Simpson, Ph.D., President and Chief Executive Officer of Delcath.

CHEMOSAT is a CE Marked approved product in Europe and is not approved in the United States.

About Ocular (Uveal) Melanoma
According to the National Cancer Institute, ocular (uveal) melanoma is a rare cancer that forms from cells that make melanin in the iris, ciliary body, and choroid. It is the most common eye cancer in adults, affecting one in every 5 million people in the U.S., with comparable incident rates in Europe.

About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers. Our proprietary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure. In April 2012 we obtained authorization to affix a CE Mark to our second-generation system, which is currently marketed in Europe as a device under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the U.S. Food and Drug Administration (FDA). The Melphalan/HDS system has not been approved for sale in the U.S. We have commenced a global Phase 2 clinical trial in Europe and the U.S. to investigate the Melphalan/HDS system for the treatment of primary liver cancer (HCC), and expect to initiate a global Phase 3 trial in ocular melanoma (OM) that has metastasized to the liver and plan to evaluate intrahepatic cholangiocarcinoma (ICC) in a Phase 2 clinical study.

Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the impact of the poster presentation at ASCO 2015 and future clinical results consistent with the data presented, timely patient enrollment the ability to complete an interim evaluation of the Company’s Global Phase 2 HCC program, ,  the timing and results of the Company’s  clinical trials including without limitation the HCC, ICC  and OM  clinical trial programs  timely enrollment and treatment of patients in the global Phase 2 HCC and ICC clinical trial, FDA approval of the global Phase 3 OM clinical trial protocol, IRB or ethics committee clearance for certain Phase 2 HCC/ICC  and/or Phase 3 OM  protocols from  participating sites and the timing of site activation and subject enrollment in each trial, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any  of Value 4 status on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets, the Company’s ability to satisfy the requirements of the FDA’s Complete Response Letter and provide the same in a timely manner, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Contact Information:
Investor Contact:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777

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(DATE) Receives Additional Non-Binding Proposals

BEIJING, May 29, 2015  — Jiayuan.com International Ltd. (“Jiayuan” or the “Company”) (NASDAQ: DATE), operator of the largest online dating platform in China, today announced that the special committee (the “Special Committee”) of the Company’s board of directors (the “Board”), which was formed to review and evaluate the non-binding proposal letter, dated March 3, 2015, from Vast Profit Holdings Limited (“Vast Profit”) that proposes a “going-private” transaction involving the acquisition of all of the outstanding ordinary shares of the Company not already owned by Vast Profit, has received and is evaluating additional non-binding proposals regarding a potential transaction regarding the Company.

The Board cautions the Company’s shareholders and others considering trading in the Company’s securities that no decisions have been made by the Special Committee with respect to the Company’s response to any proposal and there can be no assurance that any definitive offer will be made, that any agreement will be executed or that any transaction will be approved or consummated.

About Jiayuan

Jiayuan.com International Ltd. (“Jiayuan”) (NASDAQ: DATE) operates the largest online dating platform in China. Jiayuan is committed to providing a trusted, effective, and user-focused online dating platform that addresses the dating and marriage needs of China’s rapidly growing urban singles population. As a pioneer in China’s online dating market, Jiayuan ranks first in terms of number of unique visitors, average time spent per user and average page views per user among all online dating websites in China in 2014, according to iResearch. Jiayuan recorded an average of 5.4 million monthly active user accounts in the fourth quarter of 2014. Every two of Jiayuan’s American Depositary Shares represent three ordinary shares.

For more information, please visit http://ir.jiayuan.com.

Forward-Looking Statements

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Jiayuan may also make written or verbal forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in verbal statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: our growth strategies; our future business development, including development of new products and services; our ability to attract and retain users; competition in the Chinese online dating markets; changes in our revenues and certain cost or expense items as a percentage of our revenues; the outcome of any litigation or arbitration; the expected growth of the number of Internet and broadband users in China; Chinese governmental policies relating to the Internet and online dating websites and general economic conditions in China and elsewhere. Further information regarding these and other risks is included in our documents filed with the U.S. Securities and Exchange Commission. Jiayuan does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release is as of the date of the press release, and Jiayuan undertakes no duty to update such information, except as required under applicable law.

For investor and media inquiries, please contact:
China
Shirley Zhang
Jiayuan.com International Ltd.
+86 (10) 6442-2321
ir@jiayuan.com
Mr. Christian Arnell
Christensen Investor RelationsMr. Christian Arnell
+86-10-5900-1548
carnell@christensenir.com
US
Ms. Linda Bergkamp+1-480-614-3004
Email: lbergkamp@Christensenir.com
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(TBIO) Launches Multiplexed ICE COLD-PCR™ Enabled EGFR CLIA Test

Transgenomic, Inc. (NASDAQ:TBIO) today announced the launch of its new Multiplexed ICE COLD-PCR™ (MX-ICP) CLIA service for mutation detection in cancer patients to enable more informed diagnoses, better treatment decisions and ongoing patient monitoring. The service leverages the ultra-high sensitivity of Transgenomic’s proprietary MX-ICP technology to deliver highly accurate results from almost any type of patient sample. The first tests are for the detection of EGFR exon 20 T790M mutations that affect the utility of tyrosine kinase inhibitor (TKI) drugs used for non-small cell lung cancer and EGFR exon 12 S492R mutations that render colorectal cancer patients resistant to the widely-used drug cetuximab. Transgenomic intends to add additional single mutation and mutation panel detection tests to its suite of testing services in the coming months.

Bruce E. Johnson, MD, Chief Clinical Research Officer, Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School, noted, “The development of an accurate means to detect EGFR T790M with a blood test is an important development for our patients. We anticipate different drugs will be approved later this year for patients with acquired resistance to EGFR-TKIs and the presence of T790M in their tumor. Approximately 30% of our patients at the time of progression on EGFR-TKIs are unable to be biopsied, so an alternative means of testing using a blood-based test for assessing their status will be critical for this subset of EGFR-mutant NSCLC patients.”

“Launching our Multiplexed ICE COLD-PCR-based CLIA mutation detection service for oncologists and their patients is a major milestone for Transgenomic and, we believe, an important advance for the field of precision medicine,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “The unsurpassed accuracy of MX-ICP and its ability to produce highly sensitive and accurate results from small amounts of almost any type of patient sample, especially liquid biopsies, allows broad use. This will enable far more patients to benefit from therapy optimized for their specific cancer and the insights into disease and treatment status obtained from ongoing monitoring during therapy, unlike currently-used tissue biopsies. Our first two tests focus on common treatment-relevant mutations in lung and colon cancer, and we intend to add new tests and test panels for other mutations and additional cancers in the coming months.”

Multiplexed ICE COLD-PCR achieves its ultra-high sensitivity by preferentially enriching the scarce mutant DNA sequences present in an ocean of wild-type (normal) DNA through selective amplification of the mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available–down to 0.01% from as little as 4-5 ml of plasma sample, making it possible to obtain accurate and sensitive biopsies using either liquid or solid tissue specimens. ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

The new service will accept a wide range of patient samples, including tissue, plasma, fine needle aspiration, bronchoscopy, cytology and other body fluid samples. Actionable results will be available in 7-10 working days. Additional tests and panels for mutations in EGFR, KRAS, NRAS, PIK3CA, BRAF and other genes are currently in development.

Transgenomic also announced the publication and availability of a study abstract at the 2015 ASCO Annual Meeting website and at our booth confirming the clinical utility of expanded screening of KRAS and NRAS genes in colorectal cancer patients using Transgenomic’s CRC RAScan™ test.1

KRAS and NRAS mutations are found in approximately one-quarter of human tumors. They lead to activation of RAS family genes that play a critical role in determining response to EGFR mutation-targeted therapies such as cetuximab and panitumumab. Presence of KRAS exon 2 mutation status has been used as a key predictor of response to anti-EGFR therapy. However, about 10% of patient tumors that do not have a mutation in KRAS exon 2 have been found to have mutations in KRAS exons 3 or 4 or in NRAS exons 2, 3, or 4, which also respond poorly to anti-EGFR treatment. Evaluation of colorectal cancer cases tested in Transgenomic’s laboratory facility identified almost one-quarter with these mutations. Of these, 45% had the expected mutation in KRAS exon 2, but the other 55% had mutations in KRAS exon 3 or 4, or in NRAS exon 2 and 3. These findings suggest that screening for mutations in these other gene regions could play an important role in improved management of colorectal cancer. The authors conclude that the study results confirm that using the CRC RAScan test as a screen ensured the more effective use of anti-EGFR therapies for individuals with metastatic colorectal cancer.

For more information on Transgenomic’s CLIA services for KRAS and NRAS testing, click here. For more information on its EGFR CLIA tests, click here.

1 Clinical utility of expanded screening of the KRAS and NRAS genes for Metastatic Colorectal Cancer: Evaluation of the CRC RAScan tumor test as a companion diagnostic to determine efficacy of anti-EGFR therapies. KA Richardson, S Peterson, J Bevilacqua, S Veys, V Rosendale, BL Legendre, KC Bible, H Reddi; Abstract No: e12554J; Clin Oncol 33, 2015 (suppl; abstr e12554)

About Transgenomic

Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE-COLD PCR™ and its unique genetic tests provided through its Patient Testing business. The company also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies and sells equipment, reagents and other consumables for applications in molecular testing and cytogenetics. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic’s filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Media Contact
BLL Partners LLC
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
or
Investor Contact
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com

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(ARCI) Board & CEO Overhaul At Appliance Recycling Centers of America

SAN DIEGO, May 28, 2015  — Isaac Capital Group LLC (ICG), an International private investment firm based in San Diego, California, and largest shareholder of Appliance Recycling Centers of America (Nasdaq:ARCI), with ownership of approximately 12 percent of the outstanding common stock of the company, today announced that it has nominated new members to the Company’s Board of Directors, replacing the majority of the old Board. In addition, ICG has confirmed the reinstatement of ARCA’s founder, Edward “Jack” Cameron, who served as CEO from 1976 to 2014 at the $130 Million per year, Minneapolis-based company.

Appliance Recycling Centers of America, Inc., sells and recycles new household appliances through a chain of company-owned retail stores under the ApplianceSmart name. The company operates in two segments, Recycling and Retail. Its stores offer new appliances and special-buy appliances. The company operates 18 ApplianceSmart stores in Minnesota, Ohio, Georgia, and Texas. It also provides turnkey appliance recycling and replacement services for electric utilities and other sponsors of energy efficiency programs.

