• Avicena Group Inc., of Palo Alto, Calif., said a Phase II trial was initiated of two combination therapies incorporating ALS-08, a candidate for amyotrophic lateral sclerosis. Investigators will assess ALS-08 in separate combinations with celecoxib and minocycline. The six-month, multicenter, double-blind controlled trial will enroll up to 120 ALS patients, and the primary endpoint is the change in the revised ALS Functional Rating Scale.

• Baxter International Inc., of Deerfield, Ill., started a Phase I/II trial to test its vero-cell-based candidate H5N1 pandemic influenza vaccine. The study is being conducted with several hundred healthy adults in Austria and Singapore, using the fully inactivated wild-type H5N1 strain A/Vietnam/1203/2004. Four different antigen concentrations ranging from 3.75 mcg to 30 mcg are being tested in formulations with and without alum as adjuvant.

• Medivir AB, of Stockholm, Sweden, said Lipsovir (ME-609) has entered a Phase III study to prevent the development of labial herpes, or cold sores. The study will be conducted in the U.S. and Canada and will enroll more than 2,000 patients, with 1,270 in the treatment group. It should be complete by fall 2007, and could receive FDA approval by the end of 2008. The primary endpoint is the prevention of ulcerative lesions. Medivir expects to seek a marketing partner for the product.

• Nuvelo Inc., of San Carlos, Calif., said Phase II results demonstrating that alfimeprase can quickly restore function to occluded central venous access devices were published in the July 1 issue of the Journal of Clinical Oncology. The randomized, double-blind, controlled, dose-ranging study compared the safety and activity of three fixed doses of alfimeprase against the approved dose of CathfloActivase (alteplase) in 55 patients. Results demonstrated that at the highest dose of 3 mg, alfimeprase produced cumulative patency rates of 40 percent at five minutes, 50 percent at 15 minutes and 60 percent at 30 minutes and 120 minutes after the first dose, as well as 80 percent at 120 minutes after the second dose. CathfloActivase's patency rates were 0 percent, 0 percent, 23 percent and 46 percent, respectively. Based on the results, the company has started two Phase III trials evaluating the 3-mg dose of alfimeprase in catheter occlusion.

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