Archive for February, 2017

$LIFE FDA ODD Limb Girdle Muscular Dystrophy with Resolaris

SAN DIEGO, Feb. 28, 2017  — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaris™ was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy (LGMD) patients.

“Receiving Orphan Drug Designation for the treatment of all types of LGMD patients with Resolaris is an important step in our overall process of bringing our first Physiocrine-based product candidate to the market to treat patients,” said John Mendlein, CEO of aTyr Pharma. “This designation follows our recently granted Fast Track designation and our promising signals of clinical activity in a LGMD sub-type (LGMD2B). We are excited to continue the development of Resolaris to treat patients with rare myopathies with an immune component who currently have limited or no therapeutic treatment options.”

The FDA’s Orphan Drug Designation program is intended to advance the development of products which demonstrate promise in diagnosing or treating rare conditions that affect fewer than 200,000 people in the U.S. Sponsors developing orphan-designated products are eligible for incentives under the program, including seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and certain tax credits.

About Resolaris™

aTyr Pharma is developing Resolaris as a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells. aTyr believes Resolaris has the potential to provide therapeutic benefit to patients with rare myopathies with an immune component characterized by excessive immune cell involvement.

About LGMD2B

Limb girdle muscular dystrophy (LGMD) refers to a group of rare genetic myopathies, of which there are more than 20 different subtypes, none with approved therapies. LGMD affects an estimated 16,000 patients in the U.S., approximately 3,000 of whom have LGMD2B. LGMD2B is a recessive genetic disease caused by a toxic loss of function in the dysferlin gene. Patients experience progressive debilitating muscle weakness and atrophy as well as immune cell invasion in the skeletal muscle. To learn more about LGMD2B please visit www.jain-foundation.org.

About aTyr Pharma

aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients suffering from severe, rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators. The Company’s lead candidate, Resolaris™, is a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. aTyr has built an intellectual property estate, to protect its pipeline, comprising over 80 issued or allowed patents and over 230 pending patent applications that are owned or exclusively licensed by aTyr, including over 300 potential Physiocrine-based protein compositions. aTyr’s key programs are currently focused on severe, rare diseases characterized by immune dysregulation for which there are currently limited or no treatment options. For more information, please visit http://www.atyrpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act.  Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the potential of Resolaris, the ability of the Company to undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals, and the timing of initiation of additional clinical trials and of reporting results from our clinical trials reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the discovery, development and regulation of our Physiocrine-based product candidates, as well as those set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2015 and in our subsequent SEC filings including our most recent Quarterly Report for the quarter ended September 30, 2016. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Mark Johnson
Sr. Director, Investor Relations
mjohnson@atyrpharma.com
858-223-1163

Tuesday, February 28th, 2017 Uncategorized Comments Off on $LIFE FDA ODD Limb Girdle Muscular Dystrophy with Resolaris

$CRSP Appointment of Jon Terrett, Ph.D., Head of Immuno-Oncology Research and Translation

  • Experienced leader with extensive experience in immuno-oncology
  • Dedicated unit in immuno-oncology to accelerate efforts

BASEL, Switzerland and CAMBRIDGE, Mass., Feb. 28, 2017  — CRISPR Therapeutics (NASDAQ:CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced the appointment of Jon Terrett, Ph.D. as Head of Immuno-Oncology Research and Translation.  Dr. Terrett brings to CRISPR Therapeutics an impressive track record for discovering and progressing a number of immuno-oncology drug candidates into the clinic.

“We are thrilled to have Dr. Terrett join CRISPR to head up our immuno-oncology efforts,” commented Rodger Novak, CEO of CRISPR Therapeutics. “Given the potential of CRISPR/Cas9 gene editing in immuno-oncology, we have created a dedicated unit to accelerate our discovery and development efforts.  We are excited about our progress to date and with the leadership of Dr. Terrett, we look forward to rapidly advancing our lead pre-clinical candidates to the clinic.”

Prior to joining CRISPR Therapeutics, Dr. Terrett was the Vice President of oncology discovery for CytomX, a U.S.-based biotechnology company focused on developing drugs to treat different types of cancer. In addition, Dr. Terrett has held various R&D leadership roles in biopharma, including serving as the Chief Scientific Officer at Oxford Biotherapeutics, and as a director at various biotechnology companies including Medarex, CellTech and Oxford Glycosciences.  Dr. Terrett earned a B.S. in genetics at the University of Sheffield and a doctorate in genetics at the University of Nottingham.

About CRISPR Therapeutics
CRISPR Therapeutics is a leading gene-editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR / Cas9 gene-editing platform. CRISPR / Cas9 is a revolutionary technology that allows for precise, directed changes to genomic DNA. The company’s multi-disciplinary team of world-class researchers and drug developers is working to translate this technology into breakthrough human therapeutics in a number of serious diseases. Additionally, CRISPR Therapeutics has established strategic collaborations with Bayer AG and Vertex Pharmaceuticals to develop CRISPR-based therapeutics in diseases with high unmet need. The foundational CRISPR / Cas9 patent estate for human therapeutic use was licensed from the company’s scientific founder Emmanuelle Charpentier, Ph.D. CRISPR Therapeutics is headquartered in Basel, Switzerland with its R&D operations based in Cambridge, Massachusetts. For more information, please visit www.crisprtx.com.

CRISPR Forward-Looking Statement
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the therapeutic value, development, the commercial potential of CRISPR/Cas-9 gene editing technologies and therapies and the intellectual property protection of our technology and therapies, and our ability to fund operating expenses and capital expenditures from existing cash resources. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: uncertainties regarding the intellectual property protection for our technology and intellectual property belonging to third parties; uncertainties inherent in the initiation and conduct of preclinical and clinical studies for the company’s product candidates; availability and timing of results from preclinical and clinical studies; whether results from a preclinical study or clinical trial will be predictive of future results in connection with future trials or use; expectations for regulatory approvals to conduct trials or to market products; and those risks and uncertainties described in Item 1A under the heading “Risk Factors” in the company’s most recent quarterly report on Form 10-Q, and in any other subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. The information contained in this press release is provided by the company as of the date hereof, and, except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking information contained in this press release.

 

MEDIA CONTACTS:
Jennifer Paganelli
W2O Group for CRISPR
347-658-8290
jpaganelli@w2ogroup.com

INVESTOR CONTACT:
Chris Brinzey
Westwicke Partners for CRISPR
339-970-2843
chris.brinzey@westwicke.com
Tuesday, February 28th, 2017 Uncategorized Comments Off on $CRSP Appointment of Jon Terrett, Ph.D., Head of Immuno-Oncology Research and Translation

$KITE Positive Topline Results, Axicabtagene Ciloleucel CAR-T in NHL

  • Met Primary Endpoint of Objective Response Rate (p<0.0001)
  • 41 Percent of Patients in Response and 36 Percent in Complete Response at Month 6
  • At a Median Follow-up of 8.7 Months, Median Overall Survival Not Yet Reached
  • Full Data to be Presented at American Association for Cancer Research in April 2017

Kite Pharma, Inc., (Nasdaq:KITE) today announced positive data from the primary analysis of ZUMA-1 for its lead CAR-T candidate, axicabtagene ciloleucel (previously referred to as KTE-C19), in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL). The study met the primary endpoint of objective response rate (ORR), or rates of tumor response (complete response + partial response) recorded after a single infusion of axicabtagene ciloleucel, with 82 percent (p<0.0001).

These results demonstrate the treatment effect of axicabtagene ciloleucel in a patient population with multiple types of aggressive NHL, including diffuse large B-cell lymphoma (DLBCL) enrolled in Cohort 1, as well as primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) enrolled in Cohort 2.

One hundred one patients were treated in ZUMA-1. The following table shows the ORR and rate of complete response (CR) as well as the month 6 ORR and CR:

DLBCL  (n=77) TFL/PMBCL  (n=24) Combined  (n=101)
ORR (%) CR (%) ORR (%) CR (%) ORR (%) CR (%)
ORR 82 49 83 71 82 54
Month 6 36 31 54 50 41 36

Four of the 101 patients in ongoing CR did not have a month 6 tumor assessment prior to the data cut-off and are therefore categorized as non-responders for month 6 in the table above. These patients have an opportunity to be counted as a month 6 CR in a follow-up analysis, which may increase the month 6 response and month 6 CR rate.

At month 6, 41 percent of treated patients achieved a response, including 36 percent in CR. Five of the 101 patients (5 percent) continue to experience highly significant and durable partial responses (PR) with minimal abnormalities in PET scans. One of these PRs converted to a CR at month 9.

With a median follow-up of 8.7 months for this primary analysis, the median overall survival (OS) has not yet been reached. In a similar patient population, the median OS was estimated to be 6.6 months (SCHOLAR-1 study, ASCO 2016).

The most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). As compared to the interim analysis, grade 3 or higher cytokine release syndrome (CRS) decreased from 18 percent to 13 percent and neurologic events decreased from 34 percent to 28 percent. There were no cases of cerebral edema.

As previously reported at the American Society of Hematology Annual Meeting in 2016, there were three deaths not due to disease progression in the study. Two events, one hemophagocytic lymphohistiocytosis and one cardiac arrest in the setting of CRS, were deemed related to axicabtagene ciloleucel. The third case, a pulmonary embolism, was deemed unrelated. Between the interim analysis that included 62 patients, and this primary analysis which now includes all 101 patients, there were no additional deaths due to adverse events.

“These results with axicabtagene ciloleucel are exceptional and suggest that more than a third of patients with refractory aggressive NHL could potentially be cured after a single infusion of axicabtagene ciloleucel,” said Jeff Wiezorek, M.D., Senior Vice President of Clinical Development. “The ZUMA-1 study was built on a foundation of support and commitment from Dr. Steven Rosenberg and the National Cancer Institute and our ZUMA-1 clinical trial investigators who believed in the potential for CAR-T therapy to change the paradigm of cancer treatment.”

Kite intends to seek regulatory approval of axicabtagene ciloleucel in aggressive NHL based upon the combined data from all 101 patients and plans to complete its rolling submission of the Biologics License Application (BLA) by the end of the first quarter of 2017. In addition, Kite plans to submit a marketing authorization application (MAA) for axicabtagene ciloleucel for the treatment of relapsed or refractory DLBCL, PMBCL and TFL with the European Medicines Agency (EMA) in 2017.

“We know as clinicians that patients with aggressive lymphoma who do not respond to their previous treatments have a very poor prognosis. In fact, we know from the SCHOLAR-1 study, these patients have only an eight percent chance of achieving a complete response with current therapies,” said Frederick L. Locke, M.D., ZUMA-1 Co-Lead Investigator, and Director of Research for the Immune Cell Therapy Program at Moffitt Cancer Center in Tampa, Florida. “Several patients we treated at Moffitt Cancer Center experienced a rapid and durable complete response with this first-of-its kind therapy. The ZUMA-1 study results suggest that axicabtagene ciloleucel could become a new standard of care for patients with refractory aggressive lymphoma.”

Sattva S. Neelapu, M.D., Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, served as a co-lead investigator in the ZUMA-1 trial.

Full data from the primary analysis will be presented at the American Association for Cancer Research in April 2017 in Washington, D.C.

ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program®.

