Archive for June, 2015
Tests on Two Car Models Show Spinel(TM) Eliminating Over 90% of PGMs on Underfloor Catalysts
OXNARD, Calif., June 2, 2015 — Clean Diesel Technologies, Inc. (Nasdaq:CDTI) (“CDTi” or “the Company”), a leader in advanced emission control technology, announced initial vehicle test results for Spinel™, its proprietary clean emissions exhaust technology that is expected to dramatically reduce the cost for auto manufacturers to attain increasingly stringent clean air standards.
Initial vehicle tests were conducted at an independent test facility using the industry standard Federal Test Procedure (FTP) on a model year 2014 Buick Regal 2.0 liter turbo-charged gasoline direct injection (GDI) engine. The data demonstrated that a Spinel underfloor catalyst with 97% less platinum group metal (PGM) achieved emissions control performance equivalent to the OEM catalyst. The Spinel catalyst PGM loading was 2g/ft3 compared to 59g/ft3 for the OEM catalyst. The Spinel catalyst at 2g/ft3 also provided equivalent performance to the OEM catalyst at 22g/ft3 on a 2014 Toyota Camry with a 2.5 liter naturally-aspirated engine – a PGM savings of 91%. For many passenger cars, these levels of PGM reduction could translate into double-digit dollar cost savings per vehicle, reinforcing Spinel’s strong value proposition for OEMs.
“These encouraging initial results from rigorous FTP testing demonstrate the significant potential of our Spinel technology,” stated Chris Harris, CDTi’s President and CEO. “Spinel could provide OEMs with a cost-effective solution as they face the prospect of increased PGM usage while phasing in next-generation fuel-efficient engines that must meet tighter emission regulations. Passenger cars typically have two catalysts for different exhaust zones, and our program was designed to develop and test proprietary Spinel systems for the underfloor position first and then move on to testing the close-coupled catalyst. These initial results suggest we now have an ultra-low PGM option for underfloor catalysts. In addition, analysis of the post-test catalysts have provided insights into further improvements, reinforcing the possibility that Spinel eventually might be able to eliminate PGMs altogether. We continue with validation testing on close-coupled catalysts, and we expect to report those results later this year.
“We are excited about recent results for Spinel and our other next-generation technologies – BMARS™ and SPGM™ DOC. These technologies could enable the light and heavy duty vehicle industries to reduce the billions of dollars currently spent on PGMs, as well as address the increasing risks of supply constraints and price volatility surrounding strategic materials like PGMs and rare earths,” Harris concluded.
Benchmark Testing Results
The chart below summarizes the results of the initial vehicle testing conducted on the 2014 Buick Regal at an independent test facility using the industry standard FTP. Results show the oxides of nitrogen (NOx) emission of the OEM system, consisting of a close-coupled catalyst and an underfloor catalyst, compared to the OEM close-coupled catalyst with CDTi’s Spinel underfloor catalyst. The PGM cost reflects that of the underfloor catalyst only, with the PGM price calculated as of May 1, 2015.
A chart accompanying this release is available at http://media.globenewswire.com/cache/9503/file/34558.jpg
About Spinel
The Spinel™ platform is a family of proprietary materials using various base metals that replace costly platinum group metals (PGMs) and rare earth metals in coatings on standard catalytic converters. Spinel is expected to work across a wide range of engine and vehicle applications – both gasoline and diesel – and has the potential for significant cost savings for OEMs by dramatically reducing or eliminating expensive PGMs and rare earth metals. The technology could enable early, cost-effective compliance with stricter emissions standards in the U.S. and around the world, while mitigating OEM exposure to supply uncertainty and price volatility in the PGM and rare earth markets. More information may be obtained at www.cdti.com/spinel.
About CDTi
CDTi manufactures and distributes vehicle emissions control products that leverage its advanced materials technology. CDTi utilizes its proprietary patented Mixed Phase Catalyst (MPC®) technology and other related technologies to provide high-value sustainable solutions to reduce emissions, increase energy efficiency and lower the carbon intensity of on- and off-road combustion engine systems. Reflecting its continued focus on innovation, CDTi is developing and commercializing proprietary advanced low-platinum group metal (PGM) catalysts including synergized-PGM (SPGM™), as well as zero-PGM (ZPGM™) catalysts. CDTi is headquartered in Oxnard, California and has operations in the U.K., Canada, France, Japan and Sweden. For more information, please visit www.cdti.com.
