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 study will evaluate up to patients treated with Davanat and 5-Fluorouracil (5-FU) for at least two cycles or to disease progression. Pro-Pharmaceuticals believes treatment of biliary cancer may represent an opportunity for orphan drug status approval.
The company has said that Davanat's mechanism of action is based upon binding to lectins on the surface of cancer cells. It is believed that Davant 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.