ADVENTRX Granted Clearance in the UK for CoFactor Phase IIb Metastatic Colorectal Cancer Trial.SAN DIEGO -- ADVENTRX Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :ANX) today announced that it has received clearance from the Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. (MHRA) to begin an international Phase IIb 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 clinical trial controlled clinical trial, n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo. 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) with 5-fluorouracil (5-FU) in metastatic colorectal cancer in the United Kingdom. The Company expects to begin patient enrollment for this trial by the end of April 2005. 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. "This clearance comes on the heels of meeting our primary clinical endpoint for response rate with our ongoing US CoFactor Phase II trial in metastatic colorectal cancer," said Evan M. Levine, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of ADVENTRX. "This is an important step in the overall late stage clinical development of CoFactor and we look forward to launching this Phase IIb trial in the UK and other countries involved. We also look forward to launching two Phase III pivotal trials for CoFactor; one for metastatic colorectal cancer in the US; and one for pancreatic cancer in Europe." This Phase IIb study is an international, multi-center, open label, randomized, controlled clinical trial to evaluate the safety and efficacy of treatment with CoFactor plus 5-FU in patients with metastatic colorectal carcinoma. ADVENTRX plans to conduct this trial in the UK, Germany, Romania, Poland, Serbia, India and Croatia. Approximately 300 patients will be randomized to receive either CoFactor plus 5-FU or leucovorin plus 5-FU. The primary endpoint for this trial is defined as reduction of grade 3 or greater toxicity as defined by the NCI See Liberate. Common Terminology Criteria for Adverse Events (version 3) in the CoFactor/5-FU arm over the leucovorin/5-FU arm. Secondary endpoints are response rate, time to progression, and quality of life. The global principal investigator for the trial is Professor James Cassidy, M.D., MBChB, MSc, FRCP FRCP Fellow of the Royal College of Physicians. FRCP abbr. Fellow of the Royal College of Physicians . Dr. James Cassidy is Professor of Oncology and Head of the Department of Cancer Research in the UK Department of Medical Oncology at the University of Glasgow The University of Glasgow (Scottish Gaelic: Oilthigh Ghlaschu, Latin: Universitas Glasguensis) was founded in 1451, in Glasgow, Scotland. in Glasgow, Scotland. Professor Cassidy has published over 140 peer-reviewed articles in scientific and medical journals and has led high profile oncology clinical studies, including most recently the X-ACT X-ACT XML Active Content Technologies Council study. "We are pleased that an investigator of Dr. Cassidy's caliber has agreed to lead this clinical trial as he brings significant experience in conducting novel drug development in colorectal cancer therapeutics," said Cellia Habita, M.D., Ph.D., senior vice president of medical and clinical affairs of ADVENTRX. ADVENTRX has filed for clearance to initiate a Phase III trial in the US with CoFactor in metastatic colorectal cancer and currently plans to file in the first half of this year for clearance to initiate an EU-based Phase III study in pancreatic cancer. About CoFactor CoFactor is a folate-based biomodulator developed to enhance the activity of the widely used cancer chemotherapeutic, 5-FU. Data from previous clinical trials in Europe have demonstrated clinical benefit and improved overall median survival in patients with advanced tumors, including colorectal, pancreatic and breast. CoFactor creates more stable binding, compared to leucovorin, of the active form of 5-FU, FdUMP, to the target enzyme, thymidylate synthase. CoFactor bypasses the chemical pathway required by leucovorin to deliver the active 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. which allows 5-FU to work more effectively. This improves 5-FU performance and lowers toxicity. More information on CoFactor can be found at http://www.adventrx.com/products/antic_cofactor.htm. About ADVENTRX ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance of existing drugs and address significant problems such as drug metabolism, bioavailability and resistance. More information can be found on the Company's Web site at 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 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. and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's last quarterly report on Form 10-QSB, as well as other reports that the Company files from time to time with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. 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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