Conference Call and Webcast Details
Kite will host a live conference call and webcast today at 9:00 AM Eastern Time (6:00 AM Pacific Time) to discuss the results of this primary analysis. To access the live conference call by telephone, please dial (888) 771-4371 (U.S.) or (847) 585-4405 (International). The conference ID number for the live call is 44040763. The webcast will be made available on the Company’s website at www.kitepharma.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

About axicabtagene ciloleucel
Kite Pharma’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

About Kite
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability of completing a BLA submission with the FDA, completing an MAA with the EMA, obtaining regulatory approval and commercially launching axicabtagene ciloleucel. Various factors may cause differences between Kite’s expectations and actual results as discussed in greater detail in Kite’s filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended September 30, 2016. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

 

Kite Pharma
Christine Cassiano
SVP, Corporate Communications & Investor Relations
ccassiano@kitepharma.com
or
Greg Mann
VP, Investor Relations
gmann@kitepharma.com

Tuesday, February 28th, 2017 Uncategorized Comments Off on $KITE Positive Topline Results, Axicabtagene Ciloleucel CAR-T in NHL

$DVAX FDA Acceptance HEPLISAV-B

BERKELEY, CA–(February 28, 2017) – Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Dynavax’s responses to the Complete Response Letter (CRL) issued by the FDA in November 2016 for the Biologics License Application for HEPLISAV-B, the company’s vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established August 10, 2017 as the Prescription Drug User Fee Act (PDUFA) action date.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and can lead to cirrhosis of the liver, hepatocellular carcinoma and death. In the United States, the Centers for Disease Control and Prevention estimates that 19,000 hepatitis B infections continue to occur annually, with the vast majority occurring in adults. There is no cure for hepatitis B, and disease prevention through more effective vaccines is critical to reducing the spread of the disease.

About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. In Phase 3 trials, HEPLISAV-B showed higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. The most frequently reported local reaction was injection site pain. The most common systemic reactions were fatigue, headache and malaise, all of which were similar to an existing vaccine.

HEPLISAV-B is administered in two doses over one-month. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year.1 Those who do not complete the series may not be adequately protected against hepatitis B.

Dynavax has worldwide commercial rights to HEPLISAV-B.

About Dynavax
Dynavax is a clinical-stage immunology company focused on leveraging the power of the body’s innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax is developing product candidates for use in multiple cancer indications, as a vaccine for the prevention of hepatitis B and as a disease modifying therapy for asthma. Dynavax’s lead product candidates are SD-101, an investigational cancer immunotherapeutic currently in Phase 1/2 studies, and HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information, visit www.dynavax.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding HEPLISAV-B and FDA review. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the FDA will find the response to the CRL to be satisfactory to support approval; whether the FDA will require additional information or studies; whether the FDA will identify additional issues following review of Dynavax’s response to the CRL; whether the FDA will schedule a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) and if so whether it will impact the timing of FDA review, negatively impact the review or whether the VRBPAC will recommend approval; whether additional manufacturing process enhancements will be required or other issues will arise that will negatively impact the review and approval by the FDA; if approvable, whether the issues will negatively impact the potential scope of the label for HEPLISAV-B; and other risks detailed in the “Risk Factors” section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

1 Nelson, J. et al. American Journal of Public Health, “Compliance with Multiple-Dose Vaccine Schedules Among Older Children, Adolescents and Adults: Results from a Vaccine Safety Datalink Study.” 2009. Vol. 99 No. S2.

Contact:
Ryan Spencer
VP, Corporate Strategy & Communications
510.665.4618
rspencer@dynavax.com

Tuesday, February 28th, 2017 Uncategorized Comments Off on $DVAX FDA Acceptance HEPLISAV-B

$ROX Announces National Supply Agreement with $WMT

Castle Brands to Supply Approximately 4,500 Walmart Stores with Goslings Stormy Ginger Beer

NEW YORK, Feb. 28, 2017  — Castle Brands Inc. (NYSE MKT: ROX), a developer and international marketer of premium and super-premium brands, today announced an agreement to supply Goslings Stormy Ginger Beer and Goslings Stormy Diet Ginger Beer to all U.S. Walmart stores. Consumers can expect to find Goslings Stormy Ginger Beer in Walmart stores in March 2017. In addition to its uses as a stand-alone soft drink and as a mixer, Goslings Stormy Ginger Beer and Goslings Black Seal Rum combine to make the trademarked Dark n’ Stormy ® Cocktail.

John Glover, Chief Operating Officer of Castle Brands said, “Supplying Walmart with both the Regular and Diet Goslings Stormy Ginger Beer adds to the brand’s impressive growth and strengthens our position in the U.S. market. We are pleased that Walmart has implemented a full store roll-out.  We look forward to working with Walmart to promote the continued success of Goslings Stormy Ginger Beer.”

Malcolm Gosling, President of Goslings-Castle Partners Inc., a global export venture between Castle Brands and the Goslings said, “The agreement with Walmart, the world’s largest retailer, to supply approximately 4,500 stores with Goslings Stormy Ginger Beer, which we believe is the largest selling U.S. premium ginger beer, is an indication of the strength and growing value of the Goslings brand.”

About Castle Brands

Castle Brands is a developer and international marketer of premium and super-premium brands including: Jefferson’s®, Jefferson’s Presidential Select, Jefferson’s Reserve®, Jefferson’s Ocean Aged at Sea Bourbon, Jefferson’s Wine Finish Collection and Jefferson’s Wood Experiments, Goslings® Rums, Goslings® Stormy Ginger Beer, Knappogue Castle Whiskey®, Clontarf® Irish Whiskey, Pallini® Limoncello, Boru® Vodka, Brady’s® Irish Cream, The Arran Malt® Single Malt Scotch Whisky, The Robert Burns Scotch Whisky and Machrie Moor Scotch Whisky. Additional information concerning the Company is available on the Company’s website, www.castlebrandsinc.com.

Forward Looking Statements

This press release includes statements of our expectations, intentions, plans and beliefs that constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to come within the safe harbor protection provided by those sections. These statements, which involve risks and uncertainties, relate to the discussion of our business strategies and our expectations concerning future operations, margins, sales, new products and brands, potential joint ventures, potential acquisitions, expenses, profitability, liquidity and capital resources and to analyses and other information that are based on forecasts of future results and estimates of amounts not yet determinable. You can identify these and other forward-looking statements by the use of such words as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “thinks,” “estimates,” “seeks,”  “predicts,” “could,” “projects,” “potential” and other similar terms and phrases, including references to assumptions. These forward looking statements are made based on expectations and beliefs concerning future events affecting us and are subject to uncertainties, risks and factors relating to our operations and business environments, all of which are difficult to predict and many of which are beyond our control, that could cause our actual results to differ materially from those matters expressed or implied by these forward looking statements. These risks include our history of losses and expectation of further losses, our ability to expand our operations in both new and existing markets, our ability to develop or acquire new brands, our relationships with distributors, the success of our marketing activities, the effect of competition in our industry and economic and political conditions generally, including the current economic environment and markets. More information about these and other factors are described under the caption “Risk Factors” in Castle Brands’ Annual Report on Form 10-K for the year ended March 31, 2016, as amended, and other reports we file with the Securities and Exchange Commission. When considering these forward looking statements, you should keep in mind the cautionary statements in this press release and the reports we file with the Securities and Exchange Commission. New risks and uncertainties arise from time to time, and we cannot predict those events or how they may affect us. We assume no obligation to update any forward looking statements after the date of this press release as a result of new information, future events or developments, except as required by the federal securities laws.

Castle Brands Inc.
Investor Relations, 646-356-0200
info@castlebrandsinc.com
www.castlebrandsinc.com

Tuesday, February 28th, 2017 Uncategorized Comments Off on $ROX Announces National Supply Agreement with $WMT

$CBMG Awarded $2.29 Million Grant from CIRM for AlloJoin™

SHANGHAI, China and CUPERTINO, Calif., Feb. 27, 2017 — Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, announced today that the governing Board of the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, has awarded the Company $2.29 million to support pre-clinical studies of AlloJoinTM, CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States.

While CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM in Knee Osteoarthritis (KOA), this latest announcement represents CBMG’s initial entrance into the United States for its “off-the-shelf” allogeneic stem cell candidate AlloJoinTM.

The $2.29 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. After the award, CIRM will be a more active partner with its recipients to further increase the likelihood of clinical success and help advance a pre-clinical applicant’s research along a funding pipeline towards clinical trials. CBMG’s KOA pre-clinical program is considered late-stage, and therefore it meets CIRM 2.0’s intent to accelerate support for clinical stage development for identified candidates of stem cell treatments that demonstrate scientific excellence.

“We are deeply appreciative to CIRM for their support and validation of the therapeutic potential of our KOA therapy,” said Tony (Bizuo) Liu, Chief Executive Officer of CBMG. “We thank Dr. C. Thomas Vangsness, Jr., in the Department of Orthopaedic Surgery at the Keck School of Medicine of the University of Southern California and Dr. Qing Liu-Michael at the Broad Center for Regenerative Medicine and Stem Cell Research at USC, who helped significantly with the grant application process. The CIRM grant is the first step in bringing our allogeneic human adipose-derived mesenchymal stem cell treatment for knee osteoarthritis (AlloJoinTM) to the U.S. market.

Our AlloJoinTM program has previously undergone extensive manufacturing development and pre-clinical studies and is undergoing a Phase I clinical trial in China. In order to demonstrate comparability with cell banks previously produced in China for our U.S. IND filing, we are addressing the pre-clinical answers required for the FDA. With the funds provided by CIRM, we will replicate and validate the manufacturing process and control system at the cGMP facility located at Children’s Hospital Los Angeles to support the filing of an IND with the FDA. The outcome of this grant will enable us to have qualified final cell products ready to use in a Phase I clinical trial with Dr. Vangsness as the Principal Investigator and the Keck School of Medicine of USC as a trial site. Dr. Vangsness is familiar with both stem cell biology and KOA, and has led the only randomized double-blind human clinical study to investigate expanded allogeneic mesenchymal stem cells to date. Our endeavor in the U.S. market will further strengthen our commercialization pipeline.”

CBMG recently announced promising interim 3-month safety data from its Phase I clinical trial in China for AlloJoinTM, its off-the-shelf allogeneic stem cell therapy for KOA. The trial is on schedule to be completed by the third quarter of 2017.

About CIRM

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and to act with a sense of urgency commensurate with that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $3 billion in funding and over 280 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of medicine closer to reality.

For more information, please visit www.cirm.ca.gov.

About Knee Osteoarthritis

According to the Foundation for the National Institutes of Health, there are 27 million Americans with Osteoarthritis (OA), and symptomatic Knee Osteoarthritis (KOA) occurs in 13% of persons aged 60 and older. The International Journal of Rheumatic Diseases, 2011 reports that approximately 57 million people in China suffer from KOA. Currently no treatment exists that can effectively preserve knee joint cartilage or slow the progression of KOA. Current common drug-based methods of management, including anti-inflammatory medications (NSAIDs), only relieve symptoms and carry the risk of side effects. Patients with KOA suffer from compromised mobility, leading to sedentary lifestyles; doubling the risk of cardiovascular diseases, diabetes, and obesity; and increasing the risk of all causes of mortality, colon cancer, high blood pressure, osteoporosis, lipid disorders, depression and anxiety. According to the Epidemiology of Rheumatic Disease (Silman AJ, Hochberg MC. Oxford Univ. Press, 1993:257), 53% of patients with KOA will eventually become disabled.

