Topic: Phase II trial of Davanat
This is a drug company press release
From July 25, 2006
Phase II Cholangiocarcinoma Trial
The Company initiated a U.S.-based Phase II study of its lead carbohydrate compound DAVANAT(R) 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 (RECIST) and progression-free survival. The multi-center, open-label study will evaluate approximately 30 patients treated with DAVANAT(R) and 5-FU for at least two cycles or to disease progression. Cholangiocarcinoma may represent an opportunity for orphan drug status approval.