Forward-Looking Statements
Certain information contained in this press release constitutes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including any statements that are not statements of historical fact. You can identify these forward-looking statements by the use of the words “believes”, “expects”, “anticipates”, “plans”, “may”, “will”, “would”, “intends”, “estimates”, “promises”, and other similar expressions, whether in the negative or affirmative. Forward-looking statements are based on a series of expectations, assumptions, estimates and projections which involve substantial uncertainty and risk. In this press release, the Company includes forward looking statements regarding the potential benefits of CDTi’s Spinel technology based on recent test results, and the anticipated further testing, development, potential applications, commercialization opportunities and potential benefits of CDTi’s catalyst technologies including Spinel. In general, actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including, but not limited, to (i) Spinel technology may not achieve results with close-coupled catalysts similar to the results for underfloor catalysts; and, moreover, products or technologies such as Spinel may not achieve the same results in commercial environments as they do in test settings; (ii) that the Company may not be able to (a) decrease costs, (b) increase sales, (c) obtain adequate funding, (d) retain existing or secure new customers (e) protect its intellectual property, (f) successfully evolve into an advanced materials supplier or, even if successful, achieve profitability, (g) successfully market new products; (h) obtain required product verification or approvals, (i) attract or retain key personnel, or (j) realize benefits from investments; (iii) prices of PGM and rare earth metals; (iv) supply disruptions or failures; (v) regulatory, marketing and competitive factors; (vi) environmental harm or damages, (vii) changes in domestic and international market and political conditions; and (viii) other risks and uncertainties discussed or referenced in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. In addition, any forward-looking statements represent the Company’s estimates only as of the date of such statements and should not be relied upon as representing the Company’s estimates as of any subsequent date. The Company specifically disclaims any obligation to update forward-looking statements. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
CONTACT: Becky Herrick or Cathy Mattison
LHA (IR Agency)
+1 415 433 3777
bherrick@lhai.com
cmattison@lhai.com
InVivo Therapeutics Holdings Corp. (NVIV) today announced that the company’s investigational Neuro-Spinal Scaffold has received the 2015 Becker’s Healthcare Spine Device Award. It is one of 25 devices that received this distinction from Becker’s Healthcare. According to their article, “Both ‘tried-and-true’ devices as well as new promising innovations are featured in this year’s awards.” Award nominees are determined by the publication’s editorial staff, in this case Becker’s Spine Review, and are vetted by a panel of industry experts.
Mark Perrin, InVivo Chief Executive Officer and Chairman, said, “We are very pleased to be receiving this notable award, especially from a publication as well respected as Becker’s Spine Review. I’d like to extend my gratitude to Becker’s for the recognition and to all of the members of the InVivo team for making this possible.”
For the full story, please visit the Becker’s Healthcare site, here: http://www.beckersspine.com/lists/item/25625-25-spine-device-awards-2015.html
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com
HelloBeautiful (Women), TheUrbanDaily (Men), NewsOne (Affluent), and GlobalGrind (Millennials) Being Re-imagined
NEW YORK, June 1, 2015 — Interactive One (iOne), the fastest growing and definitive digital platform for the New America, announced today that its flagship destinations will be re-imagined with new designs and features that inject new energy into the popular network of sites. Along with a new look and feel, each site will be rolling out more new content than ever, while offering advertisers additional opportunities to reach a diverse audience that spends twice as long on iOne than its competitors.
The family of brands under the iOne umbrella garner nearly 30 million unique visitors per month (more than double from the same time last year), and reaches 12 million followers on social media. Today, HelloBeautiful.com, the definitive lifestyle destination for Black women is the first of the brands to unveil its new and improved platform, leading in the site flip. In coming months, re-launches will follow for TheUrbanDaily – where men go to get smart, timely and real urban pop-culture and entertainment news; GlobalGrind – an all-encompassing destination for Millennials of all races and backgrounds, that covers the “Hip” side of Pop culture across entertainment, celebrity, music, style & fashion and entrepreneurship; and NewsOne – which will continue to feature up to the minute, comprehensive coverage of newsworthy events relevant to Black Americans across the country and the world.
