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Pro-Pharmaceuticals Presents Phase II/III Clinical Trials at the Central European Society for Anti-Cancer Drug Research Conference

24 Feb 2006

NEWTON, MA, USA | Feb 24, 2006 | Pro-Pharmaceuticals, Inc. (Amex: PRW), a developer of novel carbohydrate-based therapeutic

compounds, today announced that Hana Chen-Walden, M.D. is presenting an update of the Company's Phase II and Phase III clinical trials at the Central European Society for Anti-Cancer Drug (CESAR) Conference being held today in Frankfurt, Germany. Dr. Chen-Walden provides the Company with management of clinical and regulatory activities in Europe.

Phase III Colorectal Cancer Trial

The Company received clearance from the European Medicines Agency in November 2005 to initiate a European Phase III clinical trial for second line treatment of patients with metastatic colorectal cancer. The full trial is expected to have up to 800 patients in 60 centers and consist of four arms: Irinotecan, leucovorin and 5-FU (FOLFIRI) with and without DAVANAT(R), and oxaliplatin, leucovorin and 5-FU (FOLFOX) with and without DAVANAT(R). The Company plans to report interim results after 120 patients have been treated. 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. The primary endpoint is progression free survival. Secondary endpoints are response rate, time to progression, and quality of life. The Company expects to begin patient enrollment in the second quarter

Phase II Cholangiocarcinoma Trial

The Company submitted a clinical protocol to the U.S. Food & Drug Administration (FDA) in September 2005 for a Phase II open label, multi-center study of its lead carbohydrate compound DAVANAT(R) with chemotherapeutic agent 5-FU for first line treatment of patients with cholangiocarcinoma (cancer of the bile duct). The Company plans to expand this trial to Europe and is expected to treat up to 30 patients. The primary endpoints of the study are to document a complete or partial response, rate of stable disease, safety, and progression-free survival. The Company expects to begin patient enrollment in the second quarter.

The FDA approved an application for a "compassionate use" Investigational New Drug (IND) in May 2005 to continue treating a patient for cholangiocarcinoma with liver metastases who participated in the Company's Phase I trial. The patient had been treated for 13 months. In January of this year, the FDA allowed a "compassionate use" IND to treat another patient.

Ongoing Phase II Colorectal Cancer Trial

The Company has an ongoing Phase II clinical trial of DAVANAT(R)/5-FU for third and fourth line treatment of colorectal cancer patients in the U.S. that are refractory to chemotherapy, including 5-FU. To date, 15 patients have been dosed at three clinical sites. Additional information is available at www.clinicaltrials.gov.

Central European Society for Anti-Cancer Drug Research

The Central European Society for Anti-Cancer Drug Research (CESAR) is a European Non-Profit Organization aiming to foster research and development of novel anti-tumor agents, therapies and therapeutic strategies in oncology, fostering translation of basic research into clinical application via integral drug development. The CESAR comprises scientists from basic research, and preclinical and clinical oncology in Austria, Germany and Switzerland.

About DAVANAT(R)

DAVANAT(R) is a proprietary polysaccharide polymer comprised of mannose and galactose carbohydrates in a CARBOSOME(TM) formation that enables the target delivery of chemotherapy drugs to protein receptors (lectins) on cancer cells.

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

Pro-Pharmaceuticals is developing novel carbohydrate-based therapeutic compounds. 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 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: Pro-Pharmaceuticals, Inc

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