• Acceleron Pharma Inc., of Cambridge, Mass., initiated a Phase I trial of ACE-011, a regenerative therapeutic for bone loss disease, particularly osteoporosis. The study will involve healthy postmenopausal women and will evaluate a single ascending dose for safety, tolerability and pharmacology properties. ACE-011 is based on the activin receptor IIa, and has demonstrated in preclinical models beneficial effects on both trabecular and cortical bone.

• Adnexus Therapeutics Inc., of Waltham, Mass., formerly Compound Therapeutics Inc., said an investigational new drug application for its anti-angiogenesis product, Angiocept, cleared FDA review and the company is in the process of beginning a Phase I trial in cancer patients. Angiocept (CT-322) is based on an AdNectin protein that specifically blocks human vascular endothelial growth factor receptor-2 (VEGFR-2), which is expressed on tumor cells. It was designed using Adnexus' PROfusion design engine.

• AEterna Zentaris Inc., of Quebec, said it would advance cetrorelix into Phase III for benign prostatic hyperplasia following a positive end-of-Phase II meeting with the FDA. The company plans to file an investigational new drug application in the next few months to begin that next phase of testing on the luteinizing hormone-releasing hormone antagonist.

• Arena Pharmaceuticals Inc., of San Diego, said Phase I data of APD125, an insomnia compound, demonstrated an excellent safety and tolerability profile and significantly improved sleep parameters in normal healthy volunteers, including slow wave, or deep, sleep associated with better sleep maintenance. The therapy did not impair next-day psychomotor skills or memory. Data were presented at the 20th anniversary meeting of the Associated Professional Sleep Societies in Salt Lake City.

• Athenagen Inc., of South San Francisco, said the FDA approved an investigational new drug application for ATG002, and it has completed preparation for a Phase I/II trial of the pro-angiogenesis topical wound healing agent in patients with diabetic foot ulcers. The trial will evaluate the nicotinic acetylcholine (nACh) receptor agonist at sites throughout the U.S. Eventually, the company plans to partner the program.

• Bioenvision Ltd., of Edinburgh, UK, reported data from its BIOV-121 Phase II study suggesting that single agent Evoltra (clofarabine) is as effective as intensive chemotherapy in elderly patients with adverse cytogenetics. Designed as a pivotal study, BIOV-121 tested clofarabine in acute myeloid leukemia patients older than 65, who are unfit for intensive chemotherapy. Data showed that in patients with an adverse cytogenetic profile, the overall response rate was 53 percent and the clinical response rate was 42 percent. Those results were presented at the 11th annual congress of the European Hematology Association meeting in Amsterdam, the Netherlands.

• Celtic Pharma Holdings LP, of New York, reported preliminary results of two Phase II studies of TA-CD, an immunotherapy vaccine for cocaine addiction, including data from a Phase IIa study in volunteers who reported a substantial reduction in the amount of cocaine used after developing good levels of anti-cocaine antibodies in their blood. A 114-patient Phase IIb trial, which looked at cocaine users who also were on methadone maintenance therapy for heroin addiction, did not achieve its primary endpoint in improving cocaine abstinence for three consecutive weeks, but results indicated that twice as many patients in the treatment group achieved 50 percent or greater increase in cocaine-free days. Data were presented at a National Institute on Drug Abuse meeting in Scottsdale, Ariz.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said results from a study evaluating the effect of its lead Ampakine drug, CX717, on cognitive performance and alertness across four nights of simulated night shift work found that the drug did not enhance cognitive performance relative to placebo, differing from earlier clinical results. The drug, however, was found to alter the recovery sleep architecture as measured by EEG polysomnography in a dose-related manner. The data sent Cortex's stock (AMEX:COR) down 58 cents Wednesday, or 16.9 percent, to close at $2.86.

• Elusys Therapeutics Inc., of Pine Brook, N.J., said the FDA granted orphan drug designation to its anthrax therapeutic, Anthim (ETI-204). The monoclonal antibody targets the protective antigen component of anthrax. In animal efficacy studies, it demonstrated protection against an anthrax spore challenge.

• Genentech Inc., of South San Francisco, said the FDA approved Avastin (bevacizumab) in combination with intravenous 5-fluorouracil-based chemotherapy for second-line metastatic colorectal cancer. The approval is based on Phase III data of 829 patients that showed that Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death, the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Avastin also is approved as a first-line treatment of metastatic colorectal cancer in combination with 5-FU, and it is in various Phase III trials as a treatment for kidney, breast, pancreatic, non-small-cell lung, prostate and ovarian cancers.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., reported results of a Phase I/II study showing that Velcade in combination with melphalan and prednisone appeared significantly superior to melphalan and prednisone alone in treating elderly patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplantation. Data showed an overall response rate of 89 percent, including a high complete and near complete response rate of 43 percent. Those results were published in Blood.

• Pharmos Corp., of Iselin, N.J., received approval from the Medicines and Healthcare Products Regulatory Agency and the local Ethics Committee in the UK to start a Phase IIa study of cannabinor (PRS-211,375), a CB2-selective synthetic cannabinoid drug candidate for the treatment of pain. The proof-of-concept trial will be conducted among healthy subjects experiencing pain following third molar dental extraction. It will include 100 male subjects and is expected to be completed in the third quarter.

• Zimmer Holdings Inc., of Warsaw, Ind., and ISTO Technologies Inc., of St. Louis, said the FDA approved an investigational new drug application for Neocartilage, a tissue-engineered living tissue graft designed to repair cartilage defects, restore joint function and relieve pain in the knee. The partners expect to receive approvals from individual clinical sites to proceed with initial implantations during the second half of this year.

No Comments