Pro-Pharmaceuticals Announces Boston Medical Center Dosing Patients With DAVANAT(R) in Advanced Biliary Cancer Trial
Pro-Pharmaceuticals, Inc. (Amex:PRW), a company “Advancing Drugs Through Glycoscience®”, today announced that Boston Medical Center (BMC) began dosing patients in a Phase II clinical trial of DAVANAT® with 5-Fluorouracil (5-FU) to treat patients with advanced bile duct and gallbladder cancers.
“The addition of Boston Medical Center is an important achievement to our clinical development of DAVANAT® therapy for cancer patients,” said Eliezer Zomer, Ph.D., Executive Vice President, Product Development & Manufacturing, Pro-Pharmaceuticals, Inc. “The American Cancer Society estimates that about 9,250 new cases of bile duct and gall bladder cancers will be diagnosed this year in the United States and approximately 3,250 will die. Biliary tract and gall bladder cancers are challenging to treat, especially after failure of surgery which is the only effective curative therapy. There is no approved chemotherapy for biliary cancer and as such it offers potential orphan drug status for DAVANAT®.”
To date, eight patients have been dosed with DAVANAT® in combination with 5-FU in the advanced biliary trial. One patient has tumor shrinkage of greater than 30%, a partial response according to Response Evaluation Criteria in Solid Tumors (RECIST). Five patients are currently on study with stable disease for more than five months. Patients have experienced no increase in 5-FU-related toxicity.
About the Phase II Advanced Biliary Cancer Trial
The Simon two-stage designed, open label, multi-center study will evaluate the efficacy and safety of DAVANAT® in combination with 5-FU. The primary objectives of the trial are complete/partial tumor response (RECIST), stable disease and progression-free survival. A bile duct cancer patient from the Phase I trial remained on study for 13 months, far exceeding expectations. To date, 76 patients have been dosed with DAVANAT®/5-FU in Phase I/II clinical trials.
Clinical sites participating in this trial include the University of Michigan Comprehensive Cancer Center in Ann Arbor, Michigan; Barrett Cancer Center in Cincinnati, Ohio; Tampa General Hospital, Tampa, Florida; University of Leipzig in Leipzig, Germany, Sourasky Medical in Tel-Aviv, Israel, and The Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland. Additional information on this trial and the Company’s Phase II, first line, colorectal cancer clinical trial, can be found at www.clinicaltrials.gov website, key word: DAVANAT®.
About DAVANAT®
DAVANAT®’s mechanism of action is based upon binding to lectins on the surface of cancer cells. It is theorized that 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. This form of targeted delivery may allow for higher doses of chemotherapy administration with no increase in toxicity.
About Boston Medical Center
Boston Medical Center (BMC) is a private, not-for-profit, 575-licensed bed, academic medical center located in Boston’s historic South End. The hospital is the primary teaching affiliate for Boston University School of Medicine. Emphasizing community-based care, BMC, with its mission to provide consistently accessible health services to all, is the largest safety net hospital in New England. Additional information is available at www.bmc.org.
Pro-Pharmaceuticals, Inc. – Advancing Drugs Through Glycoscience®
Pro-Pharmaceuticals, Inc. is engaged in the discovery, development, and commercialization of therapeutic compounds for advanced treatment of cancer, liver, microbial, cardiovascular, and inflammatory diseases. The Company’s initial focus is the development of a new generation of anti-cancer treatments using polymers with the intent of enhancing the safety and efficacy of chemotherapy agents. The Company’s technology also is directed at “rescuing” drugs that were shelved for toxicity or “half-life” issues; increasing the solubility of existing drugs, and developing polymers as new chemical entities. The need to improve drug therapies, particularly anti-cancer agents, is significant and represents a large market opportunity. Founded in 2000, the Company is headquartered in Newton, Mass. Additional information is available at www.pro-pharmaceuticals.com. Additional information on the clinical trials and participating sites can be found at www.clinicaltrials.gov website, key word: DAVANAT®.
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. More information about those risks and uncertainties is contained in the Company’s most recent quarterly or annual report and in the Company’s 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. AVASTIN is a registered trademark of Genentech, Inc.