“ARCA has spent four decades providing the public with energy efficient appliances and technology, while providing the means to cleanly and safely dispose of old ones,” said Jon Isaac, managing member of Isaac Capital Group LLC. “As technology continues to advance, it makes sense to us to ensure that the company continues to be run by the man who founded it and has kept it profitable for nearly 40 years with the support of an experienced and qualified board that can help guide the company into its next 40 years.”

About ARCA

ARCA’s three business components are uniquely positioned in the industry to work together to provide a full array of appliance-related services. ARCA Advanced Processing, LLC employs advanced technology to refine traditional appliance recycling techniques to achieve optimal revenue-generating and environmental benefits. ARCA is also the exclusive North American distributor for UNTHA Recycling Technology (URT), one of the world’s leading manufacturers of technologically advanced refrigerator recycling systems and recycling facilities for electrical household appliances and electronic scrap. ARCA’s regional centers process appliances at end of life to remove environmentally damaging substances and produce material byproducts for recycling for utilities in the U.S. and Canada. Eighteen company-owned stores under the name ApplianceSmart, Inc.® sell new appliances directly to consumers and provide affordable ENERGY STAR® options for energy efficiency appliance replacement programs.

About ICG

Isaac Capital Group (ICG) is a private investment firm based in San Diego, which makes highly selective, long-term investments in companies it deems to have strong management teams. Its investments are across a variety of industries and focus on creating value through growth and superior performance. The firm’s comprehensive approach to due diligence execution, research and market analysis, paired with its ability to identify unique opportunities, had allowed for expansive growth and development within its investment portfolio.

Isaac Capital Group is the largest shareholder in LiveDeal Inc. (Nasdaq:LIVE), a company with a geo-location based mobile marketing platform that enables restaurants to publish “real-time” and “instant offers” to nearby consumers, which has seen tremendous share appreciation since ICG became involved in 2011.

CONTACT: Sara Pinneo
         ICG
         858-259-6666
         s.pinneo@isaac.com
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(REPH) to Present at the Jefferies 2015 Global Healthcare Conference

MALVERN, Pa., May 28, 2015  — Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute post operative pain, today announced that Gerri Henwood, the Company’s President and Chief Executive Officer, will present at the Jefferies 2015 Global Healthcare Conference on Thursday, June 4, 2015, at 9:30 am EDT. The conference is being held at the Grand Hyatt in New York City.

Live and archived webcasts of the presentation will be available on the Presentations page of the Company’s website at http://recropharma.com.

About Recro Pharma, Inc.

Recro Pharma is a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute post operative pain. Recro Pharma is currently developing IV/IM meloxicam, a proprietary, Phase III-ready, long-acting preferential COX-2 inhibitor, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine currently being tested in Phase II, for the treatment of acute post operative pain. As Recro Pharma’s product candidates are not in the opioid class of drugs, the Company believes its candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory distress, while maintaining analgesic effect.

Recro Pharma also owns and operates an 87,000 square foot, DEA-licensed facility that manufactures five commercial products and receives royalties associated with the sales of these products.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Recro Pharma’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target,” “intend” and “expect” and similar expressions, as they relate to Recro Pharma or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Recro Pharma as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Recro Pharma’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. Recro Pharma assumes no obligation to update any such forward-looking statements. Factors that could cause Recro Pharma’s actual results to materially differ from those expressed in the forward-looking statements set forth in this press release include, without limitation: the results and timing of the clinical trials of IV/IM meloxicam and Dex-IN and any future clinical and preclinical studies; the ability to obtain and maintain regulatory approval of product candidates, and the labeling under any such approval; regulatory developments in the United States and foreign countries; the Company’s ability to raise future financing for continued development; the performance of third-party suppliers and manufacturers; the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection; the successful commercialization of the Company’s product candidates; the successful implementation of the Company’s strategy; the Company’s ability to integrate the recent acquisition of assets from Alkermes; and the Company’s ability to meet required debt payments and operate under increased leverage and associated lending covenants in connection with the recent acquisition. In addition, the forward-looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro Pharma’s business and future results included in Recro Pharma’s filings with the Securities and Exchange Commission at www.sec.gov. Recro Pharma assumes no obligation to update any such forward looking statements.

CONTACT: Recro Pharma, Inc.
         Charles T. Garner
         Chief Financial Officer
         (484) 395-2425

         Media and Investors:
         Argot Partners
         Susan Kim
         (212) 600-1902
         susan@argotpartners.com
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(GENE) Clinically Validated Brevagenplus(R) Accurately Identifies Sporadic Breast Cancer Risk

CHARLOTTE, N.C., May 28, 2015  — Phenogen Sciences, Inc., the U.S. subsidiary of Australia-based Genetic Technologies Limited (NASDAQ: GENE), today notes with interest the special report on May 27, 2015 in The New England Journal of Medicine entitled, “Gene-Panel Sequencing and the Prediction of Breast Cancer Risk” authored by DF Easton, et al. The company’s lead product, BREVAGenplus, is a clinically validated, genetically-based predictive risk test for sporadic, or non-hereditary, breast cancer.

Richard Allman, Ph.D., Scientific Director, Genetic Technologies Ltd. states, “While the BREVAGenplus test does not evaluate gene-panel sequencing or hereditary cancer testing, we welcome the findings of the authors which re-inforce the message that adequate validation is required for cancer risk assessment tests.”

According to The New England Journal of Medicine article, there is a reasonably clear distinction between single nucleotide polymorphisms (SNPs) that confer a small increased susceptibility to breast cancer and variants that confer a moderate-to-high susceptibility as identified through sequencing.1 BREVAGenplus evaluates a panel of SNPs known to be associated with sporadic breast cancer combined with clinical risk factors to provide a more accurate risk assessment.

How BREVAGenplus Works

The BREVAGenplus predictive risk test is performed in a physician’s office using a simple, non-invasive “cheek swab.” The test combines information from the patient’s genetic markers (SNPs) known to be associated with sporadic breast cancer, with their Clinical Risk Score which includes factors such as the patient’s current age, age at menarche, age at live first birth, race/ethnicity, etc, to calculate their risk of developing sporadic breast cancer. This Clinical Risk Score is determined by the National Cancer Institute Breast Cancer Risk Assessment Tool (BCRAT); also known as the “Gail model” (http://www.cancer.gov/bcrisktool/).

Following analysis in a CLIA-certified laboratory, the test provides five-year and lifetime predictive risk assessments to more accurately determine the patient’s risk of developing breast cancer during those timeframes.

Clinically Validated, Proven Superior

The first generation test, BREVAGen™, was proven superior in determining breast cancer risk compared to Clinical Risk Score alone (ie, “Gail model score.”).2 In the U.S. Women’s Health Initiative (WHI) Clinical Trial, 3,300 women underwent breast cancer assessment utilizing the BREVAGen test. Studies showed BREVAGen reclassified 64 percent of above average (ie, “intermediate”) risk (as determined by the Gail model) subjects as either high or low risk for development of breast cancer. Furthermore, the BREVAGen test reclassified the breast cancer risk for 33 percent of the total 3,300 trial subjects.2

BREVAGenplus expands on this initial work by leveraging recent advancements in SNP research and development. BREVAGenplus incorporates a ten-fold increase in the number of genetic markers over the first generation test. In addition, the applicability of BREVAGenplus has been expanded to include African-American and Hispanic women, whereas the BREVAGen test was only applicable to Caucasian women.

There is no single mutation for sporadic breast cancer, nor is there a repository of information about genetic contribution to a complex disease such as breast cancer. At present, the measurable genetic markers associated with complex diseases are identified using genome-wide association (GWA) studies. GWA studies have been used to identify novel breast cancer susceptibility loci. Several dozens of SNPs were identified for BREVAGenplus testing based on an initial review of over 500,000 SNPs in multiple GWA studies involving over 50,000 women.3,4

About BREVAGenplus

An enhancement of Phenogen Sciences, Inc. first generation product, BREVAGen, BREVAGenplus evaluates an increased number of genetic markers (SNPs); and testing is now available for African-American and Hispanic American women.

BREVAGenplus is a clinically-validated, personalized predictive risk assessment test that more accurately evaluates a woman’s personal risk of developing sporadic, or non-hereditary, breast cancer. By evaluating a woman’s clinical information (Gail score) and genetic markers (SNP profile), BREVAGenplus assists physicians in developing personalized risk management plans and taking appropriate steps towards managing each woman’s risk of developing sporadic breast cancer with greater precision than ever before.

Phenogen Sciences, Inc. markets BREVAGenplus to healthcare providers in women’s health, primarily obstetricians/gynecologists (OBGYNs), breast cancer risk assessment specialists (such as breast surgeons) and comprehensive breast health care and imaging centers. For more information, visit http://www.brevagenplus.com.

About Phenogen Sciences, Inc.

Phenogen Sciences, Inc., the U.S. subsidiary of Australia-based Genetic Technologies Limited, is a pioneer in personalized healthcare. Phenogen Sciences offers novel predictive testing and assessment tools that help physicians proactively manage women’s health risks. Phenogen Sciences’ product, BREVAGenplus is a scientifically validated test that combines a woman’s clinical history with a panel of genetic markers to more accurately categorizing her personal risk of developing breast cancer. For more information, visit http://www.phenogensciences.com.

About Genetic Technologies Limited

Genetic Technologies (NASDAQ: GENE) is a molecular diagnostics company that offers predictive testing and assessment tools to help physicians proactively manage women’s health. The Company’s lead product, BREVAGenplus®, is a clinically validated risk assessment test for non-hereditary breast cancer and is first in its class. BREVAGenplus improves upon the predictive power of the first generation, BREVAGen™ test and is designed to facilitate better informed decisions about breast cancer screening and preventive treatment plans. BREVAGenplus expands the application of BREVAGen from Caucasian women to include African-Americans and Hispanics, and is directed towards women aged 35 years or above, who have not had breast cancer and have one or more risk factors for developing breast cancer.

The Company has successfully launched the first generation BREVAGen test across the U.S. via its U.S. subsidiary Phenogen Sciences, Inc. and the addition of BREVAGenplus, launched in October 2014, significantly expands the applicable market. The Company markets BREVAGenplus to healthcare professionals in comprehensive breast health care and imaging centers, as well as to obstetricians/gynecologists (OBGYNs) and breast cancer risk assessment specialists (such as breast surgeons).

