Pro-Pharmaceuticals seeks OK for phase 2 colorectal cancer trial

By Elaine Rigoli

Tampa, Fla., July 25 - Pro-Pharmaceuticals has filed a clinical protocol with the Food and Drug Administration for an open-label, multi-center phase 2 study of Davanat with Avastin, 5-Fluorouracil (5-FU) and leucovorin as a first-line treatment for locally advanced and unresectable or metastatic colorectal cancer in patients unable to tolerate intensive chemotherapy.

The company said it started a U.S.-based phase 2 study of Davanat with 5-FU for first-line treatment of patients with cancer associated with the bile duct. The objectives of the trial are a complete or partial tumor response (Recist) and progression-free survival.

This multi-center, open-label study will evaluate about 30 patients treated with Davanat and 5-FU for at least two cycles or to disease progression.

The company also said it started a European phase 3 clinical trial for second-line treatment of patients with metastatic colorectal cancer.

Pro-Pharmaceuticals develops nanotechnology carbohydrate compounds and has headquarters in Newton, Mass.

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