About Cellular Biomedicine Group (CBMG)

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit www.cellbiomedgroup.com.

Forward-looking Statements

This press release contains forward-looking statements—including descriptions of plans, strategies, trends, specific activities, investments and other non-historical facts—as defined by the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently uncertain, and actual results could differ materially from those anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy (including the devaluation of the RMB by China in August 2015), and other risks detailed in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” “continue” or similar terms or their negations. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

 

Contacts:
Sarah Kelly 
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com

Vivian Chen
Managing Director Investor Relations, Citigate Dewe Rogerson
+1 347 481-3711
vivian.chen@citigatedr.com
Monday, February 27th, 2017 Uncategorized Comments Off on $CBMG Awarded $2.29 Million Grant from CIRM for AlloJoin™

$CRVS to Present at Cowen and Company 37th Annual Health Care Conference

BURLINGAME, Calif., Feb. 27, 2017 — Corvus Pharmaceuticals, Inc. (Nasdaq:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, today announced that the company will present at the Cowen and Company 37th Annual Health Care Conference 2017 in Boston, Massachusetts. The presentation is scheduled for Monday, March 6, at 4:00 p.m. Eastern Time.

A webcast of the presentation will be available live and for 7 days following the event. The webcast may be accessed via the conference website and from the investor relations section of the Corvus website.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of small molecule and antibody agents that target the immune system to treat patients with cancer. These agents block or modify crucial immune checkpoints and reprogram immune T-cells. Corvus’ lead product, CPI-444, is a checkpoint inhibitor that is designed to disable a tumor’s ability to subvert attack by the immune system by inhibiting adenosine in the tumor microenvironment. CPI-444 is a small molecule that is taken orally. CPI-444 is currently being evaluated in a multicenter Phase 1/1b clinical trial in patients with various solid tumors. This successive expansion cohort trial is examining the activity of CPI-444 both as a single agent and in combination with Genentech’s Tecentriq® (atezolizumab), an anti-PD-L1 antibody. Corvus is conducting the trial with Genentech, a member of the Roche Group, under a clinical trial collaboration the two companies entered into in October 2015. For more information, visit: www.corvuspharma.com.

 

Corvus Contact:
Jason Coloma
SVP, Chief Business Officer  
Corvus Pharmaceuticals, Inc. 
+1-650-900-4511
jcoloma@corvuspharma.com

Media Contact:
Julie Normart
Pure Communications
+1-415-946-1087
jnormart@purecommunications.com
Monday, February 27th, 2017 Uncategorized Comments Off on $CRVS to Present at Cowen and Company 37th Annual Health Care Conference

$LJPC Top-Line Results, ATHOS-3 Phase 3 of LJPC-501

— Primary efficacy endpoint analysis highly statistically significant (p<0.00001)

— Trend toward longer survival observed

— New Drug Application planned for second half of 2017

— Company to host conference call and webcast at 8:30 a.m. EST on Monday, Feb. 27, 2017

La Jolla Pharmaceutical Company (Nasdaq: LJPC) (La Jolla), today announced positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) in patients with catecholamine resistant hypotension (CRH).

The analysis of the primary efficacy endpoint, defined as the percentage of patients achieving a pre-specified target blood pressure response, was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treated patients (p<0.00001). In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] for LJPC-501-treated patients.

Throughout the study, safety outcomes were followed by an independent Data Safety Monitoring Board (DSMB). The DSMB recommended that the study continue as originally planned. In this critically ill patient population: 92% of placebo-treated patients compared to 87% of LJPC-501-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treated patients discontinued treatment due to an adverse event. In collaboration with the investigators, La Jolla plans to present and publish detailed results from the ATHOS-3 study later this year.

ATHOS-3 was conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), in which the company and FDA agreed on the study design, study endpoints and study analyses.

“These study results support that angiotensin II, a molecule first synthesized by Dr. Irvine Page at the Cleveland Clinic, improves outcomes in distributive shock patients requiring high-dose catecholamines. Given the high mortality from this condition, it is important to offer physicians another potential treatment option,” said Daniel Sessler, M.D., the Michael Cudahy Professor and Chair of the Department of Outcomes Research at Cleveland Clinic.

“We are grateful to the patients, their families and the dedicated medical teams who contributed to this successful study,” said George F. Tidmarsh, M.D., Ph.D., president and chief executive officer of La Jolla. “We also are very appreciative of the FDA’s advice and contributions in the development of LJPC-501 and look forward to meeting with the FDA to discuss our NDA submission planned for the second half of this year.”

Conference Call at 8:30 a.m. EST on Monday, February 27, 2017

La Jolla will host a conference call and webcast at 8:30 a.m. EST (5:30 a.m. PST) on Monday, February 27, 2017. The conference call can be accessed by dialing 877-359-9508 for domestic callers and 224-357-2393 for international callers. Please provide the operator with the passcode 78311826 to join the conference call or click here for the webcast. A slide presentation accompanying today’s press release and the conference call may also be found on La Jolla’s website at www.ljpc.com under the investor relations section. An archive of the conference call and webcast will be available on La Jolla’s website for 30 days following the call.

About the ATHOS-3 Study

The ATHOS-3 study (https://www.ncbi.nlm.nih.gov/pubmed/28215131) was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study of LJPC-501 in patients with catecholamine resistant hypotension. A total of 344 patients were randomized across nine countries, 321 of whom received study treatment and are included in the primary analysis. Patients were randomized 1:1 to receive either LJPC-501 or placebo on a background of standard-of-care vasopressors selected by the investigators. Randomized patients received their assigned treatment via continuous intravenous infusion.

The primary efficacy endpoint was the percentage of patients with a mean arterial pressure (MAP) ≥ 75 mmHg or a 10 mmHg increase from baseline MAP at 3 hours following the initiation of study treatment without an increase in standard-of-care vasopressors. The study was conducted under a Special Protocol Assessment (SPA) agreed to with the U.S. Food and Drug Administration (FDA) in 2015. The SPA stipulates that a study of this size and design could provide sufficient safety and efficacy signals and an adequate evaluation of the risk/benefit to the patients to support FDA review and consideration for marketing approval.

About LJPC-501

LJPC-501 is La Jolla’s proprietary formulation of synthetic human angiotensin II. Angiotensin II, the major bioactive component of the renin-angiotensin system, serves as one of the body’s central regulators of blood pressure. LJPC-501 is being developed for the treatment of patients with catecholamine resistant hypotension (CRH). LJPC-501 is the first synthetic human angiotensin II product candidate to be tested in a Phase 3 study.

About Catecholamine Resistant Hypotension

Catecholamine resistant hypotension (CRH) is a life-threatening syndrome in patients with distributive shock (dangerously low blood pressure with adequate cardiac function) who cannot achieve target mean arterial pressure (MAP) despite adequate fluid resuscitation and treatment with currently available vasopressors (catecholamines and/or vasopressin). There are approximately 500,000 distributive shock cases in the United States per year, an estimated 200,000 of which develop CRH. More than 50% of CRH patients die within 30 days.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The company has several product candidates in development. LJPC-501 is La Jolla’s proprietary formulation of synthetic human angiotensin II for the potential treatment of catecholamine resistant hypotension. LJPC-401 is La Jolla’s proprietary formulation of synthetic human hepcidin for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. LJPC-30S is La Jolla’s next-generation gentamicin derivative program that is focused on the potential treatment of serious bacterial infections as well as rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy. For more information on La Jolla, please visit www.ljpc.com.

Forward Looking Statement Safe Harbor

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or the company’s future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors, that may cause actual results to be materially different from those anticipated by the forward-looking statements. The company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the company’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s web site www.sec.gov. These risks include, but are not limited to, risks relating to: the timing of the NDA submission for LJPC-501 and prospects for approval of the NDA; risks that the full data set from the ATHOS-3 study will not be consistent with the top-line results of the study; risks relating to the scope of product labels (if approved) and potential market sizes, as well as the broader commercial opportunity; the anticipated timing for regulatory actions; the success of future development activities; potential indications for which the company’s product candidates may be developed; and the expected duration over which the company’s cash balances will fund its operations. Subsequent written and oral forward-looking statements attributable to the company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the company’s reports filed with the SEC. The company expressly disclaims any intent to update any forward-looking statements.

 

Company Contacts
La Jolla Pharmaceutical Company
Sandra Vedrick
Associate Director, Investor Relations & Human Resources
858-256-7910
svedrick@ljpc.com
or
Dennis M. Mulroy
Chief Financial Officer
858-433-6839
dmulroy@ljpc.com
or
Media Contact
LifeSci Public Relations
Matt Middleman, M.D.
646-627-8384
matt.middleman@lifescipublicrelations.com

Monday, February 27th, 2017 Uncategorized Comments Off on $LJPC Top-Line Results, ATHOS-3 Phase 3 of LJPC-501

$HTGM Unveils New Direct-Target Sequencing Chemistry

TUCSON, Ariz., Feb. 27, 2017 — HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM)(“HTG”), a provider of instruments, reagents and services for molecular profiling applications announced that its new direct-target sequencing chemistry will be available in the company’s VERI/O laboratory as a service offering beginning in the first quarter of 2017.  The new chemistry is designed for direct sequencing of specified DNA and, in the future, RNA targets with the same high sensitivity and specificity as the company’s current HTG EdgeSeq chemistry applications. The initial panel planned for the VERI/O laboratory will detect common mutations in the EGFR, KRAS and BRAF genes for retrospective research studies especially from small and difficult samples, such as formalin-fixed, paraffin-embedded (FFPE) tissue.

“We are very excited to be able to offer our customers this added service which, together with our prior service offerings, enables us to provide information on key DNA mutations as well as comprehensive gene expression RNA profiling, all from a single section of FFPE tissue,” said TJ Johnson, HTG’s Chief Executive Officer.  “We have completed our patent application filings and plan to leverage this new chemistry into multiple offerings, including DNA applications such as expanded DNA mutation panels, and detecting microsatellite instability and tumor mutational burden.”

“We are completing final preparations for launching the direct-target sequencing technology and an initial DNA mutation panel in our VERI/O laboratory, and plan to have this panel available to service customers for research uses by the end of this quarter,” added Byron Lawson, HTG’s Vice President of Commercial Operations.

About HTG:

Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013, the company commercialized its first instrument platform and a portfolio of RNA assays that leveraged HTG’s original proprietary nuclease protection chemistry. Continuous innovation promptly led to HTG’s first, now‑patented, sequencing-based chemistry and, in 2014, the company launched its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement: 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected benefits of our new direct-target sequencing, or “version 2,” chemistry and VERI/O laboratory service offerings, our ability to timely commercialize our first version 2 chemistry service offering, and our ability to successfully develop and commercialize service or other product offerings based on our version 2 chemistry. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential,” “future” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the risk that we may not realize the expected benefits from our VERI/O laboratory service offerings or our new technologies, such as the version 2 chemistry, risks associated with the utility of our automation systems, proprietary profiling panels and solutions, and our ability to successfully manufacture and supply our products. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including, without limitation, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts:  
Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com
Monday, February 27th, 2017 Uncategorized Comments Off on $HTGM Unveils New Direct-Target Sequencing Chemistry

$TEUM Taps Nick Barter for EMEA Sales VP

New Hire Brings Proven Service Provider Mobile Telecommunications Sales Expertise; Will Join Team at Mobile World Congress

NEW YORK, Feb. 27, 2017  — Pareteum Corporation (NYSE MKT: TEUM) (“Pareteum” or the “Company”), a leading international provider of mobile networking software and services, today continued the expansion of its global sales team announcing the hiring of Nick Barter to the newly created position of Vice President of Sales, EMEA (Europe, the Middle East and Africa). Nick will be based out of the UK and will immediately focus on securing contracts and partnerships with the large numbers of communications service providers operating throughout the EMEA.