For more information, please visit http://www.brevagenplus.com.

1. Easton DF, et al. Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk. NEJM, May 2015 DOI: 10.1056/NEJMsr1501341.
2. Mealiffe ME, Stokowski RP, Rhees BK et al. Clinical validity assessment of a breast cancer risk model combining genetic and clinical information. Journal of the National Cancer Institute. 2010. 21: 1618-1627.
3. Easton DF. Pooley KA, Dunning AM, et al. (2007).  Genome-wide association study identifies novel breast cancer susceptibility loci.  Nature 447: 1087-1093.
4. Michailidou K, Hall P, Gonzalez-Neira A, et al. Large-scale genotyping identifies 41 new loci associated with breast cancer risk. Nature Genetics. 2013. 45: 353-361.

CONTACT: Bruce Likly
         Kovak-Likly Communications
         203-762-8833
         blikly@klcpr.com
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(AMRN) Granted Summary Judgment Motion in Suit Against FDA Over Vascepa(R)

NCE Supports Extensive Patent Portfolio Toward Vascepa Exclusivity Into 2030

BEDMINSTER, NJ and DUBLIN, IRELAND–(May 28, 2015) – Amarin Corporation plc (NASDAQ: AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin’s motion for summary judgment in the company’s lawsuit against the United States Food and Drug Administration (FDA) seeking an order requiring FDA to recognize five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa® (icosapent ethyl) capsules.

Amarin believes based on the court’s ruling that Vascepa is entitled to five-year marketing exclusivity starting from FDA’s approval of Vascepa in July 2012, thus extending NCE exclusivity through July 25, 2017. The ruling also confirms that acceptance by FDA of abbreviated new drug applications (“ANDAs”) for generic versions of Vascepa is not permitted until July 2016. The related statutory 30-month stay triggered by patent litigation following generic application resubmissions in July 2016 would then expire in January 2020. An appeal of the court’s decision can be filed within 60 days.

Amarin has multiple patents covering Vascepa that expire in 2030. With this motion granted and FDA’s acceptance of ANDAs not permitted, Amarin plans to move to dismiss pending Vascepa patent litigation in connection with ANDA filings previously submitted.

“Congratulations to the extended Amarin team for delivering on this value-enhancing operational goal,” stated John Thero, President and Chief Executive Officer of Amarin. “NCE exclusivity helps solidify Vascepa’s commercial potential and helps demonstrate Vascepa’s status as a significant and novel treatment option in the management of severely high triglycerides. Amarin’s goal is to protect the commercial potential of Vascepa to beyond 2030. NCE regulatory exclusivity contributes toward this goal by complementing one of the most extensive patent portfolios covering a single product in the industry and existing manufacturing barriers to entry.”

About Vascepa® (icosapent ethyl) capsules

Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.

Indications and Usage

  • Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
  • The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information for Vascepa

  • Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components and should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
  • The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

About Amarin

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin’s clinical program includes commitment to an ongoing outcomes study. Vascepa® (icosapent ethyl), Amarin’s first FDA approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.

Forward-looking statements

This press release contains forward-looking statements, including statements about Amarin’s plans to end pending ANDA-related patent litigation, require later resubmission pending generic applications; statements about maintaining Vascepa exclusivity including barriers to entry that may protect Vascepa against competition and Amarin’s plan to protect the commercial potential of Vascepa through patents and other circumstances and means. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: a determination by FDA or other interested parties to appeal or intercede in the court decision and a win on such appeal or the unwillingness of authorities to dismiss proceedings until any such appeal is heard; events that could interfere with the continued validity or enforceability of a patent; Amarin’s ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing Vascepa without violating the intellectual property rights of others; and uncertainties associated generally with research and development, clinical trials and related regulatory approvals and exclusivity grants. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of other information about Amarin

Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin contact information:
Michael Farrell
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

Graham Morrell
Trout Group
In U.S.: +1 (646) 378-2954
gmorrell@troutgroup.com

Media Inquiries
Lee Davies
Makovsky
In U.S.: +1 (212) 508-9651
ldavies@makovsky.com

Thursday, May 28th, 2015 Uncategorized Comments Off on (AMRN) Granted Summary Judgment Motion in Suit Against FDA Over Vascepa(R)

(MYOS) Receives Health Canada Approval For Fortetropin(R)

First Fertilized Egg Powder Approved in Canada

CEDAR KNOLLS, NJ–(May 28, 2015) – MYOS Corporation (“MYOS” or the “Company”) (NASDAQ: MYOS), an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve human muscle health and performance, announced today that Health Canada, has reviewed and approved Fortetropin®, the Company’s proprietary ingredient, for sale in powder dose form in Canada. Fortetropin is the first fertilized egg yolk powder ingredient to be approved by Health Canada and issued a Natural Product Number.

In order to support the incorporation of Fortetropin as a medicinal ingredient in finished products for sale in Canada, MYOS submitted evidence to the Natural and Non-prescription Health Products Directorate of Health Canada to substantiate the quality, safety and efficacy of Fortetropin. For more information about Fortetropin, a letter of access, explaining Fortetropin’s claims and uses, is available upon request.

Maghsoud Dariani, head of Science and Technology for MYOS, commented, “Our investment in, and commitment to, Fortetropin runs deep. MYOS realized the potential of this ingredient in 2011, and invested a great deal of research into manufacturing, quality control and quality assurance. Fortetropin is a bioactive proteo-lipid complex made from fertilized chicken egg yolk using a proprietary process that retains the biological integrity and bioactivity of the mixture. Egg yolk is known as one of the most nutritionally dense natural foods available, making it a strong candidate for inclusion in medical and functional foods. MYOS is very excited to have the opportunity to sell Fortetropin powder in Canada.”

Lindsey Penrose, MYOS’ Vice President of Business Development, added, “We are very pleased that Fortetropin has been granted regulatory approval by Health Canada in a powder dose form. Canadian natural health product regulations are extremely strict and we believe this approval attests to Fortetropin’s high level of safety and scientific support.”

About MYOS Corporation
MYOS is an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and function essential to the management of sarcopenia, cachexia and degenerative muscle diseases. MYOS is the owner of Fortetropin®, the first clinically proven natural myostatin inhibitor. Myostatin is a natural regulatory protein, which inhibits muscle growth and recovery. Medical literature suggests that lowering myostatin levels has many potential health benefits including increased muscle mass, healthy weight management, improved energy levels, stimulation of muscle healing as well as treating sarcopenia, a condition of age-related loss of muscle mass. To discover why MYOS is known as “The Muscle Company,”™ visit www.myoscorp.com

About Health Canada
The mission of Health Canada is to make Canada the healthiest country in the world. Relying on high quality research, Health Canada communicates information and encourages Canadians to take an active role in their health. All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004. [The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality. Through the Natural Health Products Directorate, Health Canada assures that all Canadians have ready access to a wide range of natural health products that are safe, effective and of high quality.](1)

The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.

As part of the Health Products and Food Branch of Health Canada, the Natural and Non-prescription Health Products Directorate (NNHPD) is the regulating authority for natural health products for sale in Canada. Its role is to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Source: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.php

About Rē Muscle Health™
The Rē Muscle Health™ series is the Company’s first branded line of muscle health products. This unique line of all-natural, non-GMO products contain Fortetropin®, an egg-based, all natural myostatin inhibitor clinically proven to build healthy muscle. The Rē Muscle Health™ series can be ordered by visiting www.remusclehealth.com. MYOS believes that Fortetropin®, as well as future products it envisions, will redefine existing standards for muscle health. The Rē Muscle Health™ product line is owned and sold directly by the Company at www.remusclehealth.com.

Forward-Looking Statements
Any statements in this release that are not historical facts are forward-looking statements. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements involve risks and uncertainties, including but not limited to those relating to the successful continued research of Fortetropin® and its effects on myostatin inhibition, inflammatory cytokine levels and cholesterol levels, the successful launch and customer demand for our Rē Muscle Health™ and other products, the continued growth of repeat purchases, market acceptance of our existing and future products in countries outside of the United States (such as Canada), the ability to create new products through research and development, growth in our revenue, the successful entry into new markets including the age management market, the ability to collect our accounts receivable from our distributors, our ability to raise capital to fund continuing operations, the ability to attract additional investors and increase shareholder value, the ability to generate the forecasted revenue stream and cash flow from sales of Fortetropin® and Rē Muscle Health™, the ability to achieve a sustainable profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, the ability to maintain and expand our manufacturing capabilities and reduce the costs of our products, the ability to comply with NASDAQ’s continuing listing standards, competition from other providers and products, risks in product development, and other factors discussed from time to time in our Securities and Exchange Commission filings. We undertake no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made except as required by law.

These statements have not been evaluated by the Food and Drug Administration. Our products are not intended to diagnose, treat, cure or prevent any disease.

MYOS Corporation Investor and Media Contact:

MYOS Corporation
(973) 509-0444
Email Contact

Thursday, May 28th, 2015 Uncategorized Comments Off on (MYOS) Receives Health Canada Approval For Fortetropin(R)

(OHGI) Aishuo App Now Supporting Chinese Mobile Payment Platforms

LIMERICK, IRELAND–(May 28, 2015) – One Horizon Group, Inc. (NASDAQ: OHGI) (“One Horizon”, “We” or the “Company”), which develops and licenses bandwidth efficient mobile voice over Internet Protocol (“VoIP”) platform for smartphones, announced that its Chinese retail VoIP service, brand named Aishuo, now supports all of the major Chinese mobile payment platforms including China UnionPay, Alibaba’s Alipay and Tencent’s Wechat Wallet to support a range of premium Aishuo app services.

The Aishuo rollout to Chinese smartphone users commenced in late February 2015 and has recently surpassed 3.5 million downloads. The Company is seeking to acquire 15 million new subscribers on its mobile VoIP service over a two-year period with a view to leveraging this significant user base to achieve industry average revenues per user (ARPU) for similar social media, mobile advertising and mobile VoIP apps.

