PRO-PHARMA SUBMITS APPLICATION FOR DAVANAT WITH 5-FU

Pro-Pharmaceuticals announced it has begun the process of submitting a new drug application to the FDA for co-administration of Davanat with 5-Fluorouracil (5-FU) for treatment in cancer patients.

"Our goal is to get our lead compound, Davanat, to market," David Platt, president and CEO of the company, said. "Based on recent data analysis from our Phase I and Phase II clinical trials, we believe Davanat has the potential to improve the pharmacokinetic profile of 5-FU, as well as other FDA-approved anticancer drugs, without increasing toxicity markers as would be expected with increased 5-FU exposure."

The Phase I trial data indicates that 5-FU, in combination with Davanat, remained longer in the bloodstream (up to 10 times) without increasing in toxicity. Increased exposure to 5-FU may explain why 54 percent of the end-stage cancer patients, who had measurable disease, were stabilized from two to 13 months, and 70 percent were stabilized at the highest Davanat dose level. In the Phase II trial, patients had no increase in toxicity with increased exposure to 5-FU in the presence of Davanat.

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. 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 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, according to the company.