• Affiris, of Vienna, Austria, initiated a Phase I clinical trial of Alzheimer's vaccine Affitope AD01. In the trial, up to 24 Alzheimer's patients will receive four vaccinations over a three-month period, with results monitored for six months. The trial initiation triggers a venture capital payment from Munich, Germany-based MIG-Fonds.

• Cougar Biotechnology Inc., of Los Angeles, said the FDA has allowed its investigational new drug application for CB3304 in the treatment of relapsed or refractory multiple myeloma. The company expects to begin a Phase I trial soon. CB3304 is an orally active, opium-derived alkaloid that inhibits microtubule dynamics, blocks cell division and induces apoptosis.

• MedImmune Inc., a Gaithersburg, Md., unit of AstraZeneca plc, began dosing patients in a Phase Ib trial of MEDI-545, a fully human monoclonal antibody targeting interferon-alpha. The study is designed to evaluate the safety and tolerability of multiple doses in patients with systemic lupus erythematosus. The antibody separately is being evaluated in a single-dose Phase I trial in lupus patients and a Phase I study in patients with psoriasis. It plans to begin a trial in idiopathic inflammatory myopathies later this year. The antibody was generated with technology from Princeton, N.J.-based Medarex Inc.

• Metabolex Inc., of Hayward, Calif., completed enrollment in the 400-patient Phase II/III trial of MBX-102/JNJ 39659100 in Type II diabetes, triggering a milestone payment from worldwide development and commercialization partner Ortho-McNeil Inc., of Titusville, N.J. Data are expected early next year from the randomized, double-blind trial, which will compare the drug to Actos (pioglitazone, Takeda Pharmaceutical Co. Ltd. and Eli Lilly and Co.) and insulin. MBX-102/JNJ 39659100 is an insulin sensitizer but does not appear to affect genes associated with weight gain and edema. (See BioWorld Today, June 27, 2006.)

• Peplin Ltd., of Brisbane, Australia, said results from a Phase IIb trial of PEP005 topical in actinic keratosis indicate the drug was well-tolerated, with no drug-related serious adverse events, and resulted in statistically significant lesion clearance at all doses tested. When administered at a concentration of 0.025 percent for three consecutive days, PEP005 resulted in 56 percent of patients clearing three quarters or more of their lesions (p=0.0002). When administered at a concentration of 0.05 percent for three consecutive days, PEP005 resulted in 75 percent of patients clearing three quarters or more of their lesions (p<0.0001). Peplin intends to begin a Phase III trial in the first quarter of next year.

• UCB SA, of Brussels, Belgium, published previously released results of its two Phase III trials of Cimzia (certolizumab pegol, CDP 870) in Crohn's disease in the New England Journal of Medicine. In the Precise 1 trial, 23 percent of Cimzia patients and 16 percent of placebo patients responded to the drug at week 26 (p= 0.02). In the Precise 2 trial, 48 percent of Cimzia patients and 29 percent of placebo patients achieved disease remission at week 26 (p<0.001). Cimzia, a PEGylated anti-TNF alpha antibody, is under regulatory review in the U.S. and Europe.