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Pro-Pharmaceuticals Begins Patient Dosing for Biliary Cancer Trial

Posted on: Friday, 27 July 2007, 09:05 CDT

Pro-Pharmaceuticals says Boston Medical Center has begun dosing patients in a Phase II clinical trial of Davanat to treat patients with advanced bile duct and gallbladder cancers.

Eliezer Zomer, executive vice president, product development & manufacturing, Pro-Pharmaceuticals, explained: "Biliary tract and gall bladder cancers are challenging to treat, especially after failure of surgery which is the only effective curative therapy. There is no approved chemotherapy for biliary cancer and as such it offers potential orphan drug status for Davanat."

To date, eight patients have been dosed with the drug in combination with 5-FU in the advanced biliary trial. One patient has tumor shrinkage of greater than 30%, 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.

The two-stage designed, open label, multi-center study will evaluate the efficacy and safety of the drug in combination with 5-FU. The primary objectives of the trial are complete/partial tumor response, stable disease and progression-free survival. To date, 76 patients have been dosed with Davantat/5-FU in Phase I/II clinical trials.

Source: Datamonitor

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