• AVI BioPharma Inc., of Portland, Ore., dosed the first patient in a proof-of-concept trial of AVI-4658 in Duchenne's muscular dystrophy. The study is expected to include up to nine boys with DMD, each of whom will receive a single intramuscular administration of the drug. Two to three weeks following the injection, the muscle will be biopsied and examined for molecular evidence of corrected dystrophin reduction. AVI-4658 is based on the company's ESPRIT (Exon Skipping Pre-RNA Interference Technology) drug platform.

• Elan Corp., of Dublin, Ireland, and Wyeth Pharmaceuticals, of Collegeville, Pa., dosed the first patient in a global Phase III program for bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer's disease. The Phase III program is expected to include a total of four studies in about 4,000 patients, to be distributed equally between North America and the rest of the world. Each of the studies will have co-primary efficacy endpoints - one cognitive and one functional - and patients are expected to participate for 18 months, with evaluation methods including neuropsychiatric scales and imaging and biomarker analysis. Bapineuzumab has fast-track designation in the U.S.

• Sinovac Biotech Ltd., of Beijing, reported positive top-line results from its Phase II trial of a pandemic influenza (H5N1) whole viron inactivated vaccine. The study included 402 volunteers who were vaccinated with two doses each of 5 mcg, 10 mcg or 15 mcg, and preliminary data suggested that each of those dosages can induce varying degrees of immune response. In particular, the anti-HI seroconversion rate, the increasing GMT and protection rate of the H5N1 whole viron inactivated vaccines for the 10-mcg and 15-mcg dosages reached the standards set by the European Medicines Agency for seasonal flu vaccines. Results did not show any serious adverse reaction among volunteers. Sinovac also recently completed a Phase I trial of the split H5N1 vaccine, which showed that vaccinations on children, adults and the elderly were found to be safe.

• Transition Therapeutics Inc., of Toronto, and Elan Corp., of Dublin, Ireland, dosed the first patient in a Phase II study of ELND005 (AZD-103) in patients with Alzheimer's disease. The study is expected to evaluate the drug in about 340 patients with mild to moderate forms of the disease. It will evaluate both cognitive and functional endpoints, and each patient's participation is planned to last about 18 months. The start of the Phase II study triggered a $5 million milestone payment from Elan to Transition, as part of the companies' potential $200 million agreement signed in September 2006. Transition also said it will issue the former shareholders of Toronto-based Ellipsis Neurotherapeutics Inc. 174,123 common shares of Transition priced at $10.86 each. Transition acquired ELND005 from its March 2006 buyout of Ellipsis. (See BioWorld Today, Sept. 28, 2006.)

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