• Adolor Corp., of Exton, Pa., said its partner, GlaxoSmithKline plc, of London, completed enrollment in a Phase III program evaluating Entereg (alvimopan) in gastrointestinal adverse events caused by opioids used for persistent non-cancer pain. Enrollment of a Phase IIb study in cancer patients with persistent pain also has been completed. The companies are expected to submit applications for marketing approval in the U.S. and Europe in mid-2007.

• GeoVax Inc., of Atlanta, said the FDA approved an investigational new drug application for the company to start clinical trials with its AIDS vaccines. The trials, expected to begin this month, will administer two doses of GeoVax's DNA vaccine to prime the immune response, followed by two doses of its recombinant MVA vaccine to boost the response.

• Medarex Inc., of Princeton, N.J., and MedImmune Inc., of Gaithersburg, Md., began dosing patients in a Phase I trial of MEDI-545 for the potential treatment of systemic lupus erythematosus (SLE). The 45-patient trial will evaluate MEDI-545, a fully human antibody generated by Medarex's UltiMAb Human Antibody Development System, in patients who have mild SLE with lupus rash or skin lesions. Medarex and MedImmune agreed to collaborate in November 2004, with MedImmune accepting responsibility for all ongoing clinical development and Medarex receiving milestone payments and royalties. Medarex also has a co-development option in the U.S. (See BioWorld Today, Nov. 24, 2004.)

• Novacea Inc., of South San Francisco, initiated a pivotal Phase III study to evaluate its oral cancer drug, DN-101, in combination with Taxotere (docetaxel) vs. Taxotere alone in men with androgen-independent prostate cancer. The randomized study is expected to enroll about 900 patients and will have a primary endpoint of survival. Skeletal-related events and reduction of thromboembolic events will be measured as secondary endpoints. DN-101 is a dose-intense formulation of calcitriol and is designed to work by binding to the vitamin D receptor, triggering cellular pathways that might stop cancer cell growth.