Pro-Pharmaceuticals Updates Clinical Trials Progress
"We continue to make excellent progress in the clinic with DAVANAT(R), our lead product candidate," said David Platt, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "The outstanding results from our Phase I and Phase II trials of end-stage patients, who were refractory to chemotherapy, have led us to initiate three clinical trials with line one and line two patients. We believe we will improve the clinical benefit to patients over the current stand-of-care for colorectal and biliary cancer. We plan to begin dosing patients shortly.
“Management Discussion and Analysis of Financial Condition and Results of Operations”
"DAVANAT(R) is a complex carbohydrate drug that when given in combination with chemotherapeutic agents demonstrates reduced toxicity and increased efficacy by targeting the delivery and penetration of the chemotherapy to the tumor. The move to line l patients is recognition of the safety profile of DAVANAT(R)," Dr. Platt stated.
Clinical Trial Progress:
-- Phase I, line three/four, all Solid Tumors Trial and Phase II, line three/four, Colorectal Cancer Trial Results
Phase I and Phase II clinical trials of DAVANAT(R) with 5-FU data shows 1 patient with an objective partial tumor response and 20 patients stabilized out of 60. These patients had tumors, on average of 100mm, had a minimum of 12 weeks to live and were refractory to chemotherapy, including 5-FU. One patient from Phase II continues to be treated for 26 weeks. A Cholangiocarcinoma patient from our Phase I trial was treated for more than 56 weeks. The results of these studies compare very well and exceed results from similar recent studies in the same patient populations.
-- Phase II, line one, Colorectal Cancer Trial
U.S.-based Phase II, line one clinical trial of DAVANAT(R) with Avastin(R), 5-FU and leucovorin for patients with locally advanced and unresectable or metastatic colorectal cancer unable to tolerate intensive chemotherapy.
-- Phase III, line two, Colorectal Cancer Trial
Europe-based Phase III, line two clinical trial for patients with metastatic colorectal cancer is a multi-center, randomized with control groups study to evaluate the safety and efficacy of DAVANAT(R) in combination with 5-FU, leucovorin and irinotecan and/or oxaliplatin.
-- Phase II, line one, Biliary Cancer Trial
U.S.-based Phase II, line one clinical trial of DAVANAT(R) with 5-FU for patients with biliary cancer. Biliary cancer may represent an opportunity for orphan drug status approval.
DAVANAT(R), the Company's lead product candidate, is a proprietary polysaccharide polymer comprised of mannose and galactose carbohydrates in a CARBOSOME(TM) formation that enables the targeted delivery of chemotherapy drugs to protein receptors (lectins) on cancer cells.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience(R)
Pro-Pharmaceuticals is a development stage company engaged in the discovery, development and commercialization of nanotechnology carbohydrate-based therapeutic compounds for advanced treatment of cancer, liver, microbial, cardiovascular and inflammatory diseases, and viral infections. Initially, the product pipeline is principally focused on increasing the efficacy and decreasing the toxicity of approved chemotherapy drugs. The Company has been conducting clinical and pre-clinical studies with its lead product candidate, DAVANAT(R), in combination with 5-FU, leucovorin, irinotecan, doxorubicin, oxaliplatin, paclitaxel, cisplatin and bevacizumab (AVASTIN(R)). Results show that DAVANAT(R) exhibits a broad spectrum of activity with tested drugs. Founded in 2000, 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 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 and Advancing Drugs Through Glycoscience are registered trademarks of Pro-Pharmaceuticals. CARBOSOME is a trademark of Pro-Pharmaceuticals. AVASTIN is a trademark of Genentech, Inc.