Pro-Pharmaceuticals Submits Data For Registration Of DAVANAT(R) To Treat Late-Stage Colorectal Cancer Patients

Main Category: Colorectal Cancer
Also Included In: GastroIntestinal / Gastroenterology;  Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 17 Sep 2008 - 4:00 PDT

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Pro-Pharmaceuticals, Inc. (AMEX: PRW), a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds to treat cancer, has submitted supporting clinical and manufacturing data to the U.S. Food and Drug Administration (FDA) for a New Drug Application (NDA) registration of DAVANAT®, a new chemical entity, for the treatment of advanced colorectal cancer. The Company has requested a meeting with the FDA to review the PK study needed to complete the request for the NDA.

"Our goal is to commercialize DAVANAT® and to generate revenue in 2009," said Theodore Zucconi, Ph.D., President, Pro-Pharmaceuticals, Inc. "In pre-clinical and clinical studies, DAVANAT® has improved efficacy and reduced toxicity of chemotherapies and biologics, such as 5-FU, Irinotecan, Oxaliplatin, Cisplatin, Avastin®, Taxol and Doxorubicin. We have regional agreements in place to market DAVANAT® internationally. The need to improve drug therapies, particularly anti-cancer agents for late-stage cancer patients is significant and represents a large market opportunity"

The Company recently submitted a Drug Master File (DMF) for DAVANAT® with the FDA. The DMF can be cross-referenced by potential pharmaceutical partners to use in combination with other therapies to expedite clinical studies and submission of NDAs. The DMF provides confidential detailed information about facilities, processes and validated analytical methods used in the manufacturing, processing, packaging, and stability of drugs. The information contained in the DMF is being used to support the NDA filing and the planned Investigational New Drug application for DAVANAT® and an anti-hypoxia drug to treat cancer.

As previously reported, data from a completed clinical trial for end-stage colorectal cancer patients showed DAVANAT®, in combination with 5-FU, significantly extended median survival to 6.7 months compared with 4.6 months for the Best Standard of Care. Additionally, the data showed considerably reduced side effects, 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.

About DAVANAT®

DAVANAT®, a new chemical entity, is a proprietary carbohydrate compound 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. - Advancing Drugs Through Glycoscience®

Pro-Pharmaceuticals is engaged in the discovery, development, and commercialization of carbohydrate-based, targeted therapeutics for advanced treatment of cancer, liver, microbial, and inflammatory diseases. Initially, the product pipeline is focused on developing targeted therapeutics to treat cancer. The Company's technology also is being developed to explore the treatment of liver and kidney fibrosis. The Company is headquartered in Newton, Mass. Additional information is available at http://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 in the Company's most recent quarterly or annual report and other reports filed with the Securities and Exchange Commission. 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 and Advancing Drugs Through Glycoscience are registered trademarks of Pro-Pharmaceuticals.

Pro-Pharmaceuticals