|MAP Pharma migraine drug shows efficacy. SIGA completes fourth smallpox trial. After the bell: Molecular Insight surges on positive Phase IIa data|
|By BioMedReports.com Staff|
|Wednesday, 23 June 2010 19:32|
Below is a list of the companies that made news in the healthcare sector on Wednesday, June 23, 2010.
Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI) after the bell today presented positive data from a completed Phase IIa clinical study of Azedra, the Company's lead oncology therapeutic that targets neuroblastoma, one of the most common childhood cancer. Phase IIa data showed that the study successfully provided safety, toxicity and response data. The report indiscated that doses of 12 to 18mCi/kg were tolerated without dose limiting toxicity and was also active in tumors, without significant toxicity and showing promising responses.
According to the company the data support proceeding to a pivotal Phase 2 study utilizing the 18 mCi/kg administered therapeutic dose.
Shares of Molecular Insight shot up in the after hour session, jumping 23 cents or more than 14% to $1.83.
Pfizer Inc. (NYSE:PFE) announced today after the bell the suspension of the osteoarthritis clinical program for the investigational compound tanezumab following a request by the U.S. Food and Drug Administration (FDA). The worldwide suspension – which is effective immediately – follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab.
The clinical hold includes both the suspension of recruitment of new patients and the dosing of existing patients in the osteoarthritis program, as well as patients with osteoarthritis in other studies. The FDA has asked that, later this week, the company present its assessment of the potential implications of the adverse events in the osteoarthritis program for the other tanezumab clinical programs involving non-osteoporosis patients, which include patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy. The company is actively working with the FDA, to determine the appropriate course of action, which will serve the best interest of patients.
In news from earlier in the day:
MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) announced today it will present new analyses from the FREEDOM-301 Phase 3 clinical trial in a late breaker session at the 52nd Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, California on Friday, June 25. The presentation will show that the Company's investigational LEVADEX™ orally inhaled migraine therapy was effective irrespective of when it was administered during a migraine cycle. Separately, the Company also will present efficacy and safety analyses of a subgroup of migraine patients with concomitant asthma.
MAP Pharmaceuticals Inc. said Wednesday it will present a new analysis showing its inhaled drug Levadex was effective in a late-stage study at treating moderate-to-severe migraine pain even when taken up to eight hours after the attack's onset.
The company has already reported that the study met its key effectiveness and safety goals and a number of secondary goals in the study, called Freedom-301. Levadex, which is the inhaled form of an intravenous migraine treatment administered in hospitals and doctors' offices, worked when taken at the initial onset of the migraine and as late as eight hours later. The study involved 771 patients.
"Several published studies have shown that the efficacy of triptans is reduced significantly when treatment is delayed. However, many patients may be unable or unwilling to treat migraine early in an attack," said Stewart Tepper, M.D., director of research for the Center for Headache and Pain at the Cleveland Clinic. "Patients are looking to remedy this with a therapy that works when administered at any time during the migraine cycle."
Tepper and the company will present the new analysis at the 52nd annual Scientific Meeting of the American Headache Society in Los Angeles on Friday. Data also will show that Levadex was effective and well-tolerated in migraine patients with asthma.
Shares rose 53 cents to close Wednesday's trading session at $13.24.
SIGA Technologies, Inc. (Nasdaq:SIGA) announced today the successful completion of its fourth human clinical trial, supporting the safety and tolerability of the anticipated clinical dose of ST-246(R), SIGA's lead smallpox antiviral drug candidate. Analyses of the trial's results are consistent with findings from previous studies of ST-246 and together show that the drug will likely be found to be a safe and well-tolerated therapeutic for the treatment of orthopoxvirus infections.
"The results of this latest trial support our belief that ST-246 is likely to meet the FDA's requirements for being safe and well-tolerated. We are now in the planning stage for our expanded safety study of approximately 450 volunteers and are working with the FDA on establishing a protocol for the trial. Enrollment is expected to begin once the procedures have been determined," said Dr. Eric Rose, SIGA's Chief Executive Officer.
"As we move toward the goal of commercializing ST-246, our efforts are now directed towards completing the human and animal studies needed for regulatory approval. We are also advancing our efforts to obtain approval on additional indications for ST-246. Separately, we continue to make progress with our clinical pipeline of novel antivirals and apply for non-dilutive government grants and funding," Dr. Rose concluded.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense.
In May 2009, SIGA announced that it had submitted its response to the Biomedical Advance Research and Development Authority (BARDA) regarding the agency's outstanding RFP for the procurement of 1.7 million courses of a smallpox antiviral. The U.S. government considers the inhaled smallpox virus the single biggest biological threat which could be used against Americans via a terrorist attack.
Shares of SIGA rose 23 cents to $6.87.
Alnylam Biotherapeutics, a division of Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the presentation of new data at the IBC 6th Annual Cell Line Development and Engineering conference held in San Francisco, California from June 21 – 24, 2010. Alnylam established Alnylam Biotherapeutics to focus on the application of RNAi technology in manufacturing processes for biotherapeutics. The new results describe the discovery of highly effective novel delivery lipids (NDLs) that efficiently deliver siRNAs to manufacturing cell lines with no measurable adverse effects on cell density or viability. Furthermore, the NDLs demonstrate durable target gene silencing following a single dose, improved protein quality, and scalability to at least 40 liters.
