Dosing Begins in Phase II Davanat Trial

Pro-Pharmaceuticals announced that 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.

According to Pro-Pharmaceuticals, the open-label, multicenter study will evaluate the efficacy and safety of Davanat in combination with 5-FU.

The primary objectives of the trial are complete/partial tumor response, stable disease and progression-free survival, the company added.

According to the company, eight patients have been dosed in the advanced biliary trial, and one patient has experienced tumor shrinkage of more than 30 percent.

Five patients are currently on study with stable disease for more than five months. The company added that patients have experienced no increase in 5-FU-related toxicity.