• Baxter International Inc., of Deerfield, Ill., announced final Phase I/II data for its adjuvant-free investigational pandemic H5N1 influenza vaccine. The Phase I/II study indicated that Baxter's H5N1 candidate vaccine is highly immunogenic at low doses, and induces substantial levels of cross-immunity against widely divergent H5N1 strains. The company plans to initiate an open-label, multicenter Phase III trial of the candidate vaccine in Europe to evaluate the safety and efficacy of the candidate vaccine. Vaccinations will begin in the first half of this year, and results of the Phase III trial are scheduled to be available by the end of 2007.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., has initiated enrollment in a 40 mg cohort in its Phase II double-blind trial to determine the appropriate dose for Phase III testing of incyclinide in the treatment of acne. The 40 mg cohort will enroll 100 patients with moderate to severe acne at 13 investigational centers across the U.S. The placebo-controlled study will evaluate a daily 40 mg dose of incyclinide over a 12-week period.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said that the first patient was enrolled in an open-label, nonrandomized study of EZN-2968, a Hypoxia-inducible factor-1 alpha or HIF-1 alpha antagonist, for advanced solid tumors or lymphoma. The Phase I trial expects to enroll between 30 and 40 participants to evaluate the safety, tolerability and pharmacokinetics of the drug. Enzon licensed EZN-2968 in July from Santaris Pharma AS, of Horsholm, Denmark.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., has started a Phase IIb trial to evaluate a selective 5-HT1A partial agonist, PRX-00023, in adults with major depressive disorder (MDD) with an additional diagnosis of anxiety. The randomized, double-blind, placebo-controlled trial will enroll about 330 participants who will receive the drug twice a day for eight weeks and will measure changes in the Hamilton Anxiety Score, the Clinical Global Impressions Improvement Scale and the Clinical Global Severity of Illness Scale. The dosage will start with 40 mg twice daily and will be increased, if tolerated, to a maximum dosage of 120 mg twice daily within the first week. Data are expected in 2008.