Mr. Barter started his career in the Royal Navy and went on to achieve a law degree before entering the world of commerce. Initially joining Videotron as a commercial manager, Nick was then recruited by British Telecom (BT) to head-up the sales and marketing department at BT Cable TV. His career also includes over 15 years in the wholesale telecoms market and working with a number of European and North American MVNO, Internet of Things (IoT) and Machine to Machine operations at companies including Cloud9 Telephony and Limitless Mobile.

“We are pleased to welcome Nick as the latest addition to our growing global sales team. Nick brings with him immediate value due to his extensive global network of relationships including the recently secured business with Sol Mobile and Pronto Telecommunications, as well as direct practical experience in meeting the evolving needs of telecommunications operators and communications service providers,” said Vic Bozzo. “We have seen growing interest in Pareteum’s portfolio of mobile software and services and building momentum behind our Mobility Cloud Platform which continues to add important new capabilities and functionality such as advanced messaging and IoT. We are confident that Nick will be able to immediately contribute new relationships and contracts, assisting our efforts to capitalize on the demand for our services, especially from the vast number of potential customers and partners in the EMEA who need to quickly deploy new communications services,” added Mr. Bozzo, CEO of Pareteum.

Nick Barter commented, “Throughout my career, I have assisted global communication providers address the challenges of emerging technologies and the entry of new competitors by helping them adapt, expand their markets and drive new service revenues. I believe Pareteum’s service offerings and capabilities are uniquely suited to the mobile industry’s transformation to the cloud and the growing need for connectivity supporting increasing numbers of connected wireless devices. Additionally, Pareteum’s innovative technology will help speed deployment of critical emerging applications including advanced messaging and IoT, greatly expanding the opportunities for both entrepreneurial and well-established providers throughout the region who are actively seeking ways to grow their businesses.”

Additionally, the Company noted that it is also attending this year’s Mobile World Congress in Barcelona, Spain, being held from February 27th through March 2rd. Pareteum executives and staff including Vic Bozzo and Nick Barter will be hosting meetings with partners and customers at its booth located at Hall 2, Stand 2O48MR during the event.

About Pareteum Corporation:
Pareteum Corporation and its subsidiaries provide a complete mobility cloud platform, utilizing messaging and security capabilities for the global Mobile, MVNO, Enterprise, SaaS and IoT markets. Mobile Network Operator (MNO) customers include Vodafone, the world’s second largest mobile operator by customer count, Zain, the 4th largest mobile operator in the world in terms of geographical presence and other Tier 1 operators, MVNO customers such as Lebara and Lowi, and partners including Cleartech and Expeto. For more information please visit: www.pareteum.com.

Forward-Looking Statements:
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Pareteum’s plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current expectations, estimates and projections about Pareteum’s industry, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Pareteum may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Pareteum also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Pareteum’s filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Pareteum Corporation.

Shareholder Contact:

Steve Gersten
(813) 926-8920
InvestorRelations@Pareteum.com

Investor Relations Contact:

Jon Cunningham
(407) 712-8969
Jon@RedChip.com

Monday, February 27th, 2017 Uncategorized Comments Off on $TEUM Taps Nick Barter for EMEA Sales VP

$EXPI to Present at Annual ROTH Conference

BELLINGHAM, WA–(February 27, 2017) – eXp World Holdings, Inc. (OTCQB: EXPI), the holding company for eXp Realty LLC, The Agent-Owned Cloud Brokerage®, has been invited to present at the 29th Annual ROTH Capital Partners Conference. The conference is being held on March 12-15, 2017 at the Ritz-Carlton, Laguna Niguel in Dana Point, California.

Management will host one-on-one meetings throughout the day and is scheduled to present as follows:

29th Annual ROTH Conference
Date: Monday, March 13, 2017
Presentation Time: 8:00 a.m. Pacific time
Location: Ritz Carlton, Laguna Niguel, The Promenade – White (1 Ritz Carlton Dr., Dana Point, CA 92629)
Webcast: http://wsw.com/webcast/roth31/expi

Conference participation is by invitation only and registration is mandatory. For more information on the conference or to schedule a one-on-one meeting, please contact your ROTH representative.

About eXp World Holdings, Inc.
eXp World Holdings, Inc. (OTCQB: EXPI) is the holding company for a number of companies, most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.

As a publicly-traded company, eXp World Holdings, Inc. uniquely offers real estate professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.

For more information, please visit the Company’s Twitter, LinkedIn, Facebook, YouTube, or visit www.eXpRealty.com.

Investor Relations Contact:
Greg Falesnik
MZ Group – MZ North America
greg.falesnik@mzgroup.us
www.mzgroup.us
949-385-6449

Corporate Inquiries:
Glenn Sanford
CEO – eXp World Holdings, Inc.
glenn@expworldholdings.com
www.expworldholdings.com
360-685-4206

Monday, February 27th, 2017 Uncategorized Comments Off on $EXPI to Present at Annual ROTH Conference

$JVA Acquires Comfort Foods Inc.

STATEN ISLAND, NY–(Feb 24, 2017) – Coffee Holding Co., Inc. (“Coffee Holding” or the “Company”) (NASDAQ: JVA) announces the acquisition of Comfort Foods Inc., located in North Andover, Massachusetts, a medium sized regional roaster, manufacturing both branded and private label coffee for retail and foodservice customers located predominantly in the northeast marketplace. In connection with the acquisition, the Company paid $2.3 million for 100% of the capital stock of Comfort Foods which had approximately $7.3 million in trailing twelve month revenues.

Comfort Foods was incorporated in August 1992 as a distributor of quality gourmet coffee in distinctive expanded canisters. The use of 100% Arabica beans in patented, trademarked expanded canisters has positioned Comfort Foods’ Harmony Bay brand as a premium coffee at a competitive price point. Multiple coffee profiles are available to customers in their trademarked cans in sizes ranging from 10-48oz throughout the United States in various grocers, mass-merchants and specialty stores. In addition, over the past five years, Harmony Bay has introduced its products in its 4-corner flexible packaging bags. These attractive bags are available in various product profiles in volumes of 28-40oz. Comfort Foods also provides roasting and packaging services for various private labels, co-packing and licensing customers.

“We are excited to bring Comfort Foods and its Harmony Bay brand coffee into our already diverse portfolio of strong regional retail coffee brands. The Harmony Bay brand, with its uniquely patented molded canisters and diverse flavor profiles is currently sold in over 1,000 stores and will increase our overall presence and subsequent economies of scale at many of these current retail accounts in the northeast. In addition, through our national platform, we believe we can expand the brand’s distribution over a wider marketing area,” said Andrew Gordon, President and CEO of Coffee Holding. “In addition, we will once again begin roasting and packaging our products on the east coast in the fully equipped and spacious modern roasting facility we have acquired. In conjunction to closing this transaction, we renegotiated Comfort Foods’ prior lease arrangement which will now provide us with both a highly efficient and economical space in which to conduct our roasting and packaging operations for the next ten years. We believe this transaction will create logistical savings for many of our sales transacted on the eastern seaboard and will also increase our competitive advantage at a number of current and potential accounts in the northeast marketing area. We expect the synergistic value of roasting both in Colorado and Massachusetts to translate to higher margins and renewed efficiencies for both current and potential new business.”

About Coffee Holding

Coffee Holding Co., Inc. is a leading integrated wholesale coffee roaster and dealer in the United States and one of the few coffee companies that offers a broad array of coffee products across the entire spectrum of consumer tastes, preferences and price points. Coffee Holding has been a family-operated business for three generations and has remained profitable through varying cycles in the coffee industry and the economy. The Company’s private label and branded coffee products are sold throughout the United States, Canada and abroad to supermarkets, wholesalers, and individually owned and multi-unit retail customers.

Any statements that are not historical facts contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including the Company’s outlook on future margin performance and its share repurchase program. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. We have based these forward-looking statements upon information available to management as of the date of this release and management’s expectations and projections about certain future events. It is possible that the assumptions made by management for purposes of such statements may not materialize. Such statements may involve risks and uncertainties, including but not limited to those relating to product demand, pricing, market acceptance, hedging activities, the effect of economic conditions, intellectual property rights, the outcome of competitive products, risks in product development, the results of financing efforts, the ability to complete transactions, and other factors discussed from time to time in the Company’s Securities and Exchange Commission filings. The Company undertakes no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made.

Company Contact

Coffee Holding Co., Inc.
Andrew Gordon
President & CEO
718-832-0800

Friday, February 24th, 2017 Uncategorized Comments Off on $JVA Acquires Comfort Foods Inc.

$NDLS to Participate at Two Upcoming Investor Conferences

BROOMFIELD, Colo., Feb. 24, 2017  — Noodles & Company (NASDAQ:NDLS) today announced that it will participate at two investor conferences in March.

  • On Wednesday, March 8, 2017, the Company will meet with investors at the UBS Global Consumer & Retail Conference at the Four Seasons Hotel in Boston.
  • On Wednesday, March 15, 2017, the Company will meet with investors at the Bank of America Merrill Lynch 2017 Consumer & Retail Conference at the Lotte New York Palace in New York.

As previously announced, the Company will host a conference call to discuss its fourth quarter and full year 2016 financial results on Thursday, March 2, 2017 at 8:30 a.m. EST. A press release with fourth quarter and full year 2016 financial results will be issued prior to the call.  The conference call can be accessed live over the phone by dialing (877) 303-1298 or for international callers by dialing (253) 237-1032.  The conference call will also be webcast live from the Company’s corporate website at investor.noodles.com under the “Events & Presentations” page.

About Noodles & Company
Noodles & Company is a fast-casual restaurant chain where its globally inspired dishes come together to create a World Kitchen. Recognized previously by Parents magazine as a Top Family Friendly Restaurant and by Health magazine as one of America’s Healthiest Fast Food Restaurants, Noodles & Company is a restaurant where Japanese Pan Noodles rest comfortably next to Penne Rosa and Wisconsin Mac & Cheese, but where world flavors don’t end at just noodles. Inspired by some of the world’s most celebrated flavor combinations, Noodles & Company’s menu offers soups, salads and shareables. Noodles & Company makes everything fresh to order, just as you like it, using quality ingredients. Servers deliver dishes to the table, allowing guests to sit and relax or grab a quick bite.

