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Pro-Pharmaceuticals Announces Two International Clinical Sites in Colorectal Cancer Trial of DAVANAT(R)/5-FU

Posted on: Tuesday, 13 December 2005, 09:00 CST

Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of novel carbohydrate compounds that enable the targeted delivery of drugs, today announced the addition of two clinical sites in Israel: Shaare Zedek Medical Center in Jerusalem and Soroka Medical Center in Beer Sheva of its Phase II colorectal cancer trial with DAVANAT(R)/5-FU. Patients are now being recruited at six clinical sites, including four in the United States: Medical Oncology and Hematology, Waterbury, CT; Hematology-Oncology Associates of the Treasure Coast, Port St. Lucie, FL; Ochsner Clinic, New Orleans, LA, and University of Michigan Comprehensive Cancer Center, Ann Arbor, MI. DAVANAT(R) is a proprietary polysaccharide in a CARBOSOME(TM) formation that target delivers chemotherapy drugs to protein receptors (lectins) on cancer cells.

In this Phase II trial using Simon's two-stage design, the Company expects to enroll up to 15 patients in Stage I and up to 18 patients in Stage 2. Patients with metastatic colorectal cancer, which has spread despite treatment with approved therapies, are receiving DAVANAT(R)/5-FU in monthly cycles for at least two cycles, or until their disease progresses. These patients are refractory to 5-FU and have a minimum of 12 weeks to live. Dosing of patients began in May 2005. Additional information is available at www.clinicaltrials.gov.

Shaare Zedek Medical Center, located in Jerusalem, is a 500-bed hospital with 350 physicians and more than 700 nurses treating more than 45,000 patients in 2004. Founded in 1902, Shaare Zedek is renowned for its medical treatment combined with special care. Soroka Medical Center, located in Beer Sheva in the Negev, is Israel's fastest growing region. Soroka Medical Center is a 1,000-bed hospital with 600 physicians and more than 1,200 nurses that handle 90,000 hospitalizations and 22,000 operations in one year. Soroka Medical Center is known for its excellent level of care.

Phase II Cholangiocarcinoma Trial

The Company submitted a clinical protocol to the U.S. Food & Drug Administration (FDA) in September for a Phase II study of our lead carbohydrate compound DAVANAT(R) with 5-FU for first line treatment of patients with cholangiocarcinoma. In May of this year, the FDA approved an application for a "compassionate use" Investigational New Drug (IND) to continue treating a patient with cholangiocarcinoma who participated in our Phase I trial. This patient has been treated for 13 months and continues to respond well.

Phase III Colorectal Cancer Trial

The Company received clearance from the European Medicines Agency (EMEA) to initiate a European-based Phase III clinical trial for second line treatment of patients with metastatic colorectal cancer who failed combination therapies that included irinotecan or oxaliplatin. The trial will be conducted at clinical sites in the European Union (EU) and countries outside of the EU following regulatory and ethics approval in each country.

About DAVANAT(R)

DAVANAT(R) is a target delivery technology within a new paradigm that may enhance the safety and efficacy profile of a variety of FDA-approved drugs. DAVANAT(R) is a proprietary carbohydrate (polysaccharide) polymer comprised of mannose and galactose in a CARBOSOME(TM) formation that enables the target delivery of chemotherapy drugs to protein receptors (lectins) on cancer cell. By combining proprietary, novel carbohydrates designed to bind to these lectins with currently marketed chemotherapeutics, we seek to target deliver these anti-cancer agents more specifically to cancer cells, thereby reducing their concentration in healthy tissue and the toxicities associated with their administration.

Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience(R)

Pro-Pharmaceuticals is developing proprietary carbohydrate-based compounds to enable the targeted delivery of drugs. Initially, the product pipeline is principally focused on increasing the efficacy and decreasing the toxicity of approved chemotherapy drugs. The Company has been conducting pre-clinical and clinical studies 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. 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. Because of uncertainties and risks facing the Company, many of which are outside of the Company's control, future events could cause actual results to differ materially from those indicated by such 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 herein 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 registered trademark of Genentech, Inc.

Source: Business Wire

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