The app now supports all of the major Chinese mobile payment platforms including China UnionPay, Alibaba’s Alipay and Tencent’s Wechat Wallet giving users the option to purchase Aishuo credit which allows them to quickly subscribe to a range of premium Aishuo app services. These services currently include One Horizon’s industry leading proprietary optimized-for-mobile VoIP calling solution with competitive per minute call-rates as low as ¥0.15/min, and the Virtual SIM number rental service, which provides a local Chinese number for friends and family to call without the need for an expensive mobile plan — ideal for students and overseas travelers wishing to avoid incoming roaming fees. Aishuo is available in over 25 smartphone App stores including Baidu’s 91.com and Baidu.com, the Tencent App store MyApp.com, 360 Qihoo store 360.cn and the hugely exciting newcomer Xiaomi on mi.com

“From a monetization perspective this is an important development for Aishuo, as our premium features are now easily funded through all of the most popular mobile payment platforms in China,” said Brian Collins, Founder and CEO of One Horizon. “Combined with our significant increase in the app download rate, we expect a ramp up of revenues from premium services as customers choose to add low cost voice minutes and rental of Chinese telephone numbers to their app usage.”

About One Horizon Group, Inc.

One Horizon Group Inc.’s business is to optimize communications over the Internet through its wholly owned subsidiary, Horizon Globex GmbH, Zug, which develops and markets one of the world’s most bandwidth-efficient mobile voice over Internet Protocol (VoIP) platforms for smartphones, and also offers a range of other optimized data Applications including messaging and mobile advertising. The company controls and operates the Aishuo mobile VoIP service in China. Horizon Globex GmbH is an ISO 9001 and ISO 20000-1 certified company. The Company has operations in Ireland, Switzerland, the United Kingdom, China, India, Singapore and Hong Kong. For more information on the Company, its products and services, please visit http://www.onehorizongroup.com.

Safe Harbor Statement

This news release may contain “forward-looking” statements. These forward-looking statements are only predictions and are subject to certain risks, uncertainties and assumptions that could cause actual results to differ from those in the forward looking-statements. Potential risks and uncertainties include such factors as uncertainty of consumer demand for the Company’s products, as well as additional risks and uncertainties that are identified and described in Company’s SEC reports. Actual results may differ materially from the forward-looking statements in this press release. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company does not undertake, and it specifically disclaims, any obligation to update any forward-looking statements to reflect occurrences, developments, events or circumstances after the date of such statement.

Contact:
Ted Haberfield
MZ Group
President – MZ North America
Direct: 760-755-2716
Mobile: 858-204-5055
Email Contact
www.mzgroup.us

Thursday, May 28th, 2015 Uncategorized Comments Off on (OHGI) Aishuo App Now Supporting Chinese Mobile Payment Platforms

(GALE) Abstracts Published, 2015 American Society of Clinical Oncology Announcement

  • GALE-301 demonstrates promising preliminary efficacy data with a projected 78% reduction in relative risk of recurrence in the 1000 mcg dose cohort
  • Leica Biosystem’s Bond Oracle HER2 Immunohistochemistry (IHC) System distinguishes HER2 1+ and 2+ expressions and supports its use as a companion diagnostic for NeuVax™ (nelipepimut-S)

PORTLAND, Ore., May 27, 2015  — Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced two abstract publications at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.

“The two abstracts published by ASCO provide meaningful advancements for both of our cancer immunotherapy programs, NeuVax and GALE-301,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “The use of Leica’s Bond Oracle HER2 IHC system ensures we have enrolled the specified HER2 1+/2+ patients for our Phase 3 NeuVax™ PRESENT trial and moves us further down the path of providing targeted, personalized medicine for these women. Meanwhile, the published preliminary data from our GALE-301 program is quite promising as it shows significant reduction of recurrences with our vaccine. We expect to present more mature data at a scientific conference this Fall, and we are currently evaluating the next steps to potentially advance GALE-301 into a randomized late-stage trial to prevent recurrence in ovarian and endometrial cancers.”

GALE-301

GALE-301 (E39) is a cancer immunotherapy targeting folate binding protein receptor-alpha to prevent ovarian and endometrial cancer recurrence in the adjuvant setting. In abstract #e14031, entitled, “Preliminary Results of the Phase I/IIa Dose Finding Trial of a Folate Binding Protein Vaccine (E39+GM-CSF) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence,” data show that GALE-301 is well tolerated and elicits a strong and dose-dependent in vivo immune response. The trial is designed as a safety and dose optimization trial and is not powered for a disease free survival efficacy endpoint. However, early efficacy results from the trial are promising in the 1000 mcg dose cohort. Of the 51 patients enrolled in the trial, 29 were in the vaccinated group (15 patients at 1000 mcg vs. 14 patients at <1000 mcg) and 22 were in the control group. With 9.8 months median follow-up, the 1000 mcg dose group had only one clinical recurrence vs 11 in the vaccine group (6.7% vs. 50% CG, p = 0.01). Combining all dose groups, the complete response (CR) rate was 38% in the vaccine group vs. 50% in the control group (p = 0.41). Currently, the estimate for disease free survival at two years is 85.7% (1000 mcg dose group) vs. 19.2% for the control group (p = 0.09), for a 78% reduction in relative risk of recurrence. The full abstract can be found here.

NeuVax™ (nelipepimut-S) Companion Diagnostic

As part of the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial, Galena implemented central laboratory testing for all potential patients to confirm validated and robust entry criteria, and to ensure the enrollment of the targeted patient population. To improve accuracy and specificity for the HER2 1+ and 2+ status testing, and develop a companion diagnostic for NeuVax, the Leica Bond Oracle™ HER2 Immunohistochemistry (IHC) system has been incorporated as central HER2 screening for the PRESENT study.

In abstract #e11609, entitled, “Analytical Validation of BOND Oracle HER2 IHC System for Identifying Low to Intermediate HER2 Expressing Breast Cancer in NeuVax PRESENT Phase 3 Clinical Trial,” data demonstrate a direct correlation between cell line receptor load, quantitative measure of HER2 protein, and IHC score. The ability to discriminate HER2 protein expression at the low and intermediate levels in breast cancer tumors will identify patients for new treatments in development such as NeuVax. Specifically, the validation of the Bond Oracle HER2 IHC System to distinguish lower levels of HER2+ expressions supports its use as a companion diagnostic. The full abstract can be found here.

About GALE-301 (Folate Binding Protein)

GALE-301 (Folate Binding Protein (FBP)) is a cancer immunotherapy targeting the prevention of cancer recurrence in the adjuvant setting. GALE-301 targets folate binding protein receptor-alpha, a well-validated therapeutic target, is highly over-expressed in ovarian, endometrial and breast cancers. FBP is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. GALE-301 consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena has completed enrollment in a Phase 2a trial with GALE-301 in two gynecological cancers: ovarian cancer and endometrial adenocarcinomas (clinicaltrials.gov identifier: NCT01580696).

About Ovarian/Endometrial Cancers

Ovarian cancer occurs in more than 40,000 women per year in the U.S. and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20% of that of breast cancer, the number of patients who die from ovarian cancer is nearly 50% of that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse, and once the disease recurs, treatment options are limited and successes of subsequent interventions drop dramatically.

Endometrial cancer is the most common gynecologic cancer and occurs in more than 46,000 women with more than 8,000 deaths in the U.S. annually. There are two basic types of endometrial cancer: endometrioid and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. NeuVax has been shown to bind to HLA-A2 and A3, as well as HLA-A24 and A26 molecules. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.

NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). Additional information on the PRESENT trial can be found at www.neuvax.com (clinicaltrials.gov identifier: NCT01479244). Galena has two additional breast cancer studies ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in neoadjuvantly treated node positive and negative HER2 IHC 3+ patients not achieving a pathological complete response (pCR) or adjuvantly treated node positive HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698).

About HER2 1+/2+ Breast Cancer

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

About Leica Biosystems

Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Leica’s easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Further information can be found at www.LeicaBiosystems.com

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena’s development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company’s commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena’s clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects.  For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and development of Galena’s product candidates, including patient enrollment and preliminary results in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All other trademarks are the property of their respective owners.

CONTACT: Remy Bernarda
         SVP, Investor Relations & Corporate Communications
         (503) 405-8258
         rbernarda@galenabiopharma.com
Wednesday, May 27th, 2015 Uncategorized Comments Off on (GALE) Abstracts Published, 2015 American Society of Clinical Oncology Announcement

(SGNL) to Present at the LD Micro Invitational Conference

CARLSBAD, Calif., May 27, 2015  — Signal Genetics, Inc. (Nasdaq:SGNL) (Signal), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced that Samuel D. Riccitelli, President and Chief Executive Officer of Signal, will present a corporate overview at the LD Micro Invitational on June 1, 2015.

Event: LD Micro Invitational

Date: June 1, 2015

Time: 3:30pm PT / 6:30pm ET

About Signal Genetics, Inc.

Signal Genetics, Inc., headquartered in Carlsbad, California, is a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer. Signal’s mission is to develop, validate and deliver innovative diagnostic services that enable better patient-care decisions. Signal was founded in January 2010 and became the exclusive licensee in its licensed field to the renowned research on multiple myeloma performed at the University of Arkansas for Medical Sciences, in April 2010.

About LD Micro

LD Micro is an investment newsletter firm that focuses on finding undervalued companies in the micro-cap space. Since 2002, the firm has published reports on select companies throughout the year. The firm also hosts the LD Micro Main Event in December. It is a non-registered investment advisor. For more information, please contact 408-457-1042 or visit www.ldmicro.com.

Safe Harbor Statement

This press release contains “forward-looking” statements. Such statements can be identified by, among other things, the use of forward-looking language such as the words “may,” “will,” “expect,” “anticipate,” “estimate,” “project,” “would,” “could” or words with similar meaning or the negatives of these terms or by the discussion of strategy or intentions. The forward-looking statements in this release include statements regarding our ability to achieve profitability and to penetrate the market opportunity that we believe exists for our prognostic genetic test. Such forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to differ materially from those discussed here, such as our ability to obtain adequate coverage and reimbursement for our tests from third party payors, our ability to obtain necessary regulatory clearances and approvals, the ability of our tests to keep pace with rapid advances in technology, medicine and science, and our ability to execute our marketing strategy and gain acceptance in the market, along with those other risks and uncertainties detailed in our SEC filings, and involve assumptions, estimates, and uncertainties that reflect current internal projections, expectations or beliefs. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. All forward looking statements contained in this press release are qualified in their entirety by these cautionary statements and the risk factors described above. Furthermore, all such statements are made as of the date this release and we assume no obligation to update or revise these statements unless otherwise required by law.

