FDA Grants IND For Pro-Pharmaceuticals' DAVANAT® To Treat Breast Cancer Patient

Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 30 Aug 2008 - 2:00 PDT

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Pro-Pharmaceuticals, Inc. (Amex: PRW), today 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.

About DAVANAT®

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.

Pro-Pharmaceuticals, Inc.

Pro-Pharmaceuticals is engaged in the discovery, development and commercialization of first-in-class, targeted therapeutic compounds for advanced treatment of cancer, liver, microbial and inflammatory diseases. The initial focus is the development of a new generation of anti-cancer treatments using carbohydrate compounds to increase survival and improve the quality of life for cancer patients. DAVANAT®, the lead pipeline candidate, is a proprietary new chemical entity that is currently in Phase II trials for first-line treatment of colorectal and biliary cancer. The Company's technology also is being tested to treat diseases such as liver and kidney fibrosis. The Company is headquartered in Newton, Mass. Additional information is available at www.pro-pharmaceuticals.com.

FORWARD LOOKING STATEMENTS: Any statements in this news release about future expectations, plans and prospects for the Company, including without limitation statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements as defined in the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in such statements. We caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking statements. More information about those risks and uncertainties is contained the Company's most recent quarterly or annual report and in the Company's other reports filed with the Securities and Exchange Commission. The forward-looking statements represent the Company's views as of the date of this news release and should not be relied upon to represent the Company's views as of a subsequent date. While the Company anticipates that subsequent events may cause the Company's views to change, the Company disclaims any obligation to update such forward-looking statements. DAVANAT is a registered trademark of Pro-Pharmaceuticals.