• Bioniche Life Sciences Inc., of Belleville, Ontario, said the FDA granted fast-track status for its Mycobacterial Cell Wall-DNA Complex (Urocidin) in patients with non-muscle invasive bladder cancer who are refractory to Bacillus Calmette-Guerin, the standard therapy. The product is in Phase III studies, and pending results, Bioniche expects to submit a biologics license application.

• Corgentech Inc., of South San Francisco, said data from a Phase II trial of 4975, its long-acting, non-opioid drug candidate, demonstrated that tendonitis patients treated with a single, local injection exhibited sustained, significant reductions at all pain endpoints and a significant improvement in function, compared to the placebo group at the four-week observation period. In a Phase II Morton's neuroma trial, patients who had failed conservative treatments who were injected with 100 micrograms of 4975 experienced greater pain relief compared to placebo as early as one week after the start of treatment. It was sustained at the four-week observation period (p<0.05). The data were presented at the 25th annual scientific meeting of the American Pain Society held in San Antonio.

• Ista Pharmaceuticals Inc., of Irvine, Calif., said data from a physician-sponsored clinical trial showed that patients treated with Xibrom achieved statistically significant improvements in both visual acuity and EDTRS letters gained, which were equivalent to Voltaren (diclofenac sodium) and Acular (ketorolac tromethamine) after three months of treatment. The data were presented at the 2006 Association for Research in Vision and Ophthalmology Annual Meeting in Fort Lauderdale, Fla. Xibrom is FDA approved to treat ocular inflammation and reduction of pain following cataract surgery.

• Neurobiological Technologies Inc., of Emeryville, Calif., initiated the first site outside the U.S. for its global Phase III acute ischemic stroke trials for Viprinex (Ancrod). The Ancrod Stroke Program I (ASP-1) and II (ASP-II) are trials of patients who will receive a brief intravenous infusion of Viprinex or placebo within six hours of stroke onset. Each trial will enroll 650 patients. The company expects that the trials will be conducted at up to 130 sites worldwide, and that 30 percent of the ASP-1 trials and 50 percent of the ASP-II trials will be conducted in sites outside the U.S.

• NicOx SA, of Sophia Antipolis, France, initiated a study designed to compare the 24-hour blood pressure profile of HCT 3012, a nitric oxide-donating derivative of naproxen, vs. naproxen, using ambulatory blood pressure monitoring. The study is expected to enroll about 120 volunteers with stable essential hypertension at 15 sites in the U.S. Results are expected in the fourth quarter. HCT 3012 is in Phase III development in osteoarthritis patients.

• Palatin Technologies Inc., of Cranbury, N.J., and King Pharmaceuticals Inc., of Bristol, Tenn., completed enrollment in two Phase IIb trials of bremelanotide in patients with erectile dysfunction. Bremelanotide is a melanocortin agonist in development for both male and female sexual dysfunction. The primary objective of the Phase IIb studies is to identify safe and efficacious doses for evaluation in Phase III pivotal trials slated to begin in the first quarter of 2007.

• Protalex Inc., of New Hope, Pa., successfully completed a Phase I trial of its lead compound, PRTX-100, in healthy volunteers to assess safety and tolerability. The company now expects a Phase II trial in idiopathic thrombocytopenic purpura to begin before the end of the year. PRTX-100 is a highly purified form of Staphylococcal Protein A designed to bind directly to monocytes and a subset of B cells to treat autoimmune diseases.

• Seattle Genetics Inc., of Bothell, Wash., said its ongoing Phase II trial of SGN-30 in cutaneous anaplastic large-cell lymphoma and other lymphoproliferative disorders showed that multiple patients achieved objective antitumor responses to the therapy, including both complete and partial responses. The trial includes patients with relapsed or refractory CD30-expressing cutaneous T-cell disease, including cutaneous ALCL, transformed mycosis fungoides and lymphomatoid papulosis. Data are being presented at the Society of Investigative Dermatology annual meeting in Philadelphia.

• Serono SA, of Geneva, said recruitment in the U.S. is beginning for the Phase III CLARITY (Cladribine Tablets in Treating MS Orally Study) trial in patients with relapsing forms of multiple sclerosis. The two-year study is expected to enroll more than 1,200 patients and assess clinical relapses, disability progression and MRI brain activity. Enrollment is on track to be completed in 2006.

• XenoPort Inc., of Santa Clara, Calif., said its Phase IIa trial of XP13512 for the treatment of post-herpetic neuralgia showed that, despite being administered at a lower molar daily dose, the drug produced a mean increase of 17 percent in the average plasma concentration of gabapentin compared to that produced by Neurontin in the same patient (p=0.005). The data were presented at the 25th annual scientific meeting of the American Pain Society in San Antonio. XP13512 is a transported prodrug of gabapentin, which has been sold by Pfizer Inc., of New York, as Neurontin since 1993, and is sold as a generic drug by a number of companies.

• XTL Biopharmaceuticals Ltd., of New York, started patient dosing in a Phase I trial of XTL-2125, an oral non-nucleoside hepatitis C virus polymerase inhibitor. The trial is a placebo-controlled, randomized, dose-escalating study, which will evaluate the safety, tolerability and antiviral activity of single and multiple doses of the drug. It will enroll 48 patients into six cohorts, with two placebo patients in each group. Each patient will receive a single dose, followed by a 14-day multidosing regimen commencing one week later.