• BioMS Medical Corp., of Edmonton, Alberta, said a monitoring board recommended continuation of its pivotal Phase II/III MAESTRO-01 trial of MBP8298 in patients with secondary progressive multiple sclerosis. The move followed a planned interim safety analysis of the first 100 patients in the 550-patient study who completed 12 months of treatment. The next interim analysis, targeted for mid-2008, will look at both safety and efficacy in the first 200 patients who have completed 24 months of treatment. The primary endpoint of the trial, in Canada and Europe, is an increase in the time to disease progression, in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. The trial is one of three ongoing late-stage studies of MBP8298 in MS.

• Callisto Pharmaceuticals Inc., of New York, said it intends to move Guanilib (SP304) into clinical trials in ulcerative colitis. The decision was based on data from animal models showing reduced gastrointestinal inflammation. Guanilib is an oral agent designed to mimic uroguanylin, a hormone normally produced in the body's intestinal tract. The timing on planned studies was not disclosed.

• Cleveland BioLabs Inc., of Cleveland, said its Phase II efficacy trial of Curaxin CBLC102 in advanced, hormone-refractory prostate cancer progressed to the next phase. The move was triggered by the initial cohorts of patients not exceeding a certain threshold related to adverse events. The trial will start with 15 patients, and would add 13 more once a PSA response is achieved in at least one patient. The trial is expected to total 31 patients and last two years. Primary endpoints are reduction in PSA levels, reduction in tumor size and disease-free survival. The oral agent, which has been used to treat malaria, is believed to target p53 and NF-kB. The company plans to start additional Phase II studies of Curaxin CBLC102 this year in renal cell carcinoma and multiple myeloma.