Contacts:
Investor Relations
investorrelations@noodles.com 

Media
Danielle Moore 
(720) 214-1971
press@noodles.com
Friday, February 24th, 2017 Uncategorized Comments Off on $NDLS to Participate at Two Upcoming Investor Conferences

$RMGN Converts Supply Chain Pilot with Key Initial Rollout Sales Order

RMG’s innovative visual communications software platform leads to increase in productivity at distribution center resulting in an additional sale in fourth quarter

DALLAS, TX–(Feb 24, 2017) – RMG Networks Holding Corporation (NASDAQ: RMGN), or RMG, a global leader in technology-driven visual communications, recently converted one of its Visual Supply Chain pilots, into a contract, for the first stage of what has the potential of being a major company-wide rollout in 2017 and beyond. The customer, a $10 billion global manufacturing company with 50 facilities world-wide, implemented a pilot of RMG’s Visual Supply Chain solution in mid-2016, to streamline its operations by improving internal communications and productivity at its distribution centers. The success of the distribution center pilot led to a secondary project awarded in December 2016 for more than $250,000, at one of its manufacturing facilities.

The customer tasked RMG to design and install a pilot of RMG’s proprietary Visual Supply Chain solution, featuring an innovative internal communications software platform, at one of the customer’s main distribution centers in an effort to achieve its productivity improvement goals. RMG’s internal communications software platform involves aggregating, synthesizing and displaying real-time key performance indicators on digital signage scoreboards. As a result of using the RMG platform, the customer saw a significant improvement in employee productivity, due to an increase in the flow and timeliness of critical information to employees. Based on the success achieved during this pilot implementation, the customer is beginning to implement the RMG solution across a wider area of the customer’s manufacturing / distribution network, beginning with this additional order, that was awarded in December.

Feedback from the customer included praise for the sharp, crisp and clear screens being an excellent tool to facilitate constant communication and drive productivity. In addition, the distribution center manager reported that overall employee communication has improved and RMG’s supply chain solution will be integral in the facility’s day-to-day business practices moving forward. This success led to a sales order in the fourth quarter for a similar project in the company’s manufacturing facility.

“This supply chain solution is just the beginning of many advances in employee and operational productivity for our customer,” said Robert Michelson, Chief Executive Officer and President of RMG Networks. “We are thrilled to be a part of their success, and this is a perfect example of how RMG is able to affect change and provide world-class innovation that leads to profitability for our customers.”

About RMG

RMG (NASDAQ: RMGN) goes beyond traditional communications to help businesses increase productivity, efficiency and engagement through digital messaging. By combining best-in-class software, hardware, business applications and services, RMG offers a single point of accountability for integrated data visualization and real-time performance management. The company is headquartered in Dallas, Texas, with additional offices in the United States, United Kingdom and the United Arab Emirates. For more information, visit www.rmgnetworks.com.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information contained herein, the matters set forth in this release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “develop,” “position,” “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our success in implementing projects such as the described above, the customer’s plans to implement RMG solutions at other sites, expected future operating results, such as generating product revenue therefrom, developing new technology or solutions, our ability to win new customers and our ability to appeal to new market segments. The forward-looking statements set forth above involve a number of risks and uncertainties that could cause actual results to differ materially from any such statement, including the risks and uncertainties discussed in the company’s Safe Harbor Compliance Statement for Forward-Looking Statements included in the company’s recent filings, including Forms 10-K and 10-Q, with the Securities and Exchange Commission. The forward-looking statements speak only as of the date made, and the company undertakes no obligation to update these forward-looking statements.

Media Contact:

Gloria Lee
972-744-3958
Email Contact

Investor Contact:
Rob Fink/Brett Maas
646-415-8972 / 646-536-7331
Email Contact

Friday, February 24th, 2017 Uncategorized Comments Off on $RMGN Converts Supply Chain Pilot with Key Initial Rollout Sales Order

$VUZI Enters into Development Agreement with Toshiba

Vuzix expects volume production to commence in Q4 of 2017

ROCHESTER, N.Y., Feb. 24, 2017  — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or the “Company”), a leading supplier of Smart Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets, is pleased to announce that the Company has signed an agreement to build a customized pair of smart glasses, for Toshiba Client Solutions Co. Ltd. (Toshiba), a wholly owned subsidiary of Toshiba Corporation. Based in Tokyo, Toshiba Corporation is a world leader and innovator in pioneering high technology, a diversified manufacturer and marketer of advanced electronic and electrical products covering consumer, enterprise, industrial and infrastructure markets. Toshiba Corporation is one of the largest electronics and technology companies in the world.

Under the terms of this agreement, Vuzix and Toshiba have embarked on a rapid development program with milestone payments totaling over one million US dollars. With development efforts well under way, Toshiba, subject to a final manufacturing agreement, expects to place additional purchase orders from Vuzix for production deliveries in the 4th quarter of 2017. Further details on the new smart glasses product will be released soon after public marketing of the product commences.

“We are excited to enter into this partnership with Toshiba and believe it represents a strong vote of confidence in our capabilities and recognition of our leading position within the wearable technology space,” said Paul Travers, President and Chief Executive Officer at Vuzix. “Additionally, the agreement demonstrates how we are leveraging and partnering our industry leading technology with top tier global partners.  We trust that this will be the first of many ongoing collaborations between the firms.”

“We have selected Vuzix as our new smart glasses development and manufacturing partner because we are very impressed with Vuzix’ current line of smart glasses and other technology that the Company has in development. We believe that Toshiba can leapfrog other wearable technology products with Vuzix’ support and look forward to a very successful collaboration between the companies,” said Carl Pinto, vice president of marketing and product development for Toshiba Client Solutions Division, Toshiba America Information Systems, Inc.

About Vuzix Corporation

Vuzix is a leading supplier of Smart-Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets. The Company’s products include personal display and wearable computing devices that offer users a portable high quality viewing experience, provide solutions for mobility, wearable displays and virtual and augmented reality. Vuzix holds 49 patents and 43 additional patents pending and numerous IP licenses in the Video Eyewear field. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2017 and several wireless technology innovation awards among others. Founded in 1997, Vuzix is a public company (NASDAQ: VUZI) with offices in Rochester, NY; Oxford, UK; and Tokyo, Japan.

Forward-Looking Statements Disclaimer

Certain statements contained in this news release are “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward looking statements contained in this release relate to the new development project with Toshiba, its success and the potential of ultimate volume production, and among other things, the Company’s leadership in the Video Eyewear, VR and AR display industry. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and MD&A filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

For further information:

Media and Investor Relations Contact:

Matt Margolis, Director of Corporate Communications and Investor Relations, Vuzix Corporation 
matt_margolis@vuzix.com
Tel: (585) 359-5952

Andrew Haag, Managing Partner, IRTH Communications
vuzi@irthcommunications.com Tel: (866) 976-4784

For further sales, and product information, please visit:

North America:
http://www.vuzix.com/contact/

Europe/UK:
https://www.vuzix.eu/contact/

Asia:
http://www.vuzix.jp/contact.html

Friday, February 24th, 2017 Uncategorized Comments Off on $VUZI Enters into Development Agreement with Toshiba

$IPCI Announces FDA Approval for 500 mg and 750 mg Generic Glucophage® XR

TORONTO, Feb. 24, 2017  — 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 announced that the Company today received final approval from the U.S. Food and Drug Administration (“FDA”) for the Company’s abbreviated new drug application (“ANDA”) for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths.  The Company’s newly approved product is a generic equivalent for the corresponding strengths of the branded product Glucophage® XR sold in the United States by Bristol-Myers Squibb.

Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, “FDA approval of our application for a generic version of Glucophage® XR provides further indication that the FDA is making progress to clear its backlog of ANDA drug candidates under review, and further validation of our core drug development and regulatory capability. We are encouraged that some of the Company’s other 8 ANDA candidates may be accorded further attention soon. We are actively evaluating options to realize commercial returns from this new approval.”

Glucophage® XR, and the drug active metformin, are indicated for use in the management of type 2 diabetes treatment. According to Symphony Health Solutions, sales in the United States for the 12 months ended January 2017 of the 500 mg and 750 mg strengths of Glucophage® XR and all generic equivalents, were approximately $591 million (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price). The Company is aware that other generic versions of this product are currently available in the market. There can be no assurance that the Company’s metformin extended-release tablets for the 500 mg and 750 mg strengths will be successfully commercialized.

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 (some of which have received FDA approval) and product candidates in various stages of development, including ANDAs 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 (“NDA”) 505(b)(2) specialty drug product candidates in its development pipeline. These include RexistaTM (abuse deterrent oxycodone hydrochloride extended release tablets), based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules). Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both RexistaTM and Regabatin™.  The 505(b)(2) pathway (which relies in part upon the approving agency’s findings for a previously approved drug) both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. An advantage of our strategy for development of NDA 505(b)(2) drugs is that our product candidates can, if approved for sale by the FDA, potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route.

Cautionary Statement Regarding Forward-Looking Information

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,” “plans to,” “anticipates,” “believes,” “estimates,” “predicts,” “confident”, “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 ability to maintain compliance with the continued listing requirements of the principal markets on which our securities are traded, 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 difficulty in predicting the timing and results of any product launches, 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, delays that may be caused by changing regulatory requirements, the difficulty in predicting the timing of regulatory approval and launch of competitive products, the difficulty in predicting the impact of competitive products on volume, pricing, rebates and other allowances, the inability to forecast wholesaler demand and/or wholesaler buying patterns, the seasonal fluctuation in the numbers of prescriptions written for our Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules which may produce substantial fluctuations in revenues, the timing and amount of insurance reimbursement for our products, changes in laws and regulations affecting the conditions required by the FDA for approval, testing and labeling of drugs including abuse or overdose deterrent properties, and changes affecting how opioids are regulated and prescribed by physicians, changes in 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, challenges related to the development, commercialization, technology transfer, scale-up, and/or process validation of manufacturing processes for our product candidates, the manufacturing capacity of third-party manufacturers that we may use for our products, 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, difficulties, delays or changes in the FDA approval process or test criteria for ANDAs and NDAs, challenges in securing final FDA approval for our products or product candidates including, RexistaTM in particular, if a patent infringement suit is filed against us, which could delay the FDA’s final approval of such product candidates, the FDA may not approve requested product labeling for our product candidate(s) having abuse-deterrent properties, risks associated with cyber-security and the potential for vulnerability of the digital information of the Company or a current and/or future drug development or commercialization partner of the Company and risks arising from the ability and willingness of our third-party commercialization partners to provide documentation that may be required to support information on revenues earned by us from those commercialization partners. 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.

Trademarks used herein are the property of their respective holders.

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
Friday, February 24th, 2017 Uncategorized Comments Off on $IPCI Announces FDA Approval for 500 mg and 750 mg Generic Glucophage® XR

$CEMP Fusidic Acid Achieves Primary Endpoint in Phase 3 Study of ABSSSI

—Fusidic acid met primary endpoint and secondary efficacy endpoints—

—Fusidic acid well tolerated in the study—

CHAPEL HILL, N.C., Feb. 24, 2017 — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for the acute care and community settings to meet critical medical needs in the treatment of infectious diseases, today announced positive topline results from a phase 3 study of oral fusidic acid in 716 patients with acute bacterial skin and skin structure infections (ABSSSI). Fusidic acid was well tolerated in the study and achieved the primary endpoint, demonstrating non-inferiority (NI) (10% NI margin) of oral fusidic acid compared to oral linezolid for early clinical response (ECR) in the intent to treat (ITT) patient population.