To enhance the experience for each user, this redesign will debut a variety of curated pages and branded logos that will be tailored to each iOne platform. Following each new website design all of the iOne properties will continue to deliver the content readers have come to value. New features on the new HelloBeautiful site include easy-to-use navigation so readers can quickly find the content they love; high-speed page load, larger high-res graphics; a sleeker color palette; and brand new exclusive content. This includes more video content than ever before, through the recently-launched HB Studios, dedicated to curating compelling original video series and documentaries for women of color. From the home page, to articles, photo galleries & video—the evolved user experience of the new HelloBeautiful.com provides the editors with the ability to promote and prioritize exactly the stories most important to the audience.
“The pulse of America lies with our audience,” said Interactive One President Tom Newman. “By refreshing and upgrading our flagship properties, we are adding new elements and content while maintaining the voice that this growing audience has come to love and appreciate.”
Additionally, with these re-launches will come new ways for advertisers to engage a diverse collection of Black, Latino and/or Millennial audiences. These offerings include:
- Expanded Native Advertising and Sponsored Content Opportunities – building off of the industry leading track record of successfully partnering with brands to create and distribute content;
- New Premium Ad Units – the launch of our new immersive iMpact ad unit: a full page rich media experience with numerous capabilities.
“Our content and advertising teams are working closely to ensure an optimal experience both for consumers visiting our suite of re-designed sites, and advertisers looking to engage with them,” said Interactive One SVP and Head of Sales Maria Weaver. “Cleaner, updated sites featuring more rich media and a look and feel that is less disruptive to advertisers, will result in higher viewability and the opportunity to authentically integrate brands into the consumer experience in a high-impact manner.”
About Interactive One
Interactive One is the fastest growing and definitive digital platform for the New America, reaching millions each month through its suite of online, mobile, social and content offerings. It owns and operates a number of branded destinations, including GlobalGrind (Millennials), HelloBeautiful (Women), NewsOne (Affluent), TheUrbanDaily (Men) and VidaToday (Latino), as well as social networking sites such as BlackPlanet, BlackPlanet RADIO and MiGente, and digital destinations for dozens of local radio stations. Interactive One was launched in 2008 by Radio One, Inc. [NASDAQ: ROIA and ROIAK, radio-one.com] to complement its existing portfolio of media companies targeting Black Americans. Since then, its news, entertainment, video and lifestyle content has driven its growth, with Interactive One reaching 29.4 million unique monthly visitors as of January 2015 (up 138 percent from the prior year). For more information, visit www.interactiveone.com.
SOURCE Interactive One
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Interactive One Re-Launching Flagship Sites with New Content and Advertising Offerings Targeting Diverse Black, Latino and Millennial Audiences
HelloBeautiful (Women), TheUrbanDaily (Men), NewsOne (Affluent), and GlobalGrind (Millennials) Being Re-imagined
NEW YORK, June 1, 2015 /PRNewswire/ — Interactive One (iOne), the fastest growing and definitive digital platform for the New America, announced today that its flagship destinations will be re-imagined with new designs and features that inject new energy into the popular network of sites. Along with a new look and feel, each site will be rolling out more new content than ever, while offering advertisers additional opportunities to reach a diverse audience that spends twice as long on iOne than its competitors.
 The family of brands under the iOne umbrella garner nearly 30 million unique visitors per month (more than double from the same time last year), and reaches 12 million followers on social media. Today, HelloBeautiful.com, the definitive lifestyle destination for Black women is the first of the brands to unveil its new and improved platform, leading in the site flip. In coming months, re-launches will follow for TheUrbanDaily – where men go to get smart, timely and real urban pop-culture and entertainment news; GlobalGrind – an all-encompassing destination for Millennials of all races and backgrounds, that covers the “Hip” side of Pop culture across entertainment, celebrity, music, style & fashion and entrepreneurship; and NewsOne – which will continue to feature up to the minute, comprehensive coverage of newsworthy events relevant to Black Americans across the country and the world.
