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Pro-Pharmaceuticals to Present New DAVANAT(R) Data at the International Society of Oncodevelopmental Biology and Medicine Conference

Posted on: Tuesday, 20 September 2005, 06:00 CDT

Pro-Pharmaceuticals, a developer of novel carbohydrate compounds that enable the targeted delivery of chemotherapy drugs to cancer cells, today announced Eliezer Zomer, Ph.D., Executive Vice President, Product Development and Manufacturing will present, "Targeting Lectins, a Clinical Trial of Galactomannan Co-Administered with 5-Fluorouracil (5-FU), in Patients with Refractory Solid Tumors, Pre-Clinical and Phase l Results," at the International Society of Oncodevelopmental Biology and Medicine (ISOBM) Conference to be held in Rhodes, Greece, September 24-28, 2005.

"The new data indicates DAVANAT(R) exhibits broad spectrum enhancement of anti-tumor drugs. Data from the recently finished Phase I trial that evaluated advanced patients with a median tumor load of more than 100mm indicates the potential benefit of DAVANAT(R) in 5-FU refractory patients," said Eliezer Zomer, Ph.D. "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 trials for colorectal cancer and cholangiocarcinoma."

ISOBM Conference

The International Society of Oncodevelopmental Biology and Medicine (ISOBM) is a leading society for scientists, clinicians and company members developing and validating assays for tumor diagnostics and management of cancer therapy. The scientific program will present new discoveries in the research of tumor cell biology (carcinogenesis, oncogenes and tumor suppressor genes, metastasis formation/invasion, angiogenesis) as well as clinical applications of tumor markers - established and new ones - for tumor diagnostics and therapy guiding for various cancers (breast, ovary, prostate, colon, melanoma, others).

Phase l Clinical Trial

The Phase l multi-center, open-label trial was designed for cancer patients with advanced solid tumors that were not amenable to surgery, radiation, or chemotherapy, were refractory to 5-FU, and had a minimum of 12 weeks to live. The objectives of the study were to determine the Maximum Tolerated Dose and Dose Limiting Toxicity of DAVANAT(R) as a single agent, and when administered in combination with 5-FU; to determine the pharmacokinetic profile of 5-FU in the presence of DAVANAT(R); and, to determine the effect of DAVANAT(R) /5-FU on tumor size in patients with measurable disease. The Phase l study was completed in March. Additional information is available at www.asco.org (search word: DAVANAT).

Phase II Cholangiocarcinoma Trial

The Company recently submitted a clinical protocol 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 U.S. Food & Drug Administration (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 l trial. The patient has been treated for 10 months and continues to respond well.

Phase II Colorectal Cancer Trial

The Company has an ongoing Phase II clinical trial of DAVANAT(R)/5-FU in refractory colorectal cancer patients. Recruiting and treatment of patients is currently ongoing at three clinical sites. Additional information is available at www.clinicaltrials.gov.

About DAVANAT(R)

DAVANAT(R) is a proprietary polysaccharide in a CARBOSOME(TM) formation that target delivers chemotherapy drugs to protein receptors (lectins) that are specific to 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 pre-clinical studies for 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 chemotherapeutic agents. 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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