Study Design and Demographics

The double-blind study was conducted at 62 sites in the United States. Patients randomized to treatment with oral fusidic acid received a loading dose of 1500 mg every 12 hours for two doses, followed by 600 mg every 12 hours thereafter, until the end of a 10 day course of therapy. Patients randomized to treatment with the active comparator, oral linezolid, received 600 mg every 12 hours for 10 days. Randomization was 1:1 and was stratified by type of infection (cellulitis, wound infection, major cutaneous abscess), by age and by prior use of an antibiotic within 36 hours prior to randomization.

Overall, 67.5 percent of study subjects had an infection associated with intravenous drug abuse. Less than five percent of study subjects received an antibiotic prior to randomization.

Balanced Baseline Demographic Characteristics

ITT Population Fusidic Acid
N=359
Linezolid
N=357
Sex, n (%)
Male 244 (68.0) 218 (61.1)
Female 115 (32.0) 139 (38.9)
Infection Type, n (%)
Major Cutaneous Abscess 46 (12.8) 47 (13.2)
Cellulitis 92 (25.6) 92 (25.8)
Wound Infection 221 (61.6) 218 (61.1)
Prior Antibiotic Usage, n (%)
Yes 17 (4.7) 18 (5.0)
No 342 (95.3) 339 (95.0)
Recent or Ongoing IV Drug Abuse, n (%)
Yes 245 (68.2) 238 (66.7)
No 114 (31.8) 119 (33.3)

Consistent Efficacy at ECR, End-of-Treatment (EOT) and Post-therapy Evaluation (PTE) 

The primary endpoint, ECR in the ITT population, was defined as the proportion of patients alive and achieving a ≥ 20 percent reduction from baseline in lesion size at 48-72 hours after the start of study drug, without receiving rescue antibiotics. In the study, 87.2 percent of ITT patients receiving fusidic acid demonstrated ECR, compared to 86.6 percent of ITT patients receiving linezolid (treatment difference 0.6%, 95% confidence interval (CI) -4.6, +5.9), demonstrating non-inferiority to linezolid.

Fusidic acid also showed comparable efficacy to linezolid in investigator-assessed clinical response in the ITT and clinically evaluable (CE) populations at EOT and PTE (7-14 days post-EOT) visits.

Clinical Response by Population

Fusidic Acid Linezolid Treatment Difference (95% CI)
ITT Population
ECR (Primary Endpoint) 87.2 % (313/359) 86.6 % (309/357) +0.6  (-4.6, +5.9)
Clinical Success at EOT 91.9 % (330/359) 89.6 % (320/357) +2.3 (-2.2, +6.8)
Clinical Success at PTE 88.6 % (320/359) 88.5 % (316/357) +0.1 (-4.9, +5.0)
CE Populations
Clinical Success at EOT (CE-EOT) 97.1 % (303/312) 97.3 % (288/296) -0.2 (-3.1, +2.8)
Clinical Success at PTE (CE-PTE) 95.7 % (292/305) 96.9 % (283/292) -1.2 (-4.5, +2.2)

Strong Activity Against Key Pathogens, Including MRSA

Microbiological response rates by pathogen were high in both treatment groups in both the microbiological ITT (mITT) and microbiologically-evaluable (ME) patient populations (patients with isolation of a baseline pathogen, who were also clinically evaluable). The most common pathogens identified were Staphylococcus aureus, Streptococcus anginosus group species, Streptococcus pyogenes and Clostridium species. Notably, the microbiological success rate among fusidic acid recipients in each ME population with methicillin-resistant S. aureus (MRSA) infection was 100 percent (99/99) at both the EOT and PTE visits.

Fusidic Acid Well Tolerated

Fusidic acid was well tolerated in the study. The rates of treatment-emergent adverse events (TEAEs) were comparable between treatment groups (37.9 percent fusidic acid, 36.1 percent linezolid). The most common TEAEs in both treatment groups were gastrointestinal events (22.8 percent fusidic acid, 18.2 percent linezolid). Serious adverse events (SAEs) occurred in six fusidic acid recipients and eight linezolid recipients, and were considered study-drug related in one fusidic acid recipient (vomiting) and in two linezolid recipients (one drug induced liver injury, one vomiting). Adverse events led to study drug discontinuation in 2.2 percent of fusidic acid recipients, and 2.0 percent of linezolid recipients. There was one death in the study, an event due to illicit drug overdose and aspiration which occurred in a patient receiving linezolid. Rates of treatment-emergent ALT elevation to >3x ULN occurred in 1.0 percent of fusidic acid recipients and 0.7 percent of linezolid patients.

“Considering complicated skin infections are one of the most rapidly growing reasons for hospitalizations and emergency department visits each year, the results with fusidic acid in this study are promising, especially for an outpatient population where there is a need for new oral drugs that are effective against MRSA,” said William O’Riordan, M.D., chief medical officer of eStudySite, leaders in evaluating new therapeutic approaches for complicated skin infections.

Cempra plans to submit the full data from this study for presentation at an upcoming scientific forum.

“We are excited that the results of this phase 3 study with fusidic acid confirm the results of our phase 2 study and are consistent with the more than 40 years of experience that the product has accumulated outside the United States,” said David Oldach, M.D., chief medical officer of Cempra.

“We look forward to meeting with the FDA to discuss the next steps required to bring fusidic acid to patients in the United States,” Oldach added.

About Fusidic Acid

Cempra is developing fusidic acid exclusively in the U.S. for ABSSSI and is exploring its use for the long term oral treatment of refractory bone and joint infections. Fusidic acid is orally active against gram-positive bacteria, including Staphylococcus aureus strains such as healthcare-acquired methicillin-resistant Staphylococcus aureus (HA-MRSA) and community-acquired MRSA. Cempra completed a phase 2 clinical trial in patients with ABSSSI, which is frequently caused by MRSA, demonstrating a tolerability profile and efficacy comparable to linezolid, one of the few oral antibiotics with FDA approval for the treatment of MRSA. A phase 2 trial in patients with primarily staphylococcal infections of prosthetic hip and knee joints demonstrated that fusidic acid, in combination with rifampin, was generally comparable to intravenous standard of care antibiotics. Cempra has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints.

About Cempra, Inc.

Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for the acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Cempra’s two lead product candidates are currently in advanced clinical development. Solithromycin has been evaluated in two phase 3 clinical trials for community-acquired bacterial pneumonia (CABP). Cempra is currently seeking approval for both intravenous and oral capsule formulations from the U.S. Food and Drug Administration and the European Medicines Agency. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin is also in a phase 3 clinical trial for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Fusidic acid is Cempra’s second product candidate, which has completed an initial phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Cempra also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is also studying solithromycin for ophthalmic conditions and has synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our ability to address the issues identified by the FDA in the complete response letter relating to our new drug applications for solithromycin for community acquired bacterial pneumonia; our ability to obtain FDA and foreign regulatory approval of solithromycin as a treatment for community acquired bacterial pneumonia; the impact of the recently announced changes in senior management and our ability to retain and hire necessary employees and to staff our operations appropriately; our anticipated capital expenditures and our estimates regarding our capital requirements, including the costs of addressing the complete response letter; our dependence on the success of solithromycin and fusidic acid; our and our strategic commercial partners’ ability to obtain FDA and foreign regulatory approval of our product candidates; the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; results of our and our strategic commercial partners’ pre-clinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and fusidic acid; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our ability to produce and sell any approved products and the price we are able to realize for those products; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our ability to compete in our industry; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

Company Contact:
John Bluth
Cempra, Inc.
+1 984 209 4534
jbluth@cempra.com

Investor Contact:
Robert Uhl
Westwicke Partners, LLC
+1 858 356 5932
robert.uhl@westwicke.com

Media Contact: 
Melyssa Weible
Elixir Health PR
+1 201 723 5805
mweible@elixirhealthpr.com
Friday, February 24th, 2017 Uncategorized Comments Off on $CEMP Fusidic Acid Achieves Primary Endpoint in Phase 3 Study of ABSSSI

$KMPH Announces Additional Patent Protection for Prodrug Portfolio

US Patent and Trademark Office decision extends additional patent protection to KP201 and the KP511 compound family

CORALVILLE, Iowa, Feb. 23, 2017 — KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced enhancements to its U.S. and global intellectual property estate governing its portfolio of prodrug product candidates.  The United States Patent and Trademark Office (USPTO) issued two new patents: 1) a “Composition of Matter” patent related to the KP511 family of compounds, and 2) a “Dosage and Formulation” patent protection related to KP201.

“These additional patents continue to strengthen our robust estate of intellectual property that underpins our entire prodrug product portfolio,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Our growing patent protection portfolio extends well into the early to mid-2030’s and exemplifies the potential of our prodrug discovery platform to address unmet medical needs in large, established markets by improving one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety.  We believe this protection period provides ample marketing time following the commercial development of our products, offering the potential of both an immediate and a sustained value proposition.”

KemPharm was recently issued U.S. Patent No. 9,566,343 from the USPTO for its patent application entitled “Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydromorphone, prodrugs, methods of making and use thereof.” The patent, which extends through 2032, provides composition of matter protection and adds to the intellectual property moat around KP511, KemPharm’s prodrug of hydromorphone. The patent has issued claims for the use of a specific hydromorphone prodrug to treat pain, as well as claims for decreased side effects and decreased potential for intra-nasal abuse when compared to an equivalent amount of unconjugated hydromorphone.

The USPTO has also issued U.S. Patent No. 9,549,923, a dosage and formulation patent for a composition of KP201, KemPharm’s prodrug of hydrocodone. This patent also has claims to an abuse-deterrent formulation with lower hydrocodone exposure upon intra-nasal administration as compared to an equivalent dose of hydrocodone bitartrate.

About KemPharm

KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology.  KemPharm utilizes its LAT platform technology to generate improved prodrug versions of U.S. Food and Drug Administration (FDA)-approved drugs in the high need areas of pain, attention deficit hyperactivity disorder (ADHD) and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415, an extended-release prodrug of methylphenidate for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product, KP201.  For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.

Caution Concerning Forward-Looking Statements
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the expected features and characteristics of KP511 and KP201 and the sufficiency of KemPharm’s patent portfolio to maintain exclusivity over and protection for its product candidates.  These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm’s financial resources and whether they will be sufficient to meet KemPharm’s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm’s intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; obligations to third parties regarding the potential commercialization or sale of KP415; and the FDA approval process, including without limitation any timelines for related approval. KemPharm’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:	
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com

Media Contact:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com
Thursday, February 23rd, 2017 Uncategorized Comments Off on $KMPH Announces Additional Patent Protection for Prodrug Portfolio

$SILC Regains Status as Preferred #Encryption Solution Supplier

KFAR SAVA, Israel, Feb. 23, 2017  — Silicom Ltd. (NASDAQ: SILC) today announced that one of its biggest customers has selected the Company’s latest Coleto Creek-based encryption cards for its next-generation appliances. Through this major design win, Silicom has regained its status as this customer’s preferred encryption solution supplier, following a three-year hiatus during which the Company worked continuously with both the customer and Intel to provide a solution that satisfied all of the customer’s requirements.

The customer has already placed initial serial production orders for cards to be used in its first next-generation appliance, and expects volumes to grow with the launch of additional new platforms. According to the customer’s projections, orders for these cards will ramp up gradually during 2017, and the full run-rate, beginning in 2018, will reach approximately $8 million per year. In parallel, the customer has initiated discussions regarding future product lines based on Intel’s encryption roadmap.

