PRO-PHARMACEUTICALS BEGINS TRIAL OF COLORECTAL CANCER TREATMENT
Pro-Pharmaceuticals announced it has filed a clinical protocol with the FDA for an open-label, multicenter Phase II 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 also initiated a Phase II study of Davanat with 5-FU for first-line treatment of patients with cholangiocarcinoma (cancer associated with the bile duct). The objectives of the trial are a complete or partial tumor response and progression-free survival. The multicenter, open-label study will evaluate approximately 30 patients for at least two cycles or to disease progression. The cholangiocarcinoma indication may represent an opportunity for orphan drug status.
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