• Affymax Inc., of Palo Alto, Calif., said it completed its four-trial Phase III program of Hematide and follow-up of patients with anemia due to chronic renal failure and expects to report top-line results in the second quarter. The Phase III program enrolled about 2,600 patients with chronic renal failure at about 400 sites in the U.S. and Europe. The program included two trials in dialysis patients and two in patients not on dialysis. Affymax and its partner, Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan, are developing Hematide and plan to co-commercialize the product once it is approved in the U.S.

• Biogen Idec, of Cambridge, Mass., and Swedish Orphan Biovitrum, of Stockholm, Sweden, said the first patient was dosed in an open-label, multicenter registration trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies' long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The trial, called the B-LONG study, will determine the efficacy of rFIXFc in the prevention and treatment of bleeding in about 75 previously-treated patients with severe hemophilia B.

• BN ImmunoTherapeutics Inc., of Mountainview Calif., and the Dana-Farber Cancer Institute, of Boston, reported that results of a Phase II trial demonstrated that patients with metastatic prostate cancer who received PROSTVAC-VF vaccine, a combination of two weakened poxviruses that have been genetically programmed to produce slightly irregular versions of prostate specific antigen, lived substantially longer than patients who received a placebo. The double-blind trial included 125 patients with metastatic prostate cancer who did not respond to standard, hormone-lowering therapy. At the three-year point after the study, 30 percent of the PROSTVAC-VF patients were alive vs. 17 percent of the control group. The median survival of the vaccine group was 24.5 months, compared with 16 months for the control group - an 8.5-month increase. Patients tolerated the vaccine well, with only a small number experiencing adverse effects, such as fatigue, fevers and nausea.

• Curemark LLC, of Rye, N.Y., has begun enrolling patients in Phase III trials for CM-AT, its autism treatment, at 10 sites across the country. CM-AT is based on research that showed enzyme deficiencies in autistic children resulted in an inability to digest protein, which affected the production of amino acids essential for brain function. A total of 170 children will be tested.

• Osiris Therapeutics Inc., of Columbia, Md., said it completed enrollment in a Phase II trial of Prochymal, an adult mesenchymal stem cell therapy, as a treatment for patients recently diagnosed with Type I diabetes. The firm said it received a $750,000 milestone payment from the Juvenile Diabetes Research Foundation, which was the fourth in a series of payments under the alliance. In total, 63 patients were treated at 20 leading centers in the double-blind, placebo-controlled trial. The FDA last July allowed Osiris to expand the trial to include pediatric patients.

• Transition Therapeutics Inc., of Toronto, said results from a randomized, double-blind, placebo-controlled, dose-ranging Phase II study showed that patients with Type II diabetes who received the highest daily dose of TT-223, a gastrin analogue, for 12 weeks and completed the entire study without adjusting their diabetes therapies experienced a statistically significant reduction in HbA1c of 1.13 percent six months after completing the drug, compared with 0.22 percent for patients on placebo.