IsoRay, Inc. (Amex: ISR) jumped more than 7% after the company announced today that it has completed a license agreement with Hologic, Inc. (NASDAQ:HOLX) for exclusive worldwide distribution rights to the GliaSite® radiation therapy system, the world's only FDA-cleared balloon catheter device used in the treatment of brain cancer. The system’s balloon catheter is a landmark technology that allows physicians to treat more patients than ever before with brachytherapy or internal radiation and provides important benefits over other radiation treatment options. The GliaSite system offers a number of advantages in brain cancer treatment. It places a specified high dose of a liquid radiation source in the areas most likely to contain cancer after brain tumor removal and is less likely to damage healthy brain tissue. It helps eliminate the ability for the tumor to reoccur, which in turn impacts patient longevity.
NexMed, Inc. (Nasdaq: NEXMD), today announced that Health Canada has confirmed acceptance of the Company’s CMC (Chemistry, Manufacturing and Controls) response for review. The Screening Acceptance Letter from Health Canada was issued in connection with its New Drug Submission for Vitaros®, the Company’s topical treatment for erectile dysfunction. The Acceptance Letter confirms that the CMC response filed by NexMed is acceptable for the final, 150-day review cycle, during which regulatory reviewers will determine the final approvability of the product for marketing in Canada. Based on the date of acceptance, a final approval decision is expected by the end of November 2010.
Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, stated, "Receipt of the Acceptance Letter marks another important milestone in the development history of Vitaros and we remain positive about the possibility for eventual product approval. As such, we anticipate utilizing our Canadian application as the basis for filing new marketing applications in other international markets."
NxStage Medical, Inc. (Nasdaq:NXTM), a leading manufacturer of innovative dialysis products, today announced that its Medisystems division has been awarded an exclusive five-year blood tubing supply contract with Atlantic Dialysis Management Services. Under the terms of the agreement, Atlantic Dialysis will now use Medisystems' Streamline® airless blood tubing set in all of its facilities.
"With high value products like Streamline, Medisystems is helping customers achieve both their clinical objectives and operational goals," said Mark Florence, Vice President & General Manager, Medisystems.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that Timothy P. Clackson, Ph.D. has been named the company's first President of Research and Development, effective immediately. Dr. Clackson, who joined ARIAD in 1994, also retains his position as Chief Scientific Officer.
Bioheart, Inc., (OTC Bulletin Board: BHRT) the company that helps monitor, diagnose and treat heart failure and other cardiovascular diseases announced that Mike Tomas has been appointed President and Chief Executive Officer and member of the Board of Directors effective immediately.
BioPharm Asia, Inc. (OTCBB: BFAR), a producer, distributor and retailer of medical products in China, announced last Friday that its wholly-owned subsidiary, China Northern Pharmacy Holding Group Limited, had entered into an agreement to acquire all of the outstanding shares of Beijing Zhihe Ruikang Hospital Management Ltd. a professional Chinese hospital management consulting group, for a consideration of RMB2,400,000 (approximately $350,000).
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced closing of a previously announced sale of an aggregate of $15 million of securities in a registered direct offering.
Cord Blood America, Inc. (OTC Bulletin Board: CBAI) is pleased to announce that Thomas Kolzau, Hamburg, Germany, an executive with a strong record of success in the medical, life sciences and bio/pharma industries, has been appointed Managing Director of Cord Blood America's 51 percent owned stellacure GmbH, the third largest cord blood banking service in Germany.
Kinetic Concepts, Inc. (NYSE: KCI) today announced that the High Court of Justice Chancery Division, Patents Court in the United Kingdom has found that Smith & Nephew plc's Renasys EZ and Go products (NYSE: SNN) infringe two KCI patents relating to negative pressure wound therapy.
Orthofix International N.V., (NASDAQ:OFIX) announced today that it will participate in the Wells Fargo Securities Healthcare Conference in Boston.
Phase Forward Incorporated (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced that, at a special meeting of its stockholders held on June 22, 2010, the holders of a majority of the outstanding shares of common stock of Phase Forward adopted the previously announced merger agreement dated as of April 15, 2010 among Phase Forward, Oracle Corporation ("Oracle") and Pine Acquisition Corporation, a Delaware corporation and a wholly-owned subsidiary of Oracle.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial-stage biotechnology company with a focus in oncology and hematology, today announced that it has appointed James E. Shields, a seasoned pharmaceutical sales executive with a proven track record of establishing and leading commercial operations, to the position of Senior Vice President and Chief Commercial Officer.
Stellar Pharmaceuticals Inc. (OTCBB:SLXCF) a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for intellectual property central to one of the Company's lead products, Uracyst® (a sterile sodium chondroitin sulfate solution, 2%), which is useful in the treatment of interstitial cystitis/painful bladder syndrome ("IC/PBS").
Tikcro Technologies Ltd. (OTC BB: TIKRF) today reported results for the first quarter ended March 31, 2010.
Valeant Pharmaceuticals International (NYSE:VRX) today announced that Oxsoralen-Ultra®, its therapy for severe psoriasis, is now available again in the United States on a limited supply basis.
VIVALIS (NYSE Euronext: VLS), a biopharmaceutical company, announced today that its research and development teams have moved into its new facility in Saint-Herblain Nantes, France.
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