• Cardium Therapeutics Inc., of San Diego, said it has started recruiting participants for its Phase IIb clinical trial, known as MATRIX, to evaluate the safety and efficacy of Excellarate, a DNA-based topical gel, for treatment of non-healing diabetic foot ulcers. The trial is a randomized, double-blind, placebo-controlled, comparator arm clinical trial is expected to enroll about 210 patients at about 25 U.S. sites. The study will enroll patients diagnosed with Type I or II diabetes with a non-healing foot ulcer present that have been present for at least six weeks and who have failed standard-of-care therapy. The five arms of the study will include standardized care, consisting of surgical debridement, dressing changes, and weight off-loading devices, one or two applications of placebo, and one or two applications of Excellarate. The study's primary endpoint is complete ulcer closure at 12 weeks or earlier. Secondary endpoints will be time to complete ulcer closure, change in ulcer area, durability of wound closure, and safety and tolerance.
• Ceregene Inc., of San Diego, said it has completed enrollment of its randomized, controlled, double-blind, Phase II clinical trial evaluating CERE-120, a gene-therapy product in development for the treatment of Parkinson's disease. The trial enrolled 58 patients with advanced Parkinson's disease across nine medical centers in the U.S. The company expects to announce results from the trial in late 2008. CERE-120 is designed to deliver the neurturin gene, a nervous-system growth factor with the ability to maintain the growth and normal function of dopamine-producing neurons which deteriorate in Parkinson's disease. The trial is supported in part by The Michael J. Fox Foundation for Parkinson's Research.
• Nymox Pharmaceutical Corp., of Harsbrouck, N.J., completed a two-year, 100-patient, Phase II follow-on study of NX-1207 for benign prostatic hyperplasia. Data are expected within two weeks.