Pro-Pharmaceuticals' DAVANAT Prevents Mucositis, a Serious Side Effect of Chemotherapy, in All 100 Cancer Patients Treated
NEWTON, Mass.--(BUSINESS WIRE)--Apr 15, 2009 - Pro-Pharmaceuticals, Inc. (OTCBB: PRWP.OB), today announced that a review of data from its Phase I & II clinical trials show that no mucositis serious adverse events (SAEs) were found in approximately 100 cancer patients that were treated with DAVANAT® and chemotherapy that included 5-FU. For most cancer treatment, about 5-15% of patients get mucositis. However, with 5-FU up to 40% get mucositis, and 10-15% get grade 3-4 oral mucositis. Even in patients with more than 100 cycles of treatments with DAVANAT® and 5-FU, none experienced gastrointestinal (GI) SAEs. SAEs of grade levels 3, 4, 5 result in life threatening events, in-patient hospitalization, persistent or significant disability, or death. 5-FU is one of the most widely used chemotherapy drugs in the world and is used to treat various types of cancers, including colorectal, breast and gastrointestinal.
Mucositis is a significant side effect in chemotherapy, depending on the type of cancer and treatment. It is characterized by intestinal tissue destruction throughout the GI tract, including painful mouth ulcerations and severe gastrointestinal symptoms interfering with nutrition and treatment. There are currently no effective treatments for GI mucositis. Only a narrow group of patients are eligible for treatment of oral mucositis and it is expensive. Patients suffering from debilitating mouth sores may require high doses of narcotics, such as morphine, and intravenous feeding to receive nutrition and maintain hydration. According to the American Cancer Society, in the U.S. alone, there are more than 1.5 million new cancer cases each year.
“Our goal is to improve the clinical benefit for patients by extending their survival, improving their quality of life and reducing the rising costs of health care. The data from the cancer patients in our clinical trials indicates DAVANAT® improves efficacy and reduces the side effects associated with chemotherapy regimens,” said Theodore Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals, Inc. “We are developing a new generation of anti-cancer treatments using carbohydrate polymers that are aimed at increasing survival and improving the quality of life for cancer patients. Our lead product candidate, DAVANAT®, is a patented new chemical entity that we believe, when administered in combination with chemotherapy, increases the efficacy while reducing adverse side effects of chemotherapy.”
DAVANAT®, the Company's lead product candidate, is a carbohydrate polymer composed of mannose and galactose. DAVANAT®'s mechanism of action is based on interacting with lectins on the cell surface. DAVANAT® targets specific lectin receptors (galectins) that are over-expressed 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 is engaged in the discovery, development and commercialization of carbohydrate therapeutics for advanced treatment of cancer and fibrosis. Initially, the product pipeline is focused on increasing the efficacy and decreasing the toxicity of chemotherapy drugs which results in improved quality of life. 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 as a result of various factors including, but not limited to, the following: uncertainties as to the utility and market for our potential products; uncertainties associated with pre-clinical and clinical trials of our product candidates; our limited experience in product development and expected dependence on potential licensees and collaborators for commercial manufacturing, sales, distribution and marketing of our potential products; possible development by competitors of competing products and technologies; lack of assurance regarding patent and other protection of our proprietary technology; compliance with and change of government regulation of our activities, facilities and personnel; uncertainties as to the extent of reimbursement for our potential products by government and private health insurers; our dependence on key personnel; our history of operating losses and accumulated deficit; and economic conditions related to the biotechnology and biopharmaceutical industry. We cannot assure you that we have identified all the factors that create uncertainties. Readers should not place undue reliance on forward-looking statements.
More information about those risks and uncertainties is contained and discussed in the "Management Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" sections of 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.
Contact: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
Posted: April 2009