• AVI BioPharma Inc., of Portland, Ore., started a clinical program for the treatment of Duchenne's muscular dystrophy using its ESPRIT (Exon Skipping Pre-RNA Interference Technology) exon-skipping technology. The program is based on positive preclinical data amassed over the past two years, including collaborator studies published in the October 2006 issue of Neuromuscular Disorders and the February 2006 issue of Nature Medicine. The technology is designed to delete disease-causing gene sequences in patients with certain genetic diseases, including DMD.

• BioTime Inc., of Emeryville, Calif., said a Japanese Phase II trial is under way to test Hextend's ability to restore and maintain plasma volume longer than plasma volume expanders currently marketed there. The study is being conducted by Summit Pharmaceuticals International Corp., of Tokyo, under a license agreement with BioTime. Summit is co-developing Hextend for the Japanese market with Maruishi Pharmaceutical Co. Ltd., of Osaka, and both Maruishi and Summit have the right to co-market Hextend. Summit expects Phase III studies to begin in 2008.

• Cardium Therapeutics Inc., of San Diego, said that Generx (alferminogene tadenovec) is to be advanced to a Phase III trial in women as a potential treatment for myocardial ischemia, following an end-of-Phase II meeting with the FDA. The trial is expected to start in the first quarter of next year and enroll about 300 women.

• MethylGene Inc., of Montreal, and partner, Pharmion Corp., of Boulder, Colo., initiated a Phase II trial with an isotype-specific histone deacetylase (HDAC) inhibitor, MGCD0103, in patients with high-risk myelodysplastic syndromes or relapsed or refractory acute myelogenous leukemia. The study will enroll up to 82 patients, who will receive MGCD0103 orally three times per week for four weeks without interruption, at a flat-dose of 110 mg. The key objective will be to determine the drug's efficacy in those patient populations, and secondary objectives include determining the safety profile and assessing biomarkers and predictive markers for the drug. The trial is expected to take up to 24 months.

• Omrix Biopharmaceuticals Inc., of New York, started a Phase I trial with its Fibrin Patch product for the management and rapid control of bleeding including severe bleeding in surgery.

• Othera Pharmaceuticals, of Exton, Pa., enrolled its first patient in a Phase II trial of OT-551, a topical eye drop for patients with geographic atrophy, an advanced form of dry-eye age-related macular degeneration. The study is designed to evaluate OT-551's potential to reduce the loss in central vision acuity and to slow enlargement of the atrophic area in the macula. Othera has plans to initiate a larger Phase II study of OT-551 in 2007.

• Samaritan Pharmaceuticals Inc., of Las Vegas, said the FDA requested additional information on the company's investigational new drug application for Caprospinol prior to Phase I testing. Caprospinol is an Alzheimer's drug candidate designed to clear beta-amyloid plaques from the brain.

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