• AVI BioPharma, of Portland, Ore., announced a multicenter, double-blind, randomized, placebo-controlled study of AVI-5126, a new generation of the Neugene antisense drug, for coronary vascular disease. AVI-5126 silences a gene known as c-myc, involved in cardiovascular restenosis. The study will evaluate the therapeutic benefit of exposing a saphenous vein to AVI-5126 before connecting it to the coronary artery circulation of patients undergoing coronary artery bypass grafts. Initial patient recruitment for Phase Ib/II will start in November.

• Avicena Group Inc., of Palo Alto, Calif., completed patient enrollment for the first stage of a Phase II trial for ALS-08 for amyotrophic lateral sclerosis. The drug will be assessed in separate combinations with minocycline and celecoxib for efficacy, safety and tolerability, using the revised ALS Functional Rating Scale. The study is supported by the ALS Association, Ride for Life and the Russ Bowen and Spina Family foundations.

• Bionovo Inc., of Emeryville, Calif., completed enrollment of 184 patients in a Phase II trial of MF101, an oral estrogen receptor beta (ER-beta) selective drug for hot flashes and other symptoms of menopause. The trial will evaluate the efficacy of MF101 on actual and perceived relief from menopausal symptoms. Data from the study are expected in April 2007.

• NeurogesX Inc., of San Carlos, Calif., reported that a Phase III trial of Transacin (NGX-4010) met its primary endpoint of reducing pain after a single, one-hour treatment in patients with post-herpetic neuralgia (p=0.001). A reduction in pain also was noted during the first week following treatment (p=0.04) and was maintained throughout the 12-week study. The 402-patient trial evaluated Transacin, a high-concentration trans-capsaicin dermal patch, compared to a low-concentration capsaicin control patch. NeurogesX previously reported positive Phase III data with Transacin in HIV-associated neuropathy, which along with the PHN data, will form the basis of an MAA filing in the first half of 2007. The company currently is enrolling confirmatory Phase III studies in both indications to support an NDA in mid-2008.

• YM BioSciences Inc., of Mississauga, Ontario, announced the results from a Phase IIb trial open-label portion for AerolEF, an inhaled liposome-encapsulated fentanyl, for moderate to severe postoperative pain. The results were presented at the American Society of Anesthesiologists Annual Meeting in Chicago. A majority of the patients achieved effective relief for moderate to severe acute post-surgical pain by self-titrating the drug.

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