To enhance the experience for each user, this redesign will debut a variety of curated pages and branded logos that will be tailored to each iOne platform. Following each new website design all of the iOne properties will continue to deliver the content readers have come to value. New features on the new HelloBeautiful site include easy-to-use navigation so readers can quickly find the content they love; high-speed page load, larger high-res graphics; a sleeker color palette; and brand new exclusive content. This includes more video content than ever before, through the recently-launched HB Studios, dedicated to curating compelling original video series and documentaries for women of color. From the home page, to articles, photo galleries & video—the evolved user experience of the new HelloBeautiful.com provides the editors with the ability to promote and prioritize exactly the stories most important to the audience.
“The pulse of America lies with our audience,” said Interactive One President Tom Newman. “By refreshing and upgrading our flagship properties, we are adding new elements and content while maintaining the voice that this growing audience has come to love and appreciate.”
Additionally, with these re-launches will come new ways for advertisers to engage a diverse collection of Black, Latino and/or Millennial audiences. These offerings include:
- Expanded Native Advertising and Sponsored Content Opportunities – building off of the industry leading track record of successfully partnering with brands to create and distribute content;
- New Premium Ad Units – the launch of our new immersive iMpact ad unit: a full page rich media experience with numerous capabilities.
“Our content and advertising teams are working closely to ensure an optimal experience both for consumers visiting our suite of re-designed sites, and advertisers looking to engage with them,” said Interactive One SVP and Head of Sales Maria Weaver. “Cleaner, updated sites featuring more rich media and a look and feel that is less disruptive to advertisers, will result in higher viewability and the opportunity to authentically integrate brands into the consumer experience in a high-impact manner.”
About Interactive One
Interactive One is the fastest growing and definitive digital platform for the New America, reaching millions each month through its suite of online, mobile, social and content offerings. It owns and operates a number of branded destinations, including GlobalGrind (Millennials), HelloBeautiful (Women), NewsOne (Affluent), TheUrbanDaily (Men) and VidaToday (Latino), as well as social networking sites such as BlackPlanet, BlackPlanet RADIO and MiGente, and digital destinations for dozens of local radio stations. Interactive One was launched in 2008 by Radio One, Inc. [NASDAQ: ROIA and ROIAK, radio-one.com] to complement its existing portfolio of media companies targeting Black Americans. Since then, its news, entertainment, video and lifestyle content has driven its growth, with Interactive One reaching 29.4 million unique monthly visitors as of January 2015 (up 138 percent from the prior year). For more information, visit www.interactiveone.com.
Logo – http://photos.prnewswire.com/prnh/20141218/165356LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/interactive-one-re-launching-flagship-sites-with-new-content-and-advertising-offerings-targeting-diverse-black-latino-and-millennial-audiences-300091467.html
SOURCE Interactive One
Source: PR Newswire (June 1, 2015 – 8:10 AM EDT)News by QuoteMedia
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PRINCETON, N.J., June 1, 2015 — Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced the clearance of the Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to conduct a Phase 2 study of ADXS-HPV (ADXS11-001) alone or in combination with Incyte Corporation’s (NASDAQ: INCY) investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), for the treatment of Stage I-IIIb human papillomavirus (HPV)-associated cervical cancer.
In February 2015, Advaxis and Incyte entered into a non-exclusive clinical trial collaboration agreement to evaluate the combination of ADXS-HPV with epacadostat for the treatment of cervical cancer. The proposed Phase 2 protocol is designed as a multicenter, open-label, preoperative window-study designed to evaluate the safety and efficacy of ADXS-HPV as monotherapy and in combination with epacadostat in approximately 30 patients with Stage I-IIIb human papillomavirus (HPV)-associated cervical cancer. The results will be used to determine whether further clinical development of this combination is warranted.
“The FDA clearance of the ADXS-HPV plus epacadostat IND for HPV-associated early stage cervical cancer adds to Advaxis’s rapidly advancing pipeline in cervical cancer,” stated Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “Additionally, the acceptance of this IND strengthens our pipeline of combination studies involving our Lm-LLO platform and aligns our technology with another potentially best-in-class immunotherapy technology. We look forward to the initiation of this study with Incyte.”
