NEWTON, Mass. - (Business Wire)
Pro-Pharmaceuticals, Inc. (AMEX: PRW), a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds in the treatment of cancer, today announced it has submitted clinical and pre-clinical data to the U.S. Food and Drug Administration (
“FDA
”) for a pre-Investigational New Drug (IND) meeting that is scheduled for October 8
th. The Company plans to present the development plan to the FDA for an anti-hypoxia drug to be used in combination with DAVANAT
® and 5-FU to treat advanced solid tumors, including head and neck, breast and colorectal cancers. The plan is in direct response to current studies indicating tumors resistance to chemotherapy and radiation are linked to hypoxia.
Hypoxia is a condition in which there is a decrease in the oxygen supply to a tissue. Many tumors contain a significant fraction of hypoxic cells, due to insufficient vascularization. The reduction in oxygen within tumors confers resistance to both radiotherapy and chemotherapy, and in many cases correlates with a poor prognosis.
“Results of end-stage colorectal cancer patients from our completed Phase II trial showed DAVANAT®, administered in combination with 5-FU, extended median survival to 6.7 months compared with 4.6 months for the Best Standard of Care,” said Eliezer Zomer, Ph.D., Executive Vice President, Product Development & Manufacturing, Pro-Pharmaceuticals. “This unique combination of drugs offers end stage cancer patients a viable option while improving their quality of life and reducing side effects. This patient population represents a significant market opportunity.”
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. – 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 therapeutic compounds 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 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, Inc.
Anthony D. Squeglia, CFO, 617-559-0033
squeglia@pro-pharmaceuticals.com
or
The Investor Relations Group, 212-825-3210
Investor Relations
Conrad F. Mir
conrad@investorrelationsgroup.com
or
Christine A. Berni
christine@investorrelationsgroup.com
or
Media Relations
Laura Colontrelle
lcolontrelle@investorrelationsgroup.com
