FDA Grants IND for Pro-Pharmaceuticals' DAVANAT to Treat Breast Cancer Patient
Pro-Pharmaceuticals, Inc. 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.
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.
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.
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