DMC Committee Recommends Continued Enrollment in Study of Oncolytics' REOLYSIN®; Onyx Gets Positive Vote for Kyprolis™ by ODAC Print E-mail
By Staff and Wire Reports   
Wednesday, 20 June 2012 19:14

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 20, 2012.

Oncolytics Biotech Inc. (NASDAQ:ONCY) announced the Company’s independent Data Monitoring Committee (DMC) has reviewed the safety data for the first stage of its Phase III trial of REOLYSIN in combination with carboplatin and paclitaxel for the treatment of head and neck cancers (REO 018). Based on the review of the safety data the DMC has recommended that enrollment continue in the study.

“The safety data from the first stage of the Phase III study met our expectations and confirms the positive safety data from our other clinical studies using REOLYSIN,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We will now focus our time and attention on conducting the statistical analysis of the efficacy of the first stage’s patient population, which is forthcoming.”

The study design stipulates that the study will proceed to full enrollment in Stage 2 (ranging from 100 to 400 additional patients) provided that the DMC concludes that safety data in Stage 1 is acceptable for continuation to Stage 2, and an independent statistical analysis of Progression-Free Survival (PFS, a measure of efficacy) in Stage 1 predicts probability of success in Stage 2. The data collection for this analysis is currently being performed.

The safety analysis was performed on the 80 patients enrolled in Stage 1 of the study, once every patient had sufficient follow up after starting treatment on the study (six weeks). The statistical analysis will be performed once every patient has had sufficient follow up after starting treatment (12 weeks) to determine potential differences in PFS between the control and test arms of the study.

The study is a randomized, two-arm, double-blind, multi-centre, two-stage, adaptive Phase III trial assessing the intravenous administration of REOLYSIN with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. On April 2, 2012, the Company announced that enrollment in the non-adaptive, 80-patient first stage of the trial had been completed.

Enrollment is currently underway in the adaptive second stage, which is designed to enroll between 100 and 400 patients. This adaptive trial design allows data evolution to determine if the probably of reaching a statically significant endpoint has been achieved. The trial is currently being conducted at more than 80 centres in 14 countries in North America and Europe, including the United States following an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process with respect to the trial's design.


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Onyx Pharmaceuticals (Nasdaq: ONXX)
announced U.S. FDA Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis™ (proposed brand name for carfilzomib). Onyx is developing Kyprolis for use in multiple myeloma across a variety of treatment lines.

Onyx has also announced that NASDAQ has halted trading of the company's common stock.



Also Wednesday:




AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX)
, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Patent and Trademark Office (USPTO) issued AcelRx Patent Number 8,202,535 entitled "Small-Volume Oral Transmucosal Dosage Forms."  

A.P. Pharma, Inc. (OTCBB: APPA.OB)
, a specialty pharmaceutical company, today announced that the Company will present patient-satisfaction data from its Phase 3 trial of APF530 at the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) International Symposium.

Bristol-Myers Squibb Company (NYSE: BMY)
and Emory University today announced the formation of a strategic partnership to conduct clinical trials involving Bristol-Myers Squibb’s investigational compounds.

China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP)
, a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced financial results for the three months ended April 30, 2012.

CytoSorbents Corporation (OTCBB: CTSO)
, a critical care-focused company using blood purification to modulate the immune system and prevent or treat organ failure caused by life-threatening illnesses, today announced the pending departure of David Lamadrid, Chief Financial Officer, effective July 11, 2012 following over 12 years of service to the Company due to personal reasons.

EasyMed Services, Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6)
("EasyMed" or the "Company") announces the appointment of Tejinder Sahota as CEO. M. Sahota has had a long and illustrious career as a Management Consultant with global giant Accenture.

GE Healthcare, a unit of General Electric Company (NYSE:GE), announced today, in collaboration with Saint Luke’s Neuroscience Institute (SLNI) in Kansas City, Mo., the first healthymagination care area validation for stroke.

GenMark Diagnostics, Inc. (NASDAQ: GNMK)
, today announced the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $4.20 per share.

InterMune, Inc. (NASDAQ: ITMN)
today announced that on June 19, 2012, the company completed the previously announced sale of its rights to Actimmune® (interferon gamma-1b) to Vidara Therapeutics International Limited (Vidara).

Life Technologies Corporation (NASDAQ: LIFE) today announced a collaboration with the University of North Texas Health Science Center's  Institute of Applied Genetics utilizing the company's Ion Personal Genome Machine® (PGM™) system to further their research, development, and implementation of best technologies in forensic DNA analyses.

Life Technologies Corporation (NASDAQ: LIFE) and Boston Children's Hospital, home of the world's largest pediatric research enterprise, today announced a research and development collaboration to develop an end-to-end genetic sequencing lab workflow based on Life Technologies' Ion Proton™ Sequencer.

Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the developer of BiopumpTM, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that its INFRADURE™ Biopump has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for the treatment of hepatitis D. INFRADURE is the version of Medgenics’ Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis.

CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to modulate the immune system and prevent or treat organ failure caused by life-threatening illnesses, today announced the pending departure of David Lamadrid, Chief Financial Officer, effective July 11, 2012 following over 12 years of service to the Company due to personal reasons.

Oncolytics Biotech Inc. (TSX: ONC) NASDAQ: ONCY) announced today that the Company's independent Data Monitoring Committee (DMC) has reviewed the safety data for the first stage of its Phase III trial of REOLYSIN in combination with carboplatin and paclitaxel for the treatment of head and neck cancers (REO 018).

Pfizer Inc (NYSE: PFE)
issued the following statement in response to today’s Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) vote to recommend the use of Pfizer’s Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for adults 19 years of age and older with immunocompromising conditions.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) is reporting preliminary results from a double-masked, vehicle-controlled, physician-sponsored Phase 2 clinical trial evaluating RGN-259 for the treatment of severe dry eye.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF)
today announced that it has acquired the Canadian rights for Collatamp G®from Theramed Corporation.

Stellar Biotechnologies, Inc. (TSX VENTURE: KLH) (PINKSHEETS: SBOTF) (FRANKFURT: RBT) is pleased to announce that Stellar scientists will be presenting new KLH science at the ICAAC 2012 Conference (the meeting of the American Society for Microbiology -- "the world's premier international conference on antimicrobial agents and infectious diseases" -- http://www.icaac.org/) in San Francisco on September 9 - 12 in a poster presentation titled "Keyhole Limpet Hemocyanin (KLH) N-Glycans Share Similar Structural Features with Saccharides of Schistosoma, Trypanosoma, Leishmania, Cryptococcus, Apergillis, Candida, E. coli, Salmonella, Clostridium and Hepatitis C virus (HCV)."

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that Dipak Panigrahi, MS, MD, has joined the company as Vice President, Medical Affairs, a newly created position to expand our activity in this area.

Viral Genetics (Pinksheets: VRAL), through its majority owned subsidiary VG Energy, is now verifying the chemical activity in industrial scale batches of LipidMax™ in response to demand for the product from research institutes and from industry.




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