Pro-Pharmaceuticals Files Phase II Clinical Trial Protocol for First Line Treatment of Colorectal Cancer Patients; Regimen Includes DAVANAT(R) with Avastin(R), 5-FU & Leucovorin.NEWTON, Mass. -- Pro-Pharmaceuticals (Amex: PRW "Parents are watching." See digispeak. ), a developer of novel nanotechnology carbohydrate compounds, today announced it has filed a clinical protocol with the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for an open-label, up to 50 patient, multi-center Phase II study of DAVANAT(R) with Avastin(R), 5-Fluorouracil (5-FU) and leucovorin as a first line treatment for locally advanced and unresectable or metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. in patients unable to tolerate intensive chemotherapy. "This trial is a strategic complement to our other clinical trials to assess the efficacy and safety of DAVANAT(R) when administered in combination therapies to treat cancer," said David Platt, Ph.D., President and Chief Executive Officer, Pro-Pharmaceuticals, Inc. "The purpose of this study is to determine if the addition of DAVANAT(R) to the current standard of care will improve patient outcomes." "In pre-clinical studies, we saw significantly improved anti-tumor activity when co-administering DAVANAT(R) with Avastin(R) and 5-FU as compared with Avastin(R) and 5-FU. Our Phase I results and preliminary Phase II results show that DAVANAT(R) is safe and well tolerated in patients. The goal of this study is to assess the clinical benefit by determining the percentage of patients exhibiting an objective response using Response Evaluation Criteria in Solid Tumors Response Evaluation Criteria In Solid Tumors (RECIST) - is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatments. (RECIST RECIST Response Evaluation Criteria in Solid Tumors (oncology review criteria) ) guidelines. "We continue to be encouraged by our DAVANAT(R) clinical program progress. We are finalizing the administrative processes, with multiple clinical sites, for our Phase II, line one Cholangiocarcinoma trial as well as our Phase III, line two colorectal cancer trial. In addition, we continue to dose patients and analyze data from our Phase II, line four colorectal cancer trial," Dr. Platt concluded. Phase II Cholangiocarcinoma Trial The Company initiated a U.S.-based Phase II study of its lead carbohydrate compound DAVANAT(R) with 5-FU for first line treatment of patients with Cholangiocarcinoma (cancer associated with the bile duct bile duct or biliary duct n. Any of the excretory ducts in the liver that convey bile between the liver and the intestine, including the hepatic, cystic, and common bile ducts. Also called gall duct. bile duct 1. ). The objectives of the trial are a complete or partial tumor response (RECIST) and progression-free survival. The multi-center, open-label study will evaluate approximately 30 patients treated with DAVANAT(R) and 5-FU for at least two cycles or to disease progression. Cholangiocarcinoma may represent an opportunity for orphan drug status approval. Phase III Colorectal Cancer Trial The Company initiated a Europe-based Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for second line treatment of patients with metastatic colorectal cancer. This study is a multi-center, double blind, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial of 120 patients to evaluate the safety and efficacy of DAVANAT(R) with 5-FU and leucovorin in combination with irinotecan or oxaliplatin. About DAVANAT(R) DAVANAT(R), the Company's lead product candidate, is a proprietary nanotechnology polysaccharide polysaccharide: see carbohydrate. polysaccharide Any of a large class of long-chain sugars composed of monosaccharides. Because the chains may be unbranched or branched and the monosaccharides may be of one, two, or occasionally more kinds, polymer comprised of mannose mannose /man·nose/ (man´os) a six-carbon sugar epimeric with glucose and occurring in oligosaccharides of many glycoproteins and glycolipids. man·nose n. and galactose carbohydrates in a CARBOSOME(TM) formation that enables the targeted delivery of chemotherapy drugs to protein receptors (lectins Lectins A class of proteins of nonimmune origin that bind carbohydrates reversibly and noncovalently without inducing any change in the carbohydrate. Lectins bind a variety of cells having cell-surface glycoproteins (carbohydrate bound proteins) or glycolipids ) 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 microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. , cardiovascular and inflammatory diseases. 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 nanotechnology product candidate, DAVANAT(R), in combination with 5-FU, leucovorin, irinotecan, doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased , oxaliplatin, paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); , cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. , 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 by competitors 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 registered trademark of Genentech, Inc. |
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