“We are pleased and proud to have renewed the flow of encryption card Design Wins from this important customer after a long break, demonstrating the depth of the trust in our customer relationships and the significant long-term potential of each and every large client,” commented Shaike Orbach, Silicom’s President & CEO. “When it became clear that we would not be ready with a solution for the customer’s last-generation appliances, we refocused on the next generation, working closely with Intel while continuing to support and brainstorm with the customer. The successful result is evident in the cutting-edge cards for which we received this important Design Win. Now that we have the right products at the right time, the customer has returned to us as its preferred encryption card supplier and initiated discussions regarding future products.”

Mr. Orbach continued, “This demonstrates again, as so many times in the past, how important our customer relationships are for our long-term success. It also demonstrates the ongoing potential of our ‘traditional’ non-Cloud customers – especially the big ones. Our customer focus and differentiated technology, coupled with a creative development team and privileged access to the Intel roadmap, is a winning combination that generates loyalty over time. While the sales process for any one Design Win can be lengthy, our persistence pays off with growth-driving Design Wins and loyal customers.”

About Silicom

Silicom Ltd. is an industry-leading provider of high-performance networking and data infrastructure solutions. Designed primarily to increase data center efficiency, Silicom’s solutions dramatically improve the performance and availability of networking appliances and other server-based systems.

Silicom’s products are used by a large and growing base of OEM customers, many of whom are market leaders, as performance-boosting solutions for their offerings in the Cyber Security, Network Monitoring and Analytics, Traffic Management, Application Delivery, WAN Optimization, High Frequency Trading and other mission-critical segments within the fast-growing data center, enterprise networking, virtualization, cloud computing and big data markets. Silicom’s product portfolio includes multi-port 1/10/25/40/100 Gigabit Ethernet server adapters, Intelligent Bypass solutions, Encryption accelerators, Ultra Low Latency solutions, Time Stamping and other innovative Smart adapters. These products are available for incorporation directly into our OEM customers’ systems, or provided as part of Silicom’s patented SETAC (Server To Appliance Converter), a unique approach to the provision of high quality standard platforms with modular front connectivity.

For more information, please visit: www.silicom.co.il

Statements in this press release which are not historical data are forward-looking statements which involve known and unknown risks, uncertainties, or other factors not under the company’s control, which may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or other expectations implied by these forward-looking statements. These factors include, but are not limited to, those detailed in the company’s periodic filings with the Securities and Exchange Commission. These forward-looking statements can generally be identified as such because the context of the statement will include words, such as “expects,” “should,” “believes,” “anticipates” or words of similar import. Similarly, statements that describe future plans, objectives or goals are also forward-looking statements. In light of significant risks and uncertainties inherent in forward-looking statements, the inclusion of such statements should not be regarded as a representation by the company that it will achieve such forward-looking statements. The company disclaims any duty to update such statements, whether as a result of new information, future events, or otherwise.

 

 

Company Contact:             Eran Gilad, CFO

Silicom Ltd.        

Tel: +972-9-764-4555      

E-mail: erang@silicom.co.il

Investor relations contact:Ehud Helft

GK Investor Relations

Tel: +1-646-201-9246

E-mail : silicom@gkir.com

Thursday, February 23rd, 2017 Uncategorized Comments Off on $SILC Regains Status as Preferred #Encryption Solution Supplier

$CLBS Biosciences Awarded $12.2 Million Grant from #CIRM, Type 1 #Diabetes

BASKING RIDGE, N.J., Feb. 23, 2017 — Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining a select therapeutic development pipeline with an industry-leading development and manufacturing services provider (PCT), announces today that the California Institute for Regenerative Medicine (CIRM) has awarded a grant to Caladrius, providing up to $12.2 million for the development of CLBS03. CLBS03 is the Company’s investigational cell therapy currently being evaluated as a treatment for recent onset type 1 diabetes (T1D) in a Caladrius-sponsored Phase 2 trial, the Sanford Project: T-Rex Study, in collaboration with Sanford Research, a subsidiary of Sanford Health.

The grant from CIRM, which was recommended for approval by its distinguished and independent panel of scientific reviewers, is a significant endorsement of the potential for Caladrius’ novel approach for treating T1D with cell therapy by restoring immune balance. The award has important implications as it is expected to fund a significant portion of the remaining cost of the Company’s Phase 2 trial currently underway. The grant will be used to cover expenses including all manufacturing and development based in California and other trial costs dependent upon the proportion of subjects enrolled in California, with consumption of at least $6 million of the award expected.

CLBS03 uses the patient’s own regulatory T cells (Tregs) to treat autoimmune disease. Tregs are a natural part of the human immune system that regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, it is thought that deficient Treg activity permits the T effector cells to attack the body’s own beneficial cells and, in the case of T1D, insulin-producing pancreatic beta cells, thereby reducing and eventually eliminating the body’s ability to produce sufficient amounts of insulin.

Caladrius’ novel approach seeks to restore immune balance by augmenting the number and activity of a patient’s own Tregs and using their innate capabilities to modulate multiple facets of the effector arm of the immune system.

CLBS03 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA), and Advanced Therapeutic Medicinal Product classification from the European Medicines Agency. Patients are currently being enrolled in the second cohort of the Phase 2 trial, with an interim analysis of early therapeutic effect expected by the end of 2017.

“We are grateful to CIRM and the experts who reviewed and endorsed our application. We firmly believe that this therapy has the potential to improve the lives of people with T1D and this grant helps us advance our Phase 2 clinical study with the goal of determining the potential for CLBS03 to be an effective therapy in this important indication,” said David J. Mazzo, PhD, Caladrius’ Chief Executive Officer. “This grant substantiates our approach to identify and secure non-dilutive funding for our development programs and helps position Caladrius as a leader among cell therapy and autoimmune disease therapy developers.”

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The company’s subsidiary, PCT, is a leading development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. PCT provides a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. For more information on Caladrius please visit www.caladrius.com and for more information on PCT please visit www.pctcaladrius.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.

Contacts:
Investors:
LHA
Anne Marie Fields
Senior Vice President
Phone: +1-212-838-3777
Email: afields@lhai.com                   

Media:
Caladrius Biosciences, Inc.
Eric Powers
Director, Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@caladrius.com
Thursday, February 23rd, 2017 Uncategorized Comments Off on $CLBS Biosciences Awarded $12.2 Million Grant from #CIRM, Type 1 #Diabetes

$RETA Initiation of Phase 2/3 Study of Bardoxolone Methyl in Kidney Disease

IRVING, Texas, Feb. 23, 2017 — Reata Pharmaceuticals, Inc. (NASDAQ:RETA) (“Reata” or the “Company”) today announced the initiation of patient screening in a Phase 2/3 trial to evaluate bardoxolone methyl (“bard”) in patients with chronic kidney disease (“CKD”) caused by Alport syndrome.  The purpose of this study is to determine the safety and efficacy of bard in Alport syndrome patients, and to determine if Alport syndrome patients experience improvements in kidney function similar to those observed in multiple, previous trials of bard in patients with other forms of CKD.  Reata expects data from the Phase 2 portion of the trial to be available, and to decide on entering the Phase 3 portion, by year-end 2017.

The Alport Syndrome Foundation’s Executive Director Gina Parziale said, “As there are currently no FDA approved treatments for those with Alport Syndrome, the Alport Syndrome Foundation encourages the development of therapies that will delay or prevent the need for dialysis and transplantation.  We are grateful to Reata for engaging us in this process and for recognizing the crucial role of the patient perspective.”

“Based on our extensive clinical experience with bardoxolone methyl in patients with diabetic CKD, as well as in our ongoing Phase 2 and Phase 3 trials for bardoxolone in other orphan diseases, we hope to demonstrate that bardoxolone methyl can serve as a meaningful new treatment option for patients with Alport syndrome,” said Warren Huff, Reata’s Chief Executive Officer and President.

Overview of Clinical Trial Program in Alport Syndrome

The Phase 2 portion of the study is open-label and will enroll up to 30 patients from 12 to 60 years old with estimated glomerular filtration rates (eGFR) between 30 to 90 mL/min/1.73 m2.  Fifteen patients with microalbuminuria will receive up to 20 mg of bard once daily, and 15 patients with macroalbuminuria will receive up to 30 mg of bard once daily.  The primary endpoint for the Phase 2 portion of the study is change in eGFR at week 12 compared to baseline.

The Phase 3 portion is designed to support regulatory approval of bard.  This portion will be double-blind and placebo-controlled and will randomize approximately 180 patients on a 1:1 basis to once-daily, oral bard or placebo.  Similar to the Phase 2 portion of the trial, the study will assess dose escalation of bard from 5 mg to a maximum daily dose of 20 mg or 30 mg based on baseline proteinuria at randomization.  The primary efficacy endpoint is the on-treatment change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo after 48 weeks.  The key secondary endpoints will be the change from baseline in eGFR following a 4-week withdrawal of drug after one and two years of treatment.  Based on FDA guidance, if the trial is positive, the year one off-treatment data could support accelerated approval under subpart H of the Food, Drug, and Cosmetic Act, and the year two off-treatment data could support full approval.

About Alport Syndrome

Alport syndrome is a rare, genetic disease caused by mutations in the genes encoding type IV collagen, a major structural component of the glomerular basement membrane (“GBM”) in the kidney.  The abnormal expression of type IV collagen causes loss of GBM integrity, abnormal leakage of proteins such as albumin through the GBM, and excessive reabsorption of protein in the proximal tubules of the kidney.  Like other forms of CKD, excessive reabsorption of protein in the tubules induces oxidative stress, chronic inflammation, and renal interstitial inflammation and fibrosis.

Alport syndrome affects approximately 12,000 people in the United States and 40,000 globally.  Almost all patients with Alport syndrome develop end-stage renal disease (“ESRD”), and approximately 50% of male patients require dialysis or kidney transplant by the age of 25.  There are currently no approved therapies to treat Alport syndrome.

About Bardoxolone Methyl

Bardoxolone methyl is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.  Bardoxolone methyl is currently being studied in CATALYST, a Phase 3 study for the treatment of connective tissue disease associated pulmonary arterial hypertension (CTD-PAH).

About Reata Pharmaceuticals, Inc.

Reata Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation.  Reata’s two most advanced clinical candidates (bardoxolone methyl and omaveloxolone) target an important transcription factor, called Nrf2, to restore mitochondrial function, reduce oxidative stress, and resolve inflammation.

Forward-Looking Statements

This press release includes certain disclosures which contain “forward-looking statements,” including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, our ability to obtain and retain regulatory approval of our product candidates, estimates of our expenses and our needs for additional financing, and our ability to obtain additional financing for our product development activities and existing and future clinical trials and pre-clinical programs.  You can identify forward-looking statements because they contain words such as “believes,” “will,” “may,” “aims,” “plans” and “expects.”  Forward-looking statements are based on Reata’s current expectations and assumptions.  Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance.  Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Reata’s filings with the U.S. Securities and Exchange Commission, including its Registration Statement on Form S-1, as amended from time to time, under the caption “Risk Factors.”  The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

1 Rheault M, Gross O, Appel G, et al. Change in glomerular filtration rate and renal biomarkers in patients with chronic kidney disease due to Alport syndrome: interim results from the ATHENA study, a prospectively designed natural history study.  Nephrol Dial Transplant 2016;31:i126.

