|Icagen initiates trial with Pfizer. Peregrine surges on study update. FDA OKs Aeterna Zentaris study. After the bell: Incyte moves higher on Phase III results|
|By BioMedReports.com Staff|
|Monday, 20 December 2010 19:50|
After the bell Monday shares of Incyte Corporation (Nasdaq:INCY) jumped more than 5% after the company announced positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 in patients with myelofibrosis (MF), a rare blood cancer. The study is being conducted under a FDA Special Protocol Assessment (SPA) Agreement. COMFORT-I is a double-blind, placebo-controlled Phase III trial involving 309 patients. The company said that the study met its main goal and was consistent in its efficacy and safety profile. Patients that were treated showed a highly statistical response rate of 42% which compared to a less than 1% response in patients that were given a placebo. The drug will not require another late stage trial and Incyte remains on track to file for marketing approval in the Q2 2011.
After the bell, Incyte hit $16.00, up 82 cents from Mondays close of $5.18.
Shares of Sunesis Pharmaceuticals (Nasdaq:SNSS) rose Monday after an RBC Capital Markets analyst upgraded the stock, citing the value of its experimental leukemia treatment vosaroxin.
Myriad Genetics, Inc. (Nasdaq:MYGN) traded higher after the bell Monday. The company announced after the close the launch of PANEXIA, a predictive medicine product for hereditary pancreatic and related cancers. PANEXIA is a comprehensive analysis of the PALB2 and BRCA2 genes for assessing a person's risk of developing pancreatic cancer later in life. PANEXIA, Myriad's ninth molecular diagnostic product, is the second product launched by the Company this year.
"We are pleased to provide this important advancement for pancreatic cancer testing. Pancreatic cancer has long eluded significant clinical progress," said Mark Capone, President of Myriad Genetic Laboratories, Inc. "PANEXIA promises to provide healthcare providers, patients and their families with a better understanding of not only their pancreatic cancer risk, but possibly their breast, ovarian, or other related cancer risks."
Shares of Myriad were up 85 cents to $23.71 in extended trading.
Shares of Icagen, Inc. (Nasdaq:ICGN) made a monster move today after the company provided an update on its sodium channel program for pain and related disorders, which is being conducted in collaboration with Pfizer. As previously reported, the companies recently selected a candidate compound to advance into further clinical studies. Dosing of this candidate compound has now been initiated in a Phase I study in healthy volunteers.
The company reported that Pfizer will continue to fund the collaboration including all clinical studies s well as continued research and preclinical development of sodium channel targets. Icagen will receive milestones and sales based royalties while Pfizer has exclusive worldwide commercialization rights.
Investors applauded the news, sending shares of Icagen up 67 cents or 46.21% to $2.12.
Shares of Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), surged more than 34% today after announcing the completion of enrollment in the company's Phase II dose confirmation trial of Cotara in patients with recurrent glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single dose directly into the tumor, irradiating the tumor from the inside out, with minimal exposure to healthy tissue.
"As currently approved therapies have failed to improve overall survival for recurrent GBM patients, the interim overall survival reported to date from our Cotara trials has been quite remarkable and we are eager to advance our treatment into a registrational trial," said Joseph S. Shan, vice president of clinical and regulatory affairs at Peregrine. "We expect top-line data to be available by mid-year 2011 and plan to meet with the FDA to define the optimal registration pathway for Cotara."
Shares of Peregrine closed the day at $2.23, up 57 cents or 34.34%
As reported earlier today on BioMedReports, Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration and intends to accelerate its NDA for NORTHERA for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.
The FDA agreed that the proposed NDA for Northera could be submitted based on combined data from Chelsea's two completed Phase III studies in NOH, Study 301 and Study 302, without the need for any further efficacy studies. The agency did request and Chelsea agreed to supply top-line results from a QTc study at the time of the 90-day Safety Update and conduct a post-marketing study to evaluate the clinical pharmacology of Northera in renally impaired patients.
The ageement will allow Chelsea to file for approval sooner than expected. The stock shot up $1.68 or 28% on the news, closing Monday trading at $7.69.
Aeterna Zentaris Inc. (NASDAQ:AEZS) traded higher today after the company announced that it has reached agreement with the FDA on a Special Protocol Assessment for Solorel, aka; AEZS-130, macimorelin. The SPA will enable the company to complete the ongoing registration study required to gain approval as a diagnostic test for Adult Growth Hormone Deficiency (AGHD). AGHD affects 35,000 in the U.S. with symptoms such as low energy, decreased strength, increased weight, emotional changes and impaired sleep.