“We are very pleased that the IND for this Phase 2 study has been cleared by the FDA,” said Rich Levy, MD, Chief Drug Development Officer at Incyte. “Epacadostat is currently in multiple combination proof-of-concept trials with immune checkpoint inhibitors, and this new study may provide us with important translational data for epacadostat in combination with an immunotherapeutic vaccine.”
About epacadostat (INCB24360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays, and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer types.
About ADXS-HPV
ADXS-HPV is Advaxis’s lead Lm-LLO immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer, and anal cancer. In cervical cancer, a completed Phase 2 study, ADXS-HPV demonstrated prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of this Lm-LLO immunotherapy. The U.S. Food and Drug Administration granted an orphan drug designation for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.
About Incyte Corporation
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics, primarily for oncology. For additional information on Incyte, please visit the Company’s website at www.incyte.com.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’s lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis’s ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.
Advaxis’s second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. (“Merck”), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis’s Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck’s PD-1 checkpoint inhibitor KEYTRUDA(R) (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.
Advaxis is also developing Lm-LLO immunotherapy ADXS-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-cHER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.
For more information about our cancer immunotherapies please visit www.advaxis.com.
Advaxis Forward-Looking Statements
This news release contains forward-looking statements of Advaxis, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapy, ADXS-HPV. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
Incyte Forward-Looking Statements
Except for the historical information set forth herein regarding Incyte, the matters set forth in this press release regarding Incyte contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the potential efficacy, safety and therapeutic value of Incyte’s epacadostat and its potential for treatment of Stage I-IIIb HPV-associated cervical cancer in combination with Advaxis’s ADXS-HPV compound; the design, safety, potential results and potential timing of the phase 2 study of ADXS-HPV in combination with epacadostat; and whether data from this phase 2 study will provide Incyte with translational data for epacadostat in combination with an immunotherapeutic vaccine.
These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to the efficacy or safety of epacadostat or Incyte’s other products and product candidates, the results of further research and development, the risks that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, other market or economic factors, competitive and technological advances, and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2015. Incyte disclaims any intent or obligation to update these forward-looking statements.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
SOURCE Advaxis, Inc.
Earnings Conference Call to be held on Thursday, June 4, 2015 at 5:00 am (Pacific) / 8:00 am (Eastern) / 8:00 pm (Beijing / Hong Kong)
JINJIANG, China, June 1, 2015 — China Ceramics Co., Ltd. (NASDAQ Global Market: CCCL) (“China Ceramics” or the “Company”), a leading Chinese manufacturer of ceramic tiles used for exterior siding and for interior flooring and design in residential and commercial buildings, today announced it will conduct a conference call at 8:00 am Eastern Time on Thursday, June 4, 2015 to discuss its financial results for the first quarter ended March 31, 2015.
The First Quarter 2015 Earnings Press Release will be available prior to the Company’s Earnings Call on the Investor Relations page of the China Ceramics’ website at: http://www.cceramics.com/Press-Releases.html.
To participate in the live conference call, please dial the following number five to ten minutes prior to the scheduled conference call time: 1-866-395-5819. International callers should dial 1-706-643-6986. In order to join this conference call, you will be required to provide the Conference ID Number 54205652.
If you are unable to participate in the call at this time, a replay will be available for 14 days starting on June 4, 2015, at 11:00 AM Eastern Time. To access the replay, please dial 1-855-859-2056, international callers dial +1-404-537-3406, using the Conference ID number 54205652.
About China Ceramics Co., Ltd
China Ceramics Co., Ltd. is a leading manufacturer of ceramic tiles in China. The Company’s ceramic tiles are used for exterior siding, interior flooring, and design in residential and commercial buildings. China Ceramics’ products, sold under the “Hengda” or “HD”, “Hengdeli” or “HDL”, the “TOERTO” and “WULIQIAO” brands, and the “Pottery Capital of Tang Dynasty” brands, are available in over 2,000 style, color and size combinations and are distributed through a network of exclusive distributors as well as directly to large property developers. For more information, please visit http://www.cceramics.com.
| Contact Information: |
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| China Ceramics Co., Ltd. |
Precept Investor Relations LLC |
| Edmund Hen, Chief Financial Officer |
David Rudnick |
| Email: info@cceramics.com |
Email: david.rudnick@preceptir.com |
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Phone: +1 917-864-8849 |
SHANGHAI, June 1, 2015 — SINA Corporation (NASDAQ: SINA) (“SINA” or the “Company”), a leading online media company serving China and the global Chinese communities, today announced that it has entered into a legally binding subscription agreement with Mr. Charles Chao, Chairman of SINA’s board of directors and Chief Executive Officer, for the issuance and sale of 11,000,000 newly issued ordinary shares of the Company to Mr. Chao. Pursuant to the agreement, Mr. Chao will subscribe for and purchase directly or through a special purpose vehicle beneficially owned and controlled by him, 11,000,000 newly issued ordinary shares of SINA for a total purchase price of approximately US$456 million in cash. The per share purchase price of US$41.49 represents the average closing trading price of SINA’s ordinary shares for the 30 trading days ended May 29, 2015 and is higher than the closing trading price on May 29, 2015, the last trading day before the signing of the subscription agreement. Mr. Chao has agreed to subject all the shares he or his affiliate will acquire in the transaction to a contractual lock-up restriction for six months after the closing. The closing is expected to take place upon satisfaction of customary closing conditions.
About SINA
We are an online media company serving China and the global Chinese communities. Our digital media network of SINA.com (portal), SINA mobile (mobile portal and mobile apps) and Weibo (social media) enables Internet users to access professional media and user generated content in multi-media formats from desktop personal computers and mobile devices and share their interests with friends and acquaintances.
SINA.com offers distinct and targeted professional content on each of its region-specific websites and a full range of complementary offerings. Our mobile portal, SINA.cn, provides news information and entertainment content from SINA.com customized for mobile users in WAP (mobile browser) and mobile application format. Weibo is a leading social media platform for people to create, distribute and discover Chinese-language content. Based on an open platform architecture, Weibo allows users to create and post feeds up to 140 Chinese characters and attach multi-media content, as well as access a wide range of organically and third-party developed applications, such as online games.
Through these properties and other product lines, we offer an array of online media and social media services to our users to create a rich canvas for businesses and advertisers to effectively connect and engage with their targeted audiences.
Safe Harbor Statement
This press release contains forward-looking statements. SINA may also make forward-looking statements in the Company’s periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “confidence,” “estimates” and similar statements. SINA assumes no obligation to update the forward-looking statements in this press release and elsewhere. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to SINA’s limited operating history in certain new businesses; condition of the global financial and credit market; the uncertain regulatory landscape in China; fluctuations in the Company’s quarterly operating results; the Company’s reliance on online advertising sales and value-added services for a majority of its revenues; failure to successfully develop, introduce, drive adoption of or monetize new features and products, including portal, Weibo and MVAS products; failure to enter and develop the small and medium enterprise market by the Company or through cooperation with other parties, such as Alibaba; the Company’s reliance on mobile operators in China to provide MVAS and changes in mobile operators’ policies for MVAS in China; failure to successfully integrate acquired businesses; risks associated with the Company’s investments, including equity pick-up and impairment; and failure to compete successfully against new entrants and established industry competitors. Further information regarding these and other risks is included in SINA’s annual report on Form 20-F for the year ended December 31, 2014 and other filings with the Securities and Exchange Commission.
Contact:
Investor Relations Department
SINA Corporation
Phone: (86-10) 5898-3336
Email: ir@staff.sina.com.cn
Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced that interim results from the company’s two Phase 1 clinical trials of entrectinib were presented in poster presentations, including a poster discussion, at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. Entrectinib is the company’s proprietary oral tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK.
“We were pleased to present the exciting data from our two Phase 1 clinical trials of entrectinib, which showed that this product candidate has been well tolerated to date with preliminary but promising signs of antitumor activity,” said Pratik Multani, M.D., Chief Medical Officer of Ignyta. “We have now determined the recommended Phase 2 dose of entrectinib on a body-surface-area basis, and we have demonstrated clinical activity in patients that would meet the anticipated eligibility criteria for our planned Phase 2 clinical trials. Across both studies, we observed responses in 10 of 11 patients meeting those criteria, for a response rate in those patients of 91%, including patients with each of Trk, ROS1 and ALK alterations and across multiple tumor histologies.”
The clinical trials included the ALKA-372-001 study and the STARTRK-1 study, which is the first of the “Studies Targeting Alterations Responsive to Targeted Receptor Kinase” inhibition. Both trials were designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, as well as preliminary anti-cancer activity, of single agent entrectinib in patients with solid tumors with the relevant molecular alterations: NTRK1 (encoding TrkA), ROS1 or ALK for ALKA-372-001 and NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK for STARTRK-1.
As of the May 1, 2015 data cut-off for the presentation, the findings showed:
- A total of 67 patients with a range of solid tumors had been dosed across both clinical trials;
- Entrectinib was well tolerated to date, with no treatment-related serious adverse events. Other safety findings included:
- In the ALKA-372-001 study, two Grade 3 treatment-related adverse events were observed: fatigue and muscle weakness, each of which subsided with dose reduction. The most frequent adverse events were paresthesia, nausea, myalgia, asthenia, dysgeusia, and vomiting;
- In the STARTRK-1 study, three Grade 3 treatment-related adverse events were observed: neutropenia, which resolved with dose reduction, and two dose-limiting toxicities of reversible cognitive impairment and fatigue, both of which occurred at 800 mg fixed dose and resolved upon study drug interruption. The most frequent adverse events were fatigue, dysgeusia, constipation, nausea, and paresthesia;
- Pharmacokinetic measurements showed dose-proportional increases across the daily dosing regimens evaluated, with a half-life compatible with once-daily dosing;
- The body surface area (BSA)-based recommended Phase 2 dose was determined to be 400 mg/m2 once per day (QD); both studies are continuing in order to determine a fixed daily dose regimen;
- 11 patients across both clinical trials met the company’s expected Phase 2 eligibility criteria, which include:
- Presence of NTRK1/2/3, ROS1 or ALK fusions, as opposed to other types of molecular alterations (e.g., SNPs, amplifications, deletions);
- ALK inhibitor and/or ROS1 inhibitor naïve; and
- Treatment at or above the recommended Phase 2 dose of 400 mg/m2;
- The response rate in the 11 patients that met these criteria across both studies was 91% (10 of 11 responses as assessed by the clinical sites), with 9 patients remaining on study treatment with durable responses of up to 16 treatment cycles. The responses included:
- 3 of 3 responses in patients with NTRK1/2/3 fusions, including patients with non-small cell lung cancer (NSCLC), colorectal cancer and acinic cell cancer;
- 5 of 6 responses, including one complete response, in patients with ROS1 fusions, all of which were in NSCLC; and
- 2 of 2 responses in patients with ALK fusions, including one NSCLC patient and one patient with another solid tumor.
On Monday, June 1, 2015, Ignyta will file a Form 8-K with the U.S. Securities and Exchange Commission (SEC) containing the materials presented at the ASCO Annual Meeting. The company’s SEC filings can be found on the company’s website at www.ignyta.com and on the SEC’s website at www.sec.gov.
About Ignyta, Inc.
Ignyta, Inc., located in San Diego, California, is a precision oncology biotechnology company pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. The company’s goal with this Rx/Dx approach is to discover, develop and commercialize new drugs that target activated cancer genes and pathways for the customized treatment of cancer, as well as novel chemotherapeutics that can potentially provide additional benefit to cancer patients. It aims to achieve this goal by pairing its product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients who are most likely to benefit from the precisely targeted drugs the company develops. For more information, please visit: www.ignyta.com.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to promising signs of antitumor activity and safety and other data from the Phase 1 clinical trials of entrectinib, and potential study designs and plans for future Phase 2 clinical trials of entrectinib. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the potential for results of current or future clinical trials of entrectinib or other product candidates to differ from preliminary or expected results; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta’s ability to develop, complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta’s plans to develop and commercialize its product candidates; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not be maintained or may not effectively protect a product from competition; the potential for the company to fail to maintain the CLIA registration of its diagnostic laboratory or to fail to achieve full CLIA accreditation of such laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent Quarterly Reports on Form 10-Q.
