• Cytogen Corp., of Princeton, N.J., filed an investigational new drug application with the FDA for CYT-500, its lead therapeutic candidate targeting prostate-specific membrane antigen (PSMA). The company expects to begin the first U.S. Phase I trial in patients with hormone-refractory prostate cancer. CYT-500, which is designed to enable targeted delivery of a cytotoxic agent to PSMA-expressing cells, is fully owned by Cytogen.

• Fibrex Medical Inc., of Vienna, Austria, completed an initial human study of its lead product, the anti-inflammatory peptide FX06. The product is being developed to prevent reperfusion injury, and the Phase I data confirmed the safety profile seen in animal studies. The company plans to begin this quarter a European-based Phase II study in 140 patients. Results will be available in about a year.

• Immune Response Corp., of Carlsbad, Calif., said results of a clinical trial demonstrated that its T-cell receptor peptide vaccine candidate, NeuroVax, induced disease-specific immune responses, with 14 of 17 patients showing increased FOXP3+ mRNA expression over baseline at 52 weeks. In a number of patients, FOXP3 message and protein expression became higher than those in healthy controls. The data were presented at the American Academy of Neurology meeting in San Diego.

• Lilly ICOS LLC, a joint venture between ICOS Corp., of Bothell, Wash., and Eli Lilly and Co., of Indianapolis, said data reported at the Congress of the European Association of Urology show that when 140 patients who had erectile dysfunction secondary to traumatic spinal cord injury were treated with Cialis (tadalafil), their International Index of Erectile Function Domain scores improved from a mean baseline score of 13.5 to 22.6 at endpoint. That compares with 44 placebo-treated patients with a mean baseline score of 13.0 and 13.6 at endpoint. It generally is considered that an improvement of four points or more reflects a clinically meaningful change, the company said, adding that 54 percent of spinal cord injury patients treated with Cialis reported normal erectile function at the end of treatment.

• Medicure Inc., of Winnipeg, Mannitoba, reported positive 90-day results from a Phase II study of its lead cardioprotective product, MC-1, in 902 patients who underwent coronary artery bypass graft (CABG) surgery. Notably, the three-month duration showed that 30-day results - the trial's primary endpoint - were maintained. That endpoint was a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke up to that point, and after 30 days, a 250-mg dose of MC-1 had a 37.2 percent reduction in that composite (p=0.028).

• Pozen Inc., of Chapel Hill, N.C., and partner London-based GlaxoSmithKline plc reported data showing that a single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT technology and naproxen sodium 500 mg demonstrated superior results in treating acute migraine pain compared to sumatriptan alone or placebo. The data were presented at the American Academy of Neurology meeting in San Diego.

• Sangamo BioSciences Inc., of San Diego, reported positive results from the Phase I trial of SB-509, its ZFP therapeutic for diabetic neuropathy. All of the safety endpoints of the 12-patients study were met, and about 50 percent of subjects who received a single treatment showed improvement in pain, numbness and neurological symptoms. The data were presented at the American Academy of Neurology meeting in San Diego.

• Tigris Pharmaceuticals Inc., of Bonita Springs, Fla., initiated a Phase II trial of A-007 in 250 patients with high-grade cervical intraepithelial neoplasia. The trial's primary objective is to determine the pathological response of the A-007, a self-administered intravaginal gel, as compared to placebo, in the treatment of high-grade CIN, while secondary objectives include safety, human papillomavirus eradication and measurement of immunologic parameters. Results are expected in 2007.