"We are pleased with the agreement with the FDA and now look forward to the completion of the Phase 3 trial with Solorel and the NDA filing in 2011 for use as a diagnostic test in AGHD", stated Juergen Engel, Ph.D., President and CEO at Aeterna Zentaris. "In line with our innovative approach, Solorel could become the first approved oral test for the diagnosis of AGHD, providing patients with a potentially safer, accurate and more convenient alternative to the current injectable tests."
AEterna plans to file a New Drug Application in 2011. If Solorel is ultimately approved, it could become the first oral test for the diagnosis of AGHD, the company said. Current diagnostic methods use injections, are complicated and can results in severe side effects.
Shares of Aeterna Zentaris closed the day at $1.96, up 12 cents or 6.52%
Gilead Sciences, Inc. (Nasdaq:GILD) announced that it will acquire Arresto Biosciences, Inc., a privately-held, development-stage biotechnology company focused on medicines to treat fibrotic diseases and cancer, for $225 million and potential future payments based on achievement of certain sales levels.
Idera Pharmaceuticals, Inc. (Nasdaq:IDRA) announced today preliminary data from a 4-week dose-ranging Phase 1 clinical trial of IMO-2125 in combination with ribavirin in 60 treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. In the trial, treatment with IMO-2125 in combination with ribavirin was well tolerated and achieved substantial decline in virus levels at two days after the first dose of IMO-2125 and after four weeks of treatment. IMO-2125 is a Toll-like Receptor 9 (TLR9) agonist which stimulates production of natural interferons and other antiviral cytokines.
"In this study, IMO-2125 plus ribavirin was well tolerated with no treatment-related discontinuations, and demonstrated substantial antiviral activity," said Robert Arbeit, M.D., Vice President of Clinical Development at Idera. "We believe that IMO-2125 may provide an alternative immune modulatory component to pegylated interferons in the anticipated HCV therapy combinations using direct-acting antivirals. In this treatment scenario, effective stimulation of the host immune system through TLR activation could minimize the risk of viral breakthrough."
King Pharmaceuticals®, Inc. (NYSE:KG) and Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today announced that King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug Administration (FDA), including a request for priority review classification. ACUROX® is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain. ACUROX® utilizes Acura's patented Aversion® Technology which is designed to deter opioid abuse by intravenous injection of dissolved tablets and nasal snorting of crushed tablets. ACUROX® does not contain niacin. A separate NDA submission for ACUROX® with Niacin Tablets is subject to an FDA Complete Response Letter. Further details on the response to this FDA action letter will be provided at a later date.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX) an integrated specialty pharmaceutical company focused primarily on the pediatric market, today announced the establishment of a new joint venture with SEEK, a leading United Kingdom private drug-discovery group. The joint venture will undertake the late-stage development and registration of BC1036, a first-in-class antitussive drug designed to address the serious need for a safer and more effective, non-opioid treatment for persistent cough. Both parties also licensed or assigned all of their theobromine intellectual property to the joint venture.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it was awarded patent 4,546,454 entitled, "Antisense Oligonucleotides that Inhibit Expression of HIF-1," by the Japanese Patent Office.
Spectrum Pharmaceuticals (NasdaqGM:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that effective January 3, 2011, it will begin trading on the NASDAQ Global Select Market. The NASDAQ Global Select Market is the highest NASDAQ listing tier based on financial and liquidity criteria. Prior to the effectiveness of this change in the New Year, shares of Spectrum Pharmaceuticals will continue to be traded on the NASDAQ Global Market.
VIVUS, Inc. (Nasdaq:VVUS) today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA, Controlled Release Capsules in the European Union (EU). The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet.
Allied Healthcare International Inc. (NASDAQ:AHCI), a leading provider of flexible healthcare staffing services in the United Kingdom, announced today that Sandy Young, the Company's Chief Executive Officer, will be presenting at the Sidoti Semiannual Micro-Cap Conference on January 10, 2011 at the Grand Hyatt New York Hotel in NYC.
Amarillo Biosciences, Inc. (ABI) (OTCBB:AMAR) today announced that a clinical trial of ABI's interferon-alpha lozenges for the treatment of influenza will be launched in Taiwan in 2011.