FDA Clears CoFactor to Begin Second Stage of Phase II Clinical Trial for Metastatic Colorectal Cancer.SAN DIEGO -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX ANX Annex ANX Adventrx Pharmaceuticals (San Diego, CA) ANX Automotive Network Exchange (AIAG) ANX Advanced Network Exchange ANX Ascending Node Crossing (satellites) ) today announced that it has been granted allowance by the Food and 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. ) to begin recruiting patients for the second stage of its Phase II trial using CoFactor cofactor An atom, organic molecule, or molecular group that is necessary for the catalytic activity (see catalysis) of many enzymes. A cofactor may be tightly bound to the protein portion of an enzyme and thus be an integral part of its functional structure, or it may (TM) to modulate the effect of 5-fluorouracil (5-FU) for metastatic colorectal cancer. The Company reported available clinical data to the FDA related to the 23 initial patients recruited as part of the Simon Two-Stage trial design. Based on this submission, the FDA granted the Company authorization to proceed to the second stage of the study and enroll an additional 25 patients. The Phase II trial of CoFactor is an open-label single arm study to evaluate safety, tumor response, time-to-tumor-progression and overall survival in patients treated with CoFactor and 5-FU. Eligible patients for this study have surgically incurable, metastatic colon or rectal adenocarcinoma, and no prior chemotherapy for metastatic disease. "We are extremely pleased to receive the go-ahead from the FDA to advance CoFactor to the second stage of the Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II ," said Cellia Habita, M.D., Ph.D., Vice President of Clinical and Medical Affairs for ADVENTRX. "At this rate, we currently anticipate completing total patient enrollment by the end of 2004 and reporting results in the spring." The Company currently plans to file in 2004 in the European Union and in 2005 in the US for clearance to begin 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. controlled Phase II multicenter metastatic colorectal cancer trials. In addition, the Company currently intends to file with the FDA and the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) in the first quarter of 2005 to begin trials for treatment of patients with advanced pancreatic cancer in both the US and EU. In October 2004, the FDA and EMEA each granted the Company orphan drug status for CoFactor for the treatment of pancreatic cancer in the US and EU, respectively. About CoFactor CoFactor (5,10-methylenetetrahydrofolate) is a biomodulator designed for use with 5-FU, a commonly used cancer drug. CoFactor is the active metabolite of leucovorin that bypasses the chemical pathway required by leucovorin to deliver the correct form of folate folate /fo·late/ (fo´lat) 1. the anionic form of folic acid. 2. more generally, any of a group of substances containing a form of pteroic acid conjugated with l-glutamic acid and having a variety of substitutions. to cancer cells, allowing 5-FU to work more effectively. In previous Phase II trials in Europe, CoFactor was administered to metastatic colorectal cancer patients 20 minutes before intravenous administration of 5-FU. In these European trials, CoFactor improved survival and time-to-tumor-progression while lowering toxicity in metastatic colorectal cancer patients. About ADVENTRX ADVENTRX Pharmaceuticals, Inc. is a biopharmaceutical research and development company whose business strategy is to commercialize leading edge medical research through licensing agreements with prominent universities and research institutions. The Company focuses on cancer and antiviral research to launch products that either extend the usefulness of current therapies or replace marginal therapies with new approaches to treatment. More information on ADVENTRX can be found on www.adventrx.com. Forward Looking Statement This press release contains forward-looking statements within the meaning of 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. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. and other regulatory agencies. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof. |
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