2 Jais J, Knebelmann B, Giatras I, et al. X-linked Alport syndrome: natural history in 195 families and genotype- phenotype correlations in males.  J Am Soc Nephrol 2000;11:649-57.

3 Zoja C, Corna D, Locatelli M, et al. Targeting Keap1-Nrf2 Pathway Ameliorates Renal Inflammation and Fibrosis in Mice with Protein-Overload Proteinuria.  Poster American Society of Nephrology Meeting, 2010.

4 Aminzadeh MA, Reisman SA, Vaziri ND, et al. The synthetic triterpenoid RTA dh404 (CDDO-dhTFEA) restores endothelial function impaired by reduced Nrf2 activity in chronic kidney disease.  Redox Biol 2013;1:527-31.

5 Camer D, Yu Y, Szabo A, et al. Bardoxolone methyl prevents the development and progression of cardiac and renal pathophysiologies in mice fed a high-fed diet.  Chem Biol Interact 2016;243:10-18.

 

Contact:
Reata Pharmaceuticals, Inc.
(972) 865-2219
info@reatapharma.com
http://news.reatapharma.com

Investor Relations:
The Trout Group
Lee M. Stern, CFA
(646) 378-2922
IR@reatapharma.com
Thursday, February 23rd, 2017 Uncategorized Comments Off on $RETA Initiation of Phase 2/3 Study of Bardoxolone Methyl in Kidney Disease

$MBVX #FDA Clears #MVT1075 for Phase1 Clinicals in Pancreatic #Cancer

MVT-1075 Combines the Company’s HuMab-5B1 Antibody with the Radiopharmaceutical (177)Lutetium to Treat Pancreatic Cancer. Patient Enrollment in Trial Expected to Begin in First Half of 2017

SAN DIEGO, Feb. 23, 2017  — MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, announces that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with MVT-1075 as a therapeutic treatment for pancreatic cancer. MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1) is the Company’s novel fully human antibody radioimmunotherapy (RIT). MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies the first half in 2017.  This is the third IND authorized by FDA in the last fourteen months by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company’s proprietary cancer vaccines.

The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.

In this initial phase I trial the Company plans to evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075.  Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies.  Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria.  The investigative sites will include Memorial Sloan Kettering Cancer Center in New York City.

In November 2016, MabVax reported positive interim results from two phase I trials.  The first trial is evaluating the Company’s therapeutic antibody MVT-5873, in which safety was reported to have been established at three incremental dose levels by treating patients at three clinical sites.   Patients continue to be recruited to establish the recommended phase II dose (RP2D).  The second trial is evaluating the Company’s Immuno-PET diagnostic agent MVT-2163.  The Company reported that phase I trial results demonstrated acceptable interim safety, pharmacokinetics, and biodistribution. Target specificity was demonstrated by correlation with lesions identified by conventional computerized tomography (CT) scans and patients are actively being recruited to this trial.

David Hansen, MabVax’s President and Chief Executive Officer, said, “We are executing on the development strategy we have outlined and we are excited to take this next step forward.  We are expanding the HuMab-5B1 program to include delivery of a potent new radiotherapy agent.  We are hopeful that this approach will provide a new treatment option for these difficult-to-treat cancers.”

About MabVax:

MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax also has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. Additional information is available at www.mabvax.com.

Forward Looking Statements:

This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to the Company’s clinical trials of MVT-1075, MVT-5873, and MVT-2163. We have no assurance that any of the three product candidates will be fully developed by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2015, as amended and supplemented from time to time and the Company’s Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.

Investor Contact:

MabVax Investor Relations
1-858-500-8456

Thursday, February 23rd, 2017 Uncategorized Comments Off on $MBVX #FDA Clears #MVT1075 for Phase1 Clinicals in Pancreatic #Cancer

$NVFY Record Paying Sign-Ups on Blockchain-Based Site Nova-Mart

LOS ANGELES, Feb. 23, 2017  — Nova LifeStyle, Inc. (NASDAQ:NVFY) or (the “Company”), a U.S. based fast-growing, innovative provider of modern lifestyle products and services today announced that during the month of February, over 1,000 customers and student members have paid for and completed training on the Company’s site, “Nova- Mart,” (www.nova-mart.com) an online transactional platform for consumers and merchants to offer products and business services worldwide based on Blockchain technology.

The Company anticipates paid business services and training to be a significant source of revenue and net income for Nova in the future. As previously announced, Nova is in discussion to acquire a two-million-member customer database from a highly profitable e-commerce website, which could also help the Company gain additional paid sign-ups.

Tawny Lam, President and Interim CEO of Nova LifeStyle commented, “We have seen a tremendous response rate on our recently-formed Blockchain technology-based site Nova-Mart, as customers and student members continue to sign up for training. We anticipate this trend to continue if we can successfully complete the purchase of the database from weilai178.com as planned.”

NVFY’s Future Tech Business School in Hong Kong is now fully operational and offers professional network training courses of Crypto-Assets Blockchain Adoption Application to a growing list of existing and new paying customers and student members. The Company has a goal of registering more than 5,000 members per month for its business training platform in the future.

About Nova LifeStyle
Nova LifeStyle, Inc., a NASDAQ Global Market listed company headquartered in California, is a fast growing, innovative designer, manufacturer and distributor of modern LifeStyle furniture; primarily sofas, dining rooms, cabinets, office furniture and related components, bedrooms, and various accessories in matching collections. Nova LifeStyle also owns and operates Nova-Mart, www.nova-mart.com, a Blockchain technology based e-commerce platform that offers a large variety of products and services to millions of customers worldwide. Visit Nova’s website: www.NovaLifeStyle.com.

Safe Harbor Statement
All statements in this press release that are not historical are forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ from the company’s expectations. You are cautioned not to place undue reliance on any forward-looking statements in this press release as they reflect Nova’s current expectations with respect to future events and are subject to risks and uncertainties that may cause actual results to differ materially from those contemplated. Potential risks and uncertainties include, but are not limited to, the risks described in Nova’s filings with the Securities and Exchange Commission.

Company Contact:
Investor Relations:
The Equity Group Inc.
In U.S.
Adam Prior, Senior Vice President
+1 (212) 836-9606
aprior@equityny.com

In China
Katherine Yao, Senior Associate
+86-10-6587-6435
kyao@equityny.com
Thursday, February 23rd, 2017 Uncategorized Comments Off on $NVFY Record Paying Sign-Ups on Blockchain-Based Site Nova-Mart

$CUR Announces Issuance of U.S. Patent Covering NSI-189

GERMANTOWN, Md., Feb. 22, 2017 — Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of central nervous system therapies based on its neural stem cell technology, today announced that U.S. Patent No. 9572807 was issued by the United States Patent and Trademark Office (USPTO) for NSI-189, the lead compound in Neuralstem’s neurogenic small molecule program in development for the treatment of major depressive disorder. US 9,572,807 has claims to protocols for using NSI-189 and related compounds for treatment of major depressive disorder.  Counterparts have been filed in Australia, Canada, Europe, Japan, Singapore and South Korea.  These patents will expire in June 2035.

The new patent adds to the portfolio of over 20 U.S. and 120 foreign issued and pending patents that are owned or licensed to Neuralstem in the field of regenerative medicine.  This includes U.S. Patent No. 9,540,611, issued on January 10, 2017 by the USPTO, covering the treatment of neurodegenerative diseases using NSI-566, the company’s proprietary neural stem cell therapy candidate.

“We are excited to be bringing forward therapeutic options that could make a tremendous difference in the lives of those who suffer from nervous system disorders and conditions,” said Rich Daly, Chairman and CEO, Neuralstem.  “We will continue to aggressively establish a broad portfolio of intellectual property to protect our research and development efforts.”

About Neuralstem

Neuralstem’s patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.

Neuralstem’s technology enables the generation of small molecule compounds by screening hippocampal stem cell lines with its proprietary systematic chemical screening process.  The screening process has led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brain’s capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.

The company has completed Phase 1a and 1b trials evaluating NSI-189, a novel neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a Phase 2 efficacy study for MDD.

Neuralstem’s stem cell therapy product candidate, NSI-566, is a spinal cord-derived neural stem cell line. Neuralstem is currently evaluating NSI-566 in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

Neuralstem is conducting a Phase 1 safety study for the treatment of paralysis from chronic motor stroke at the BaYi Brain Hospital in Beijing, China.  In addition, NSI-566 is being evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS.  Patients from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits.

Cautionary Statement Regarding Forward Looking Information

This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2015, and Form 10-Q for the nine months ended September 30, 2016, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

Danielle Spangler
Investor Relations
Neuralstem, Inc
301.366.1481

Lori Rosen
Public Relations
LDR Communications
917.553.6808
Wednesday, February 22nd, 2017 Uncategorized Comments Off on $CUR Announces Issuance of U.S. Patent Covering NSI-189

$DELT Continues to Expand Revenues from Core Client Base

ZHENJIANG, China, Feb. 22, 2017  — Delta Technology Holdings Limited (NASDAQ: DELT), a manufacturer and seller of specialty chemicals, today announced that it is increasing both the number of core clients it serves and the amount of product sold to these companies.

“We are confident that the products we produce for pharmaceutical and pesticide companies, and companies in other sectors including clean energy, food additives, aerospace and agrochemical, allow these major firms to achieve successes.  We are very proud of the strategic cooperation these major companies have with Delta Technology,” said Chao Xin, Chairman and CEO.

Delta Technology services giant international chemical companies including Bayer, BASF Corporation, FMC Corporation as well as several public companies in China listed on the Shenzhen Stock Exchange for example:  Jiangsu Flag Chemical Industry Co., Ltd.; Jiangsu Huifeng Agrochemical Co., Ltd., Huapont Life Sciences Co, Ltd. and Jiangsu Changqing Agrochemical Co., Ltd.

About Delta Technology Holdings Ltd.

Founded in 2007, Delta Technology Holdings Ltd. is a leading China-based fine and specialty chemical company producing and distributing organic compound including para-chlorotoluene (“PCT”), ortho-chlorotoluene (“OCT”), PCT/OCT downstream products, unsaturated polyester resin (“UPR”), maleic acid (“MA”) and other by-product chemicals. The end application markets of the Company’s products include Automotive, Pharmaceutical, Agrochemical, Dye & Pigments, Aerospace, Ceramics, Coating-Printing, Clean Energy and Food Additives. Delta has approximately 300 employees, 25% of whom are highly-qualified experts and technical personnel. The Company serves more than 380 clients in various industries.

Safe Harbor Statement

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded or followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,” and similar expressions or future or conditional verbs such as “will”, “should”, “would”, “may” and “could” are generally forward-looking in nature and not historical facts. Forward-looking statements in this release also include statements about business and economic trends. Investors should also consider the areas of risk described under the heading “Forward Looking Statements” and those factors captioned as “Risk Factors” in DELT’s periodic reports under the Securities Exchange Act of 1934, as amended, or in connection with any forward-looking statements that may be made by DELT.

Contact: 

E & E Communications
Paul Knopick
pknopick@eandecommunications.com
940.262.3584 (Texas, USA)

Wednesday, February 22nd, 2017 Uncategorized Comments Off on $DELT Continues to Expand Revenues from Core Client Base