• Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., initiated an open-label, randomized, Phase II trial of sapacitabine in previously untreated or first relapsing elderly patients with acute myeloid leukemia. Sapacitabine, an oral nucleoside analogue, also is being studied in Phase II trials for cutaneous T-cell lymphoma.

• LifeCycle Pharma AS, of Horsholm, Denmark, initiated a Phase II trial of LCP-Tacro in autoimmune hepatitis. The trial will compare prednisone plus LCP-Tacro, a once-daily tablet version of tacrolimus, to prednisone plus azathioprine, the standard of care. Data from the open-label, randomized, 60-patient trial are expected in the first half of 2009.

• Neopharm Inc., of Waukegan, Ill., filed an investigational new drug application with the FDA for a liposomal formulation of docetaxel and is planning a Phase I trial in solid tumors. The company also is discussing a regulatory path with the FDA for its liposomal formulation of paclitaxel, although a Phase II trial with its liposomal formulation of irinotecan failed earlier this year. Shares of Neopharm (NASDAQ:NEOL) rose 5 cents to close at 64 cents on Wednesday.