• Antares Pharma. of Ewing, N.J., said a special protocol assessment has been completed with the FDA for the pivotal efficacy trial of Anturol for the treatment of overactive bladder. The randomized, double-blind, open-label, parallel, placebo-controlled, multicenter trial will evaluate efficacy when administered topically once daily for 12 weeks, predominantly in patients with urge incontinency episodes. The trial is expected to enroll up to 600 patients (200 per arm) using two dose strengths of Anturol vs. a placebo. The primary endpoint will be efficacy against the placebo defined as the number of urinary incontinence episodes experienced. Secondary end points include changes from baseline in urinary urgency, average daily urinary frequency, patient perceptions as well as safety and tolerability including skin irritation.

• Athersys Inc., of Cleveland, initiated a Phase I trial in the UK for ATHX-105, an oral drug that has been shown to selectively inhibit the 5HT2c receptor agonist without activating 5HT2b, a related receptor, to treat obesity without causing cardiovascular side effects. The trial will involve 60 to 80 overweight, healthy subjects with a body mass index of 25 to 35 and is expected to be completed in the first quarter of 2008.

• ImmunoMod LLC, of Charleston, S.C., received an FDA Orphan Drug Grant award for a Type I diabetes therapeutic and is beginning its first clinical trials at the Children's Hospital of Philadelphia. A 2006 spinout of the Medical University of South Carolina, ImmunoMod has identified as its preliminary focus the prevention of the onset of Type I diabetes by protecting beta cell function in early stage diabetic youth.

• InterMune Inc., of Brisbane, Calif., earned a $10 million development milestone when its partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, reported it had submitted an amended clinical trial authorization in Europe, the final step before initiating a Phase Ib study of hepatitis C virus protease inhibitor ITMN-191 in chronic hepatitis C patients. The amendment takes into consideration new competitor information, preclinical and in vitro data on ITMN-191 and pharmacokinetic observations from a Phase Ia study which was completed in May. Shares of InterMune lost 7.8 percent July 24 on an analyst report that ITMN-191 faced possible delays in the trial. Shares of InterMune (NASDAQ:ITMN) gained 49 cents Wednesday to close at $23.55.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said Boston Medical Center began dosing patients in a Phase II clinical trial of Davanat with 5-Fluorouracil (5-FU) to treat patients with advanced bile duct and gallbladder cancers. Eight patients have been dosed with Davanat in combination with 5-FU in the advanced biliary trial. One patient has tumor shrinkage of greater than 30 percent, a partial response, according to Response Evaluation Criteria in Solid Tumors. Five patients are currently on study with stable disease for more than five months. Patients have experienced no increase in 5-FU-related toxicity.