CONTACT: INVESTOR CONTACT:
         The Ruth Group
         David Burke
         Tel: 646-536-7009
         dburke@theruthgroup.com
Wednesday, May 27th, 2015 Uncategorized Comments Off on (SGNL) to Present at the LD Micro Invitational Conference

(HYGS) & Alstom Agreement To Commercialize Hydrogen-Powered Commuter Trains in Europe

GLADBECK, Germany, May 27, 2015  — Hydrogenics Corporation (Nasdaq:HYGS) (TSX:HYG) (“Hydrogenics” or “the Company”), a leading developer and manufacturer of hydrogen generation and hydrogen-based power modules, today announced that it has signed a 10 year exclusive agreement to supply Alstom Transport with hydrogen fuel cell systems for Regional Commuter Trains in Europe. Alstom Transport is a unit of Alstom, a France-based global leader in power generation, transmission and rail infrastructure with sales of  €6.2 billion for the year ended March 31, 2015.

The agreement, valued at over €50 million, includes the supply of at least 200 engine systems along with service and maintenance as necessary over a 10 year period. Hydrogenics was selected by Alstom following a rigorous technical review process. The fuel cell systems, based on the Company’s Heavy-Duty HD series fuel cells, will be developed to meet European train compliance regulations. The first units are expected to be delivered in 2016 following prototype work slated for late 2015.

“The selection by Alstom Transport of our technology platform is a strong validation of our team and our products as the best fit for heavy duty propulsion applications,” said Joseph Cargnelli, CTO and co-founder of Hydrogenics. “Our proprietary, innovative technology allows our systems to operate at best-in-class efficiencies, without humidification or compressor systems, thus providing a compelling value proposition for our customers. Hydrogenics’ experience in the supply of large, reliable propulsion systems for challenging applications was an important consideration in Alstom’s decision.”

“We are clearly excited by what this agreement represents,” added Daryl Wilson, CEO of Hydrogenics. “Hydrogen is continuing to play an increasing role in mitigating the energy and pollution issues that fossil-fuel based transportation creates worldwide. The electrification of heavy duty transport leads to opportunities for efficient, clean hydrogen-based power solutions to play a critical role. Hydrogenics is pleased to work with industry leading and forward-thinking companies such as Alstom Transport.”

A promoter of sustainable mobility, Alstom Transport develops and markets the most complete range of systems, equipment and services in the railway sector. Alstom Transport manages entire transport systems, including trains, signaling, maintenance and modernization, infrastructure and offers integrated solutions.

About Hydrogenics

Hydrogenics Corporation (www.hydrogenics.com) is a globally recognized developer and provider of hydrogen generation and fuel cell products and services, serving the growing industrial and clean energy markets of today and tomorrow. Based in Mississauga, Ontario, Canada, Hydrogenics has operations in North America and Europe.

Forward-looking Statements

This release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, and under applicable Canadian securities law. These statements are based on management’s current expectations and actual results may differ from these forward-looking statements due to numerous factors, including: our inability to increase our revenues or raise additional funding to continue operations, execute our business plan, or to grow our business; inability to address a slow return to economic growth, and its impact on our business, results of operations and consolidated financial condition; our limited operating history; inability to implement our business strategy; fluctuations in our quarterly results; failure to maintain our customer base that generates the majority of our revenues; currency fluctuations; failure to maintain sufficient insurance coverage; changes in value of our goodwill; failure of a significant market to develop for our products; failure of hydrogen being readily available on a cost-effective basis; changes in government policies and regulations; failure of uniform codes and standards for hydrogen fuelled vehicles and related infrastructure to develop; liability for environmental damages resulting from our research, development or manufacturing operations; failure to compete with other developers and manufacturers of products in our industry; failure to compete with developers and manufacturers of traditional and alternative technologies; failure to develop partnerships with original equipment manufacturers, governments, systems integrators and other third parties; inability to obtain sufficient materials and components for our products from suppliers; failure to manage expansion of our operations; failure to manage foreign sales and operations; failure to recruit, train and retain key management personnel; inability to integrate acquisitions; failure to develop adequate manufacturing processes and capabilities; failure to complete the development of commercially viable products; failure to produce cost-competitive products; failure or delay in field testing of our products; failure to produce products free of defects or errors; inability to adapt to technological advances or new codes and standards; failure to protect our intellectual property; our involvement in intellectual property litigation; exposure to product liability claims; failure to meet rules regarding passive foreign investment companies; actions of our significant and principal shareholders; dilution as a result of significant issuances of our common shares and preferred shares; inability of US investors to enforce US civil liability judgments against us; volatility of our common share price; and dilution as a result of the exercise of options; and failure to meet continued listing requirements of Nasdaq. Readers should not place undue reliance on Hydrogenics’ forward-looking statements. Investors are encouraged to review the section captioned “Risk Factors” in Hydrogenics’ regulatory filings with the Canadian securities regulatory authorities and the US Securities and Exchange Commission for a more complete discussion of factors that could affect Hydrogenics’ future performance. Furthermore, the forward-looking statements contained herein are made as of the date of this release, and Hydrogenics undertakes no obligations to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release, unless otherwise required by law. The forward-looking statements contained in this release are expressly qualified by this.

CONTACT: For further information, contact:
         Bob Motz, Chief Financial Officer
         (905) 361-3660
         investors@hydrogenics.com

         Chris Witty
         Hydrogenics Investor Relations
         (646) 438-9385
         cwitty@darrowir.com
Wednesday, May 27th, 2015 Uncategorized Comments Off on (HYGS) & Alstom Agreement To Commercialize Hydrogen-Powered Commuter Trains in Europe

(SPHS) to Present at the LD Micro Invitational Conference

Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 for the treatment of urological diseases, today announced that Randall E. Woods, president and chief executive officer, will present a corporate overview at the LD Micro Invitational Conference. The presentation is scheduled for Tuesday, June 2, 2015 at 11:30 a.m. PDT in Los Angeles.

The presentation will be webcast live and can be accessed through the Investor Relations page at www.sophiris.com. A replay of the presentation will be available on the Company’s website for 90 days.

About Sophiris

Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of urological diseases. PRX302 is in Phase 3 clinical development for the treatment of the symptoms of BPH and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. PRX302 is also in a Phase 2a proof of concept trial for the treatment of localized low to intermediate risk prostate cancer. For more information, please visit www.sophiris.com.

Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Sophiris’ current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact:
Sophiris Bio Inc.
Peter Slover
Chief Financial Officer
(858) 777-1760
or
Corporate Communications and Investor Relations:
Equicom Group
Investor Relations
Michael Moore
858-886-7813
mmoore@tmxequicom.com
or
Canale Communications, Inc.
Corporate Communications and IR
Jason I. Spark
619-849-6005
jason@canalecomm.com

Wednesday, May 27th, 2015 Uncategorized Comments Off on (SPHS) to Present at the LD Micro Invitational Conference

(DCTH) Forum On CHEMOSAT Therapy Affirms Liver Cancer Benefits

NEW YORK, May 27, 2015  — Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces findings from its recent three-day Key Opinion Leader Forum that focused on CHEMOSAT®, the Company’s percutaneous hepatic perfusion (PHP) therapy for the treatment of liver cancers.  The Forum took place near Paris and included more than 20 medical specialists in oncology, surgical oncology, anesthesiology and interventional radiology from across Europe where CHEMOSAT is commercially available.  CHEMOSAT is not commercially available in the US.

The Forum featured a discussion of hands-on commercial experiences with CHEMOSAT. Key findings from the Forum were:

  • Clinicians continue to produce positive, life-extending results treating liver cancer patients with CHEMOSAT in multiple tumor types
  • CHEMOSAT is well tolerated and is an easy-to-learn procedure for an experienced treatment team
  • Multiple treatment courses of at least four procedures have been shown to be safe and well tolerated while continuing to provide clinical benefit and good quality of life
  • Reimbursement continues to be covered through individual funding requests
  • Clinicians are encouraged by the potential for CHEMOSAT to treat many tumor types and support the generation of additional data in these potential indications

“This 3-day forum on CHEMOSAT provided a unique opportunity for us to share our patient experiences from multiple treatment centers in Europe using CHEMOSAT to treat liver cancer patients.  The exchange of ideas and practices among a diverse field of leading clinicians in the various medical specialties that implement CHEMOSAT therapy was illuminating and compelling, especially given the meaningful clinical benefits it brings to patients.  The discussions were very valuable and have given me new perspectives on the implementation of CHEMOSAT for my liver cancer patients,” noted Prof. Arndt Vogel, M.D., Clinic of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Alex Vahrmeijer, M.D., Ph.D., a surgical oncologist at Leiden University Medical Centre, the Netherlands, commented, “Delcath’s CHEMOSAT is an effective new therapy for metastases confined to the liver for patients with very limited treatment options.  We have demonstrated the ability to perform repeat PHP procedures with CHEMOSAT that showed continued tolerability and significant clinical benefit for patients in this life-limiting cancer indication.  We believe this procedure has strong potential to treat a number of other tumor types and is worthy of further clinical investigation in those indications.”

“We were delighted to convene this Forum as it brought together clinicians from across Europe who are commercially using CHEMOSAT to share their treatment center’s patient experiences and to exchange ideas on optimizing the procedure and expanding the clinical benefits of CHEMOSAT in other tumor types,” stated Jennifer Simpson, Ph.D., President and Chief Executive Officer of Delcath.  “This Forum produced valuable data both for the commercialization of CHEMOSAT and for its expanded clinical development.  European clinicians who participated in the Forum are in the process of developing a white paper on their findings and recommendations.  We look forward to the publication of their report and expect it will further the awareness and understanding of the benefits of CHEMOSAT to treat liver cancers, while supporting continued adoption in key European markets.”

About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers. Our proprietary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure. In April 2012 we obtained authorization to affix a CE Mark to our second-generation system, which is currently marketed in Europe as a device under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the U.S. Food and Drug Administration (FDA). The Melphalan/HDS system has not been approved for sale in the U.S. We have commenced a global Phase 2 clinical trial in Europe and the U.S. to investigate the Melphalan/HDS system for the treatment of primary liver cancer (HCC), and expect to initiate a global Phase 3 trial in ocular melanoma (OM) that has metastasized to the liver and plan to evaluate intrahepatic cholangiocarcinoma (ICC) in a Phase 2 clinical study.

Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: timely patient enrollment the ability to complete an interim evaluation of the Company’s Global Phase 2 HCC program, acceptance and publication of the Phase 3 trial manuscript and the impact of publication to support the Company’s efforts,  the timing and results of the Company’s  clinical trials including without limitation the HCC, ICC  and OM  clinical trial programs  timely enrollment and treatment of patients in the global Phase 2 HCC and ICC clinical trial, FDA approval of the global Phase 3 OM clinical trial protocol, IRB or ethics committee clearance of the Phase 2 HCC/ICC  and/or Phase 3 OM  protocols from  participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at ESSO and future clinical results consistent with the data presented, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any  of Value 4 status on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets, the Company’s ability to satisfy the requirements of the FDA’s Complete Response Letter and provide the same in a timely manner, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Contact Information:

Investor Contact:

LHA

Anne Marie Fields,

afields@lhai.com

212-838-3777

Wednesday, May 27th, 2015 Uncategorized Comments Off on (DCTH) Forum On CHEMOSAT Therapy Affirms Liver Cancer Benefits

(CERE) Awarded Patent for Innovation in Soybean

THOUSAND OAKS, Calif., May 27, 2015  — Ceres, Inc. (Nasdaq: CERE), an agricultural biotechnology company, has been awarded a U.S. patent for a genetic sequence derived from soybean, covering uses of the gene in areas such as research, product development and plant transformation. The company believes that its gene is useful in regulating key biosynthetic processes that are the target of a class of commercial herbicides. Ceres plans to offer other seed companies a commercial license to the innovation, including an opportunity for exclusivity in certain crops.

Richard Hamilton, President and CEO of Ceres, said that the company is currently evaluating the potential market for this gene among soybean seed companies and the use of its patented invention in the development and production of improved soybean varieties.

Ceres’ biotechnology platform, which has proven to increase crop productivity, raise quality, reduce crop inputs and improve cultivation on marginal land, has broad application across multiple markets and crops.

Hamilton noted that growers are facing increasing demand for food, feed, fiber and fuel as a result of rising global population and an expanding middle class in certain regions. “The need for technology improvements has become more pressing due to stresses from climate variability and competition for water resources,” said Hamilton. “Agricultural biotechnology has and will continue to represent a significant source of innovation for increasing crop yields through improving performance of seeds.”

The new patent for this invention was issued by the U.S. Patent and Trademark Office as U.S. Patent No. 9,024,004 and is titled, Sequence-Determined DNA Fragments Encoding Acetohydroxyacid Synthase Proteins. Ceres owns or maintains exclusive licensed rights to approximately 85 issued patents and numerous pending patent applications in the United States and in various foreign jurisdictions. A patent is an intellectual property right granted by a government to an inventor to exclude others from making, using, offering for sale, or selling the invention for a limited time in exchange for public disclosure of the invention when the patent is granted.

Soybean is one of the most valuable and widely planted row crops in the world. From 2003 to 2013, the number of acres planted increased 2.4% annually, to 275 million acres today, according to the Food and Agriculture Organization of the United Nations. Soybeans are used for oil, feed for livestock and aquaculture, as a biofuel feedstock and as a protein for the human diet.

About Ceres
Ceres, Inc. is an agricultural biotechnology company that develops and markets seeds to produce crops for forage, biofuels and other markets that utilize plant biomass. The company’s advanced plant breeding and biotechnology technology platforms, which can increase crop productivity, improve quality, reduce crop inputs and improve cultivation on marginal land, have broad application across multiple crops, including food, feed, fiber and fuel crops. Ceres markets its seed products under its Blade brand. The company also licenses its biotech traits and technology, including its Persephone genome visualization software, to other life science companies and organizations.

Ceres Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, including statements regarding Ceres’ efforts to develop and commercialize its products and technologies, anticipated yields and product performance, status of crop plantings, short-term and long-term business strategies, market and industry expectations, future operating metrics, and future results of operations and financial position, including anticipated cost savings from the company’s plan to align expenditures and projected cash expenditures, are forward-looking statements. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Ceres’ control. Factors that could materially affect actual results can be found in Ceres’ filings with the U.S. Securities and Exchange Commission. Ceres undertakes no obligation to update publicly, except to the extent required by law, any forward-looking statements for any reason after the date the company issues this press release to conform these statements to actual results or to changes in the company’s expectations.

Wednesday, May 27th, 2015 Uncategorized Comments Off on (CERE) Awarded Patent for Innovation in Soybean

(IPCI) FDA Grants Fast Track Designation To Rexista(TM)

TORONTO, May 26, 2015  — Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration (“FDA”) has reviewed the Company’s request for Fast Track designation for its abuse deterrent Rexista™ Oxycodone XR (Oxycodone HCl) extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System (“PODRAS“) and has concluded that it meets the criteria for Fast Track designation.

Fast Track is a designation assigned by the FDA in response to an applicant’s request which meets FDA criteria. The designation mandates the FDA to facilitate the development and expedite the review of drugs intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. This could potentially result in accelerated approval for Rexista™ Oxycodone XR thereby making it available to patients earlier than would be traditionally possible.

In March 2015, the Company requested Fast Track designation for its novel, and potentially first-in-class, Rexista™ Oxycodone XR abuse deterrent oxycodone hydrochloride extended release tablets incorporating its PODRAS technology platform. A basis for the request was that Rexista™ Oxycodone XR has the potential to address an unmet medical need, namely the prevention, deterrence or reduction of the abuse of oxycodone HCl extended release solid oral dosage forms involving the deliberate or inadvertent oral ingestion of more intact pills or tablets than prescribed to achieve a feeling of euphoria. This is a very common and serious form of drug abuse.

Rexista™ Oxycodone XR is intended for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Such medications are considered important in the treatment of chronic pain, but have the potential for abuse.

We are pleased with the grant by the FDA of Fast Track status for Rexista™ Oxycodone XR incorporating our proprietary PODRAS™ technology which is being formulated to decrease the ‘liking’ of dose escalation and decrease or delay the attendant risk of respiratory depression in drug-naive individuals. The development of this product candidate could, if successful, decrease the desirability of taking more intact tablets than prescribed, potentially addressing an unmet need and possibly resulting in fewer accidental or intentional deaths,” stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. “To the best of our knowledge, no other product currently approved for sale in the U.S. or Canada has demonstrated this potential.”

There can be no assurance that the Company will, as a result of the Fast Track designation for Rexista™ Oxycodone XR, experience a faster development process or review, compared to conventional FDA standards, or that the Company’s Rexista™ Oxycodone XR product candidate will be approved at all, or that it will ever be successfully commercialized.

About Rexista™ Oxycodone XR incorporating PODRAS™

The Company’s Rexista™ Oxycodone XR product candidate has been further enhanced with its proprietary PODRAS™ delivery technology intended to reduce the likelihood of oral abuse when more pills than prescribed are swallowed intact. Preclinical studies of Rexista™ Oxycodone XR suggest that if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected.

Details on the FDA Fast Track program can be found in the link below:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122932.htm

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths which received final FDA approval) and product candidates in various stages of development, including Abbreviated New Drug Applications filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

Intellipharmaceutics also has New Drug Application 505(b)(2) product candidates in its development pipeline. These include Rexista™ Oxycodone XR, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and PODRAS™ Paradoxical OverDose Resistance Activating System, and Regabatin™ XR pregabalin extended-release capsules.

Certain statements in this document constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or “forward-looking information” under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” “intends,” “could,” or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing and the expected use of any proceeds from any offering of our securities, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the difficulty of predicting the impact of competitive products and pricing and the timing and success of product launches, the inability to forecast wholesaler demand and/or wholesaler buying patterns, the seasonal fluctuation in the numbers of prescriptions written for our dexmethylphenidate hydrochloride extended-release capsules which may produce substantial fluctuations in revenues, the timing and amount of insurance reimbursement for our products, changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, difficulties or delays in manufacturing, the manufacturing capacity of third-party manufacturers that we may use for our products, and the successful compliance with FDA, Health Canada and other governmental regulations applicable to the Company and its third party manufacturers’ facilities, products and/or businesses. Additional risks and uncertainties relating to the Company and our business can be found in the “Risk Factors” section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Company Contact:
         Intellipharmaceutics International Inc.
         Domenic Della Penna
         Chief Financial Officer
         416-798-3001 ext 106
         investors@intellipharmaceutics.com

         Investor Contact:
         ProActive Capital
         Kirin Smith
         646-863-6519
         ksmith@proactivecapital.com
Tuesday, May 26th, 2015 Uncategorized Comments Off on (IPCI) FDA Grants Fast Track Designation To Rexista(TM)

(SGRP) Announces Industry’s First Seamless Global RSO System

SPARtrac(TM) System Enables More Comprehensive Automated Management of Retail Services

WHITE PLAINS, N.Y., May 26, 2015  — SPAR Group, Inc. (Nasdaq:SGRP) (“we”, the “Company” or “SPAR”), a leading global supplier of retail merchandising and other marketing services, today announced the launch of its SPARtrac™ Global Retail Service Operations System. The enhanced system, culminating years of research, development and testing, has been designed to provide retailers and manufacturers the most comprehensive set of tools for more efficiently managing retail services including general merchandising, demonstrations, promotional events, sales assist, audits and assembly.

Panos Mastrogiannis, SPAR Group’s Chief Information Officer, commented, “Our global, Fortune 1000 Clients are actively seeking more efficient customized solutions to manage increasingly complex merchandising and compliance needs across their global retail locations.  SPARtrac seamlessly manages everything from job initiation to reporting while also providing unlimited data collection capabilities in real-time, worldwide. We routinely collect more than 1000 data points in a single store visit. Competitive systems only collect a fraction of that amount.”

By providing more operational visibility and control, SPARtrac provides a clearer picture of what is happening on the sales floor and speeds up reaction times to maximize product movement, while optimizing field efficiencies at the same time. The combination of more visibility, speed, control, accuracy and efficiency in moving product through the store leads to more sales and profits. A few specific key benefits include:

  • More than 170 applications for automated management and visibility of everything from personnel and workflow management to data collection and reporting to issue tracking and resolution. Most competitor systems manage only a handful of applications.
  • Unlimited data point collection.  Most collect only a few.
  • Uninterrupted data collection with no connectivity needed. With most others, merchandisers need to find data connection to collect store data, slowing the work down considerably.
  • Multi-lingual capabilities that seamlessly connect multiple countries around the world, thus improving the visibility and management of international operations.
  • Adaptive technology: SPARtrac integrates with client systems, is customizable to solve specific client needs, and incorporates the latest technologies and tools from across the globe, including image recognition software for more efficient auditing.
  • Workflow management and data reporting by country, district, retailer, state, store, fixture, UPC, merchandiser and more.
  • Six Sigma reliability levels with 24/7/365 tech support worldwide.

The SPARtrac Global Retail Service Operations System is fully operational now for use by all SPAR Clients. Its launch coincides with a re-launch of SPAR’s website, which includes a portal for clients to log into the SPARtrac system and access real-time data to aid in making critical business decisions quickly. The new dashboard allows Clients to quickly see topline results and identify trends with graph and chart summaries, view an execution heat map to see where store visits are scheduled, completed and pictures have been taken, access the SPAReyes Photo/Video Manager, track issues, and drill down to specific data of interest to them with a quick click. Clients can also access all data wherever they are using the system’s SPAR On The Go mobile app.

Both the new SPARtrac Global Retail Service Operations System and the message throughout the new website reinforce SPAR’s focus on the end result of what it helps its clients do: Get more out of the store™. SVP Marketing Dave Musiel stated, “The primary focus of many of our competitors is on selling product into the store. At SPAR, we maximize our Clients’ results by thinking differently. It’s not about how much product gets in the store. It’s about how much gets out. Our job, and the job of our technology, is to optimize the sell-through as quickly, efficiently and informatively as possible.”

About SPAR Group

SPAR Group, Inc. is a diversified international merchandising and marketing services Company and provides a broad array of services worldwide to help companies improve their sales, operating efficiency and profits at retail locations. The Company provides merchandising and other marketing services to manufacturers, distributors and retailers worldwide, primarily in mass merchandiser, office supply, value, grocery, drug, independent, convenience, toy, home improvement and electronics stores, as well as providing furniture and other product assembly services, audit services, in-store events, technology services and marketing research. The Company has supplied these project and product services in the United States since certain of its predecessors were formed in 1979 and internationally since the Company acquired its first international subsidiary in Japan in May of 2001. Product services include restocking and adding new products, removing spoiled or outdated products, resetting categories “on the shelf” in accordance with client or store schematics, confirming and replacing shelf tags, setting new sale or promotional product displays and advertising, replenishing kiosks, providing in-store event staffing and providing assembly services in stores, homes and offices. Audit services include price audits, point of sale audits, out of stock audits, intercept surveys and planogram audits. Other merchandising services include whole store or departmental product sets or resets (including new store openings), new product launches, in-store demonstrations, special seasonal or promotional merchandising, focused product support and product recalls. The Company currently does business in 9 countries that encompass approximately 50% of the total world population through its operations in the United States, Canada, Japan, South Africa, India, China, Australia, Mexico and Turkey. For more information, please visit the SPAR Group’s website at http://www.sparinc.com.

Forward-Looking Statements

Certain statements in this news release are forward-looking, including (without limitation) any expectations, guidance or other information respecting the Company’s establishing or strengthening any retail partner relationship with our clients, our collection or analysis of retail data or its value, our provision of insights to our clients, whether such insights will lead to our clients’ competitive advantage, whether such insights will lead to our clients’ better understanding retail trends, whether a better understanding of such insights and retail trends will lead to our clients’ leveraging them to further their in-store sales objectives, our development of new or improved ways to use technology in-store, finding the best, brightest and most experienced professionals to join us, the Company’s five corporate objectives (growth, customer value, employee development, productivity & efficiency, and earnings per share), building upon and investing in further innovations to strengthening the Company’s strong foundation and business, leveraging compatible global opportunities, improving on the value we already deliver to clients, growing our client base, customer contract expansion, continuing to strengthen our balance sheet strength,, growing revenues and becoming profitable through organic growth and acquisitions, attracting new business that will increase SPAR Group’s revenues, improving product mix, continuing to maintain or reduce costs and consummating any transactions. You should not place undue reliance on the Company’s forward-looking statements and similar information because they are based on the Company’s plans, intentions, expectations and estimates (although it believes them to be reasonable) and involve known and unknown risks, uncertainties and other unpredictable factors (many of which are beyond the Company’s control) that could cause them to fail to occur or be realized or to be materially and adversely different from those the Company planned, intended, expected or estimated.

You should carefully review the risk factors described in the Company’s most recent Annual Report (See Item 1A – Risk Factors) and any other risks, cautions or information contained or incorporated by reference into the Company’s most recent Annual Report or more recent Quarterly and Current Reports as filed with the Securities and Exchange Commission (each a “SEC Report”). The Company’s forward-looking statements, risk factors and other risks, cautions and information (whether contained in this news release, the update conference call referenced above or any applicable SEC Report) are based on the information then available to the Company and speak only as of the applicable date. New risks and uncertainties arise from time to time, and it is impossible for the Company to predict these matters or how they may arise or affect the Company. Over time, the Company’s actual assets, business, capital, cash flow, credit, expenses, financial condition, income, liabilities, liquidity, locations, marketing, operations, performance, prospects, sales, strategies, taxation or other achievements, results, risks, trends or condition will likely differ from those expressed or implied by the Company’s forward-looking statements, and such difference could be significant and materially adverse to the Company and the value of your investment in the Company’s Common Stock. The Company does not intend or promise to publicly update or revise any forward-looking statements, risk factors or other risks, cautions or information (in whole or in part), whether as a result of new information, risks or uncertainties, future events or recognition or otherwise, except as and to the extent required by applicable law.

All of the Company’s forward-looking statements and other information contained in this news release or presented during the update conference call referenced above are expressly qualified by all such risk factors and other risks, cautions and information contained or referenced in each of the Company’s applicable SEC Reports.

CONTACT: For more information, contact:

         Panos Mastrogiannis
         Chief Information Officer
         (914) 332-4100
         panosm@sparinc.com
Tuesday, May 26th, 2015 Uncategorized Comments Off on (SGRP) Announces Industry’s First Seamless Global RSO System

(XBIT) Successfully Clones First Anti-Ebola Therapeutic Antibody Product Candidate

AUSTIN, Texas, May 26, 2015  — XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announced today that it has successfully isolated and cloned an anti-Ebola product candidate using its True Human antibody discovery platform.

True Human antibodies are derived directly from human donors that have natural immunity to disease. The anti-Ebola product candidate was developed from a blood donation received earlier this year from a patient who recovered from Ebola infection.

John Simard, President and CEO of XBiotech, stated, “Our response to the Ebola outbreak has been a very special project in several ways. Our technology offered us the ability to develop a curative therapy to a deadly disease that was ravaging nations and even threatened us here at home; and it offered the potential to develop a therapy with unparalleled speed. What started with selfless donations from Ebola survivors only a few months ago has resulted in a True Human antibody therapeutic candidate that could be used to treat the disease. We are very proud of the capabilities we have developed and are humbled by the potential to address serious unmet medical need at home and abroad.”

Simard continued, “Additionally, the results of our Ebola program further represent how XBiotech’s core strength in efficient drug discovery makes the company uniquely capable to quickly respond to disease outbreaks.”

About XBiotech

XBiotech is pioneering a new era in the discovery and development of targeted antibodies based on its True HumanTM technology. The company’s mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of truly natural human antibodies for treating serious diseases such as cancer, inflammatory conditions and infectious diseases. XBiotech’s lead product, Xilonix™, is a potential breakthrough antibody therapy that is currently the subject of two pivotal clinical studies for treating patients with advanced colorectal cancer. Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis, growth and spread of tumors, as well as mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer. XBiotech’s broad pipeline of True Human antibodies are able to potentially deliver unmatched safety and efficacy because they are cloned directly from individual donors who possess natural immunity against certain targeted diseases. As such, True Human antibodies retain their natural physiology and tolerance profile, having passed the rigors of immune selection in the body. For more information, visit www.xbiotech.com.

CONTACT: Ashley Otero
         XBiotech
         aotero@xbiotech.com
         512.386.2930

         Tiberend Strategic Advisors, Inc.:

         Joshua Drumm, Ph.D. (investors)
         jdrumm@tiberend.com
         212.375.2664

         Janine McCargo (media)
         jmccargo@tiberend.com
         646.604.5150
Tuesday, May 26th, 2015 Uncategorized Comments Off on (XBIT) Successfully Clones First Anti-Ebola Therapeutic Antibody Product Candidate

(FPRX) & (BLUE) Enter into License Agreement for T Cell Therapy Novel Antibodies

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., May 26, 2015  — bluebird bio, Inc. (Nasdaq:BLUE) and Five Prime Therapeutics, Inc. (Nasdaq:FPRX) today announced that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using Five Prime’s proprietary human antibodies to an undisclosed cancer target for hematologic malignancies and solid tumors.

Under the terms of the agreement, Five Prime will provide bluebird bio exclusive rights to its novel human antibodies to the target, and bluebird bio will leverage its proprietary lentiviral gene therapy platform and CAR T capabilities to develop CAR T therapies against the target. Financial terms of the agreement include a $1.5 million upfront payment and subsequent milestone payments to Five Prime, which together could total over $130 million per licensed product if certain development, regulatory, and commercial milestones are achieved. Five Prime is also eligible to receive tiered royalties on product sales. bluebird bio will conduct and fund clinical development as well as regulatory and commercial activities.

“CAR T cell therapies have emerged as a very promising approach for treating a number of cancers,” said Lewis “Rusty” T. Williams, M.D., Ph.D., chief executive officer & president of Five Prime. “bluebird bio brings a wealth of knowledge in the area of gene therapy, a key component of building CAR T therapeutics. We are also impressed by bluebird bio’s development and manufacturing infrastructure. We feel that bluebird bio is well positioned to succeed with converting Five Prime’s human antibodies to CAR T cell products that can benefit patients, and we are pleased that our proprietary platform continues to demonstrate its versatility in the field of immuno-oncology.”

“We are very pleased to enter into this agreement with Five Prime, a company with a track record of success in the characterization and development of therapeutic antibodies to extracellular proteins,” said Jeffrey T. Walsh, chief operating officer of bluebird bio. “Five Prime’s program offers a strategic fit to our research and will augment bluebird bio’s growing pipeline of immuno-oncology research and preclinical programs.”

About bluebird bio, Inc.

With its lentiviral-based gene therapy and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. bluebird bio’s clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). bluebird bio also has a preclinical CAR T cancer immuno-oncology program in collaboration with Celgene Corporation, as well as discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies.

bluebird bio has operations in Cambridge, Massachusetts, Seattle, Washington, and Paris, France. For more information, please visit www.bluebirdbio.com.

About Five Prime Therapeutics

Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime’s comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company’s R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.

bluebird bio Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the research, development and advancement of bluebird bio’s product candidates and CAR T research program.  Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that bluebird bio’s CAR-T research program for this target will be unsuccessful and not identify any viable product candidates, the risk of cessation or delay of any planned clinical studies and/or our development of our product candidates, the risk that our collaboration with Celgene will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

Five Prime Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Five Prime’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding Five Prime’s potential receipt of upfront and milestone payments and royalties. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Five Prime’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Five Prime assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

CONTACT: bluebird bio, Inc.
         bluebird bio Investor Relations:
         Manisha Pai, 617-245-2107
         mpai@bluebirdbio.com
         or
         Media Contact:
         Pure Communications, Inc.
         Dan Budwick, 973-271-6085

         Five Prime Therapeutics, Inc.
         Amy Kendall, 415-365-5776
         amy.kendall@fiveprime.com
Tuesday, May 26th, 2015 Uncategorized Comments Off on (FPRX) & (BLUE) Enter into License Agreement for T Cell Therapy Novel Antibodies

(ATNM) Key Opinion Leaders Highlight Iomab-B’s Future in Bone Marrow Transplant

Hillard Lazarus, MD, Pioneer Transplanter and Roland Turck, MD, Radiopharmaceutical Commercialization Veteran Detailed Unmet Medical Need and Development Path for Iomab-B

NEW YORK, NY–(May 26, 2015) – Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, recently hosted a Key Opinion Leader (KOL) Breakfast for healthcare investors and industry professionals at the NY Palace Hotel. A complete video of this event, as well as brief highlights from the presentations are available and posted for viewing at http://www.actiniumpharma.com/investors/media-content/.

The panelists discussed the dire need for new therapies for older patients with hematologic malignancies including acute myeloid leukemia (AML), and the curative role of bone marrow transplant. Iomab-B was described as having efficacy and safety superior to that of traditional myeloablative regimens, and likely to markedly increase the number of patients eligible for transplant. An update on the upcoming Phase 3 clinical trial of Iomab-B, plus clinical positioning and positive commercial prospects were also provided, and can be viewed online.

The meeting featured bone marrow transplant and hematology specialist Hillard M. Lazarus, MD, a Professor of Medicine at Case Western Reserve University (CWRU) School of Medicine, as well as Disease Team Leader and Director of Novel Cell Therapy at University Hospitals, Case Medical Center, and Company Scientific Advisory Board Member. Also featured was radiopharmaceutical industry veteran Roland U. Turck, MD, Managing Partner at TurckBio and recently-appointed Senior Advisor to the Actinium Board of Directors. Dr. Turck has extensive, unparalleled experience in the launch and commercialization of radiopharmaceuticals.

Dr. Lazarus performed the first bone marrow transplant in Ohio in 1976, and has had a seminal impact on multiple aspects of transplantation He now heads several clinical trials at the National Center for Regenerative Medicine (CWRU). He has over 500 publications and has won a variety of lifetime achievement, distinguished alumnus, and cancer research awards, in addition to fellowships sponsored by the Leukemia Society of America and the American Cancer Society.

Dr. Turck was formerly the head of Bayer’s Global Specialty Medicine business, where he helped lead the commercialization of Xofigo, the first alpha particle-emitting radioactive agent, whose launch has been the most commercially successful of any radiopharmaceutical product to date. He is an expert in biopharmaceutical specialty medicine with more than 20 years of pharmaceutical industry experience at Bayer, Berlex, and Schering, having developed and commercialized several major oncology products on a global scale, including Xofigo, Stivarga, Nexavar, and Campath.

Those interested in learning more about Iomab-B or bone marrow transplantation are encouraged to view filmed highlights, or the full-length video of the presentations, which are available in the media section of the Company’s website, at http://www.actiniumpharma.com/investors/media-content/.

About Bone Marrow Transplant:
Bone marrow transplants (BMT) are most commonly used to treat leukemia and lymphoma, conditions incurred when a blood or immune cell, respectively, becomes cancerous and proliferates. Together, these diseases account for some 50,000 to 75,000 new cases annually in the United States. BMT involves first clearing a patient’s body of his or her own immune cells and then transplanting bone marrow, the source of all blood- and immune-forming cells, from a tissue-matched donor. The new cells, which are free of cancer, repopulate the patient’s bone marrow and eventually give rise to a functioning set of blood and immune cells, providing a lifelong cure. BMT offers the chance of a “curative” outcome (2+ year survival), and therefore can play a central role in the treatment of AML. The impact of BMT on AML continues to increase with AML being the most common and fastest growing indication for allogeneic BMT, comprising 25% to 30% of all BMT recipients. There are currently over 100,000 BMT survivors across all indications and this number is expected to increase to 250,000 by 2020 and 500,000 by 2030, with 25% of them over age 60.

About Iomab-B
Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM).

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company’s second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Contact:
David Gould, MD
SVP, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
dgould@actiniumpharma.com

Tuesday, May 26th, 2015 Uncategorized Comments Off on (ATNM) Key Opinion Leaders Highlight Iomab-B’s Future in Bone Marrow Transplant

(GKNT), ThinkGeek Parent, To Be Acquired By Hot Topic

LOS ANGELES and FAIRFAX, Va., May 26, 2015  — Hot Topic, Inc. (“Hot Topic”), a leading mall and web-based specialty retailer, and Geeknet, Inc. (Nasdaq: GKNT, “Geeknet”), the parent company of online retailers ThinkGeek and ThinkGeek Solutions, today announced that they have entered into a definitive agreement under which Hot Topic will acquire all of the outstanding shares of Geeknet, Inc. common stock at a purchase price of $17.50 per share.  The transaction will be completed by means of a tender offer to be commenced shortly.  The transaction has a total equity value of approximately $122 million, including $37 million of cash and cash equivalents as of March 31, 2015.

“We are pleased to have entered into this agreement and look forward to adding Geeknet’s innovative products and services to our portfolio,” said Lisa Harper, Chief Executive Officer of Hot Topic. “Geeknet’s unique concept and approach to the online retail community is a strong fit with our business strategy, which is focused on delivering great products for avid fans of various licensed properties, and we are excited about the opportunity to help drive profitable growth and further enhance value for Geeknet’s customers.”

“Our Board and management team believe this transaction is in the best interest of the Company and its stockholders,” said Kathryn McCarthy, Chief Executive Officer of Geeknet. “We remain focused on increasing our visibility, providing a platform to stimulate ideas and creativity, and expanding our product offerings to keep up with industry and customer demands. As a subsidiary of Hot Topic, Geeknet will be well-positioned to achieve these goals.”

Pursuant to the agreement, the tender offer will commence no later than June 19, 2015. Consummation of the tender offer is subject to certain customary conditions. Shareholders representing approximately 21% of Geeknet outstanding shares have committed to participate in the tender offer.

Guggenheim Securities served as Geeknet’s exclusive financial advisor and Wachtell, Lipton, Rosen & Katz served as its legal advisor.  Kirkland & Ellis LLP and the Law Offices of Gary M. Holihan, PC served as legal advisors to Hot Topic.

About Hot Topic, Inc.
Hot Topic, Inc. is a leading mall and web-based specialty retailer offering music/pop culture licensed and influenced apparel and accessories. The company operates more than 650 stores in the U.S. and Canada. Based in Los Angeles, CA, Hot Topic, Inc. is a portfolio company of Sycamore Partners, a private equity firm based in New York specializing in retail and consumer investments.

About Geeknet, Inc.
Geeknet, Inc. (NASDAQ: GKNT) is the parent company of ThinkGeek and ThinkGeek Solutions.  ThinkGeek is the premier retailer for the global geek community.  Since 1999, ThinkGeek has been creating a world where everyone can express their inner geek, embrace their passions, and connect with each other.  ThinkGeek Solutions, which distributes video game-themed merchandise through licensed web-stores for the gaming community, joined our Geeknet family in August 2014.  Our obsession is creating and sharing unique and authentic product experiences that stimulate our fans’ imaginations and fuel their geek core.  We believe that there is a geek in everyone and that it should be celebrated.  Want to learn more?  Check out thinkgeek.com or geek.net.

Additional Information
The tender offer for the outstanding common stock of Geeknet, Inc. (“Geeknet”) referred to in this communication has not yet commenced.  This communication is not an offer to purchase or a solicitation of an offer to sell shares of Geeknet’s common stock.  The solicitation and the offer to purchase shares of Geeknet’s common stock will only be made pursuant to an offer to purchase and related materials that Hot Topic and Gadget Merger Sub Inc., a wholly owned subsidiary of Hot Topic (“Acquisition Sub”), intend to file with the Securities and Exchange Commission (the “SEC”).  At the time the tender offer is commenced, Hot Topic and Acquisition Sub will file a Tender Offer Statement on Schedule TO with the SEC, and soon thereafter Geeknet will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer.  GEEKNET STOCKHOLDERS ARE ADVISED TO READ THE SCHEDULE TO (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE, BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.  The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Geeknet at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov.

Forward-Looking Statements
This release contains forward-looking statements regarding, among other things, statements related to expectations, goals, plans, objectives and future events.  Geeknet intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “outlook,” “guidance” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.  The forward-looking information and statements are or may be based on a series of projections and estimates and involve risks and uncertainties.  Various factors could adversely affect Geeknet’s operations, business or financial results in the future and cause its actual results to differ materially from those contained in the forward-looking statements, including those factors discussed in detail in the “Risk Factors” sections contained in Geeknet’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 23, 2015 and in Geeknet’s subsequently filed Form 10-Q, as well as, among other things: (1) the ability to obtain requisite regulatory approvals required to complete the proposed transaction with Hot Topic, (2) the satisfaction of the conditions to the consummation of the proposed transaction, (3) the timing of the completion of the proposed transaction and (4) the potential impact of the announcement or consummation of the proposed transaction on Geeknet’s relationships, including with employees, suppliers and customer.  Given these uncertainties, undue reliance should not be placed on these forward-looking statements.  Geeknet does not undertake any obligation to release any revisions to these forward-looking statements publicly to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Tuesday, May 26th, 2015 Uncategorized Comments Off on (GKNT), ThinkGeek Parent, To Be Acquired By Hot Topic