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PRESS RELEASES ADVENTRX Pharmaceuticals, Inc. Enters into Agreement with Leading Contract Research Organization for Phase II Clinical Trials of CoFactor™ Company Seeks to Replicate Promising Results from Cancer Drug's Trial in Europe: U.S. Trial to Begin This Quarter. SAN DIEGO – October 15, 2003 PRNewswire-FirstCall – ADVENTRX Pharmaceuticals, Inc. (OTC Bulletin Board: AVRX) announced today that is has signed an agreement with Synteract, Inc., a Contract Research Organization (CRO) headquartered in Carlsbad, California to coordinate its Phase II human trial for CoFactor, the company's lead cancer compound. "We have chosen Synