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Pro-Pharmaceuticals Receives Clearance From EMEA to Initiate International Phase III Colorectal Cancer Clinical Trial

Posted on: Monday, 7 November 2005, 09:00 CST

Pro-Pharmaceuticals, a developer of novel carbohydrate compounds that enable the targeted delivery of chemotherapy drugs to cancer cells, today announced it has received clearance from the European Medicines Agency (EMEA) to initiate a European Phase III clinical trial for second line treatment of patients with metastatic colorectal cancer. The Company has contracted with a clinical research organization (CRO) that is currently working with investigators and investigational review boards (IRB) in France and Germany. 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 Company expects to begin patient enrollment for this trial in the first quarter of 2006.

This Phase III study is an international, multi-center, randomized clinical trial to evaluate the safety and efficacy of DAVANAT(R) with 5-Fluorouracil (5-FU) in combination with Irinotecan or Oxaliplatin for second line treatment of patients with metastatic colorectal cancer. The primary endpoint is progression free survival. Secondary endpoints are response rate, time to progression, and quality of life.

"We continue to be encouraged by our DAVANAT(R) clinical program progress," said David Platt, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "We continue to ramp up our Phase II colorectal and cholangiocarcinoma (bile duct) clinical trials. We are dosing patients in our Phase II colorectal cancer trial at three clinical sites and are actively recruiting additional clinical sites for our Phase II and Phase III trials. We are encouraged with the anti-tumor activity of DAVANAT(R) /5-FU and look forward to confirming the benefit of this combination therapy in Phase II/III trials for colorectal cancer and cholangiocarcinoma."

About the European Medicines Agency

The EMEA's main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonization.

Phase II Colorectal Cancer Trial

The Company has an ongoing Phase II clinical trial of DAVANAT(R)/5-FU in colorectal cancer patients that are refractory to 5-FU. To date, 10 patients have been dosed at three clinical sites. Additional information is available at www.clinicaltrials.gov.

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 its lead carbohydrate compound DAVANAT(R) with chemotherapeutic agent 5-FU for first line treatment of patients with cholangiocarcinoma (cancer of the bile duct). In May of this year, the FDA approved an application for a "compassionate use" Investigational New Drug to continue treating a patient for cholangiocarcinoma with liver metastases who participated in the Company's Phase I trial. The patient has been treated for 12 months and continues to respond well. The Company expects to begin patient enrollment in the first quarter of 2006.

About DAVANAT(R)

DAVANAT(R) 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 drug development company commercializing a new generation of anti-cancer treatments using carbohydrate compounds to Glyco-Upgrade(TM) the safety and efficacy of FDA-approved chemotherapy drugs by target delivering the drug to cancer cells. The Company has been conducting clinical trials with 5-fluorouracil, as well as pre-clinical studies with irinotecan, doxorubicin, oxaliplatin, paclitaxel, cisplatin, and bevacizumab both in combination with DAVANAT(R) as well as other polysaccharide compounds. Human colon and breast xenography are being used to optimize formulations and 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. Glyco-Upgrade and CARBOSOME are trademarks of Pro-Pharmaceuticals.

Source: Business Wire

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