• Aastrom Biosciences Inc., of Ann Arbor, Mich, has initiated its U.S. Phase IIb prospective, controlled, randomized, double-blind, multicenter clinical trial to treat patients suffering from peripheral arterial disease (PAD). The company will use its Tissue Repair Cell-based product to treat critical limb ischemia. Approximately 10 million people in the U.S. suffer from PAD, resulting in 100,000 amputations per year. The trial will consist of two patient groups totaling 120 people at about 20 sites to evaluate safety and efficacy.

• Advaxis Inc., of North Brunswick, N.J., finished recruiting patients in its Phase I/II trial of Lovaxin C, a Listeria-based immunotherapy for cervical cancer. A total of 15 patients have been dosed in the study, which is being conducted in Mexico, Serbia and Israel. The trial's objective was to establish a range of safe doses up to a maximally tolerated dose, which has been achieved. Advaxis plans to complete patient reporting in July, with results over the following two months, before submitting an investigational new drug application to conduct additional Phase II trials in the U.S.

• Celtic Pharmaceuticals Holdings, of Hamilton, Burmuda, has received investigational new drug application approval for TA-NIC, a vaccine for nicotine addiction. TA-NIC is designed to induce nicotine-specific antibodies, which bind to nicotine in the bloodstream, making them too large to cross the blood-brain barrier, thus reducing or eliminating the pleasurable stimulus. TA-NIC has been through two Phase I/II studies in the UK with no unexpected adverse events and there were indications of efficacy in the treated group compared to placebo.

• Cobalis Corp., of Irvine, Calif., said its independent contract research organization will need more time to combine Cobalis' three locked databases into a single database before unblinding and conducting the statistical analysis required to generate top-line results for Cobalis' twin pivotal Phase III Clinical Trials of PreHistin in seasonal allergic rhinitis. The company anticipates reporting its top-line results later in May.

• Pharmexa A/S, of Horsholm, Denmark, said its wholly owned U.S. subsidiary, Pharmexa-Epimmune, and partner Bavarian Nordic A/S, of Kvistgard, Denmark, initiated Phase I testing of the HIV vaccines EP1233 and MVA-BN Polytope in combination. The trial, which is expected to enroll up to 108 uninfected volunteers, is being conducted by the HIV Vaccine Trials Network which is supported through a cooperative agreement with the National Institute of Allergy and Infectious Diseases. Interim results are expected by the end of this year. Under the collaboration terms, Pharmexa and Bavarian Nordic share marketing rights for both vaccines.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., has been cleared by the FDA to begin its first Phase II clinical trial to test its sterile eye drop drug candidate Thymosin beta 4 for diabetic patients undergoing vitrectomy surgery. This will be its first phase II clinical trial outside of the dermal wound healing field and an expansion of its technology platform. The randomized, double-blind, placebo-controlled study will test several dosages in 48 diabetic patients at ophthalmic surgical centers and hospitals throughout the U.S.

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