PRO-PHARMA BEGINS DOSING IN BILIARY CANCER CLINICAL TRIAL

Pro-Pharmaceuticals has begun dosing patients in its Phase II, first-line biliary cancer trial. The trial is an open-label, multicenter study of Davanat with 5-Fluorouracil (5-FU) to treat patients with advanced bile duct and gall bladder cancer.

The primary objectives of the trial are a partial or complete tumor response and stable disease. Secondary outcomes include progression-free survival and quality of life. The multicenter, open-label study will evaluate up to 42 patients treated with Davanat and 5-FU for at least two cycles or to disease progression. Treatment of biliary cancer may represent an opportunity for orphan drug status approval.

Davanat is a carbohydrate (polysaccharide) polymer composed of mannose and galactose. The company believes Davanat's mechanism of action is based on binding to lectins on the cell surface. Lectins are carbohydrate-binding proteins found in increased amounts on cell surfaces. Davanat, when injected into humans, recognizes and attaches to lectins. It is theorized that the drug targets specific lectin receptors (Galectins) that are over-expressed on cancer cells. Current research indicates that Galectins affect cell development and play important roles in cancer, including tumor-cell survival, angiogenesis and tumor metastasis. This form of targeted delivery may allow for higher doses of chemotherapy administration with no increase in toxicity.