FDA grants IND for Davanat to treat breast cancer patient

Pro-Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky. Davanat also is being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.

The American Cancer Society estimates that approximately 180,000 new cases of breast cancer will be diagnosed in the United States this year and approximately 45,000 deaths will occur.

Pre-clinical studies showed that Davanat, in combination with chemotherapy, significantly reduced tumor growth in mice implanted with metastatic human breast cancer. Results from similar pre-clinical studies designed to optimize formulations of Davanat and 5-FU also lowered toxicity as indicated by the weight gain of the mice in the study.

"Our goal is to extend survival and improve the quality of life for cancer patients," said Eliezer Zomer, Ph.D., Executive Vice President Product Development & Manufacturing, Pro-Pharmaceuticals. "As recently reported, data from a Phase II trial for end-stage colorectal cancer patients showed Davanat extended median survival to 7 months with significantly reduced levels of side effects. Additionally, the data showed no apparent change from the baseline measurements in clinical blood test parameters including platelets and white blood cell counts. Reduced toxicity data indicates improved quality of life."

The Company recently completed an important step toward submission of a New Drug Application (NDA) by submitting a Drug Master File (DMF) with the FDA. The DMF contains information that will be used to support an NDA filing.

Davanat is a proprietary carbohydrate drug that is administered with chemotherapies and biologics to treat cancer. Davanat's mechanism of action is based on binding to lectins. Davanat targets specific lectin receptors (Galectins) 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.