Pro-Pharmaceuticals Receives FDA Correspondence on Davanat NDA

Pro-Pharmaceuticals announced that the FDA has responded in a letter to the company's questions related to the submission of its new drug application (NDA) for Davanat.

Davanat is intended to be used as a functional excipient to be co-administered with 5-Fluorouracil (5-FU) in treating cancer patients. The FDA recommended that the company provide the chemistry, manufacturing and controls information necessary to support an NDA submission.

Davanat, the company's lead drug candidate, is a carbohydrate polymer composed of mannose and galactose (galactomannan). Davanat is a target delivery technology that may enhance the safety and efficacy profile of a variety of FDA-approved drugs. 5-FU, a chemotherapy drug, is used to treat various types of cancers, including colorectal, breast and gastrointestinal cancers.

The company believes that Davanat's mechanism of action is based on binding to lectins on the surface of cancer cells. It is theorized that Davanat targets specific lectin receptors that are over-expressed on cancer cells. This form of targeted delivery may allow for higher doses of chemotherapy administration with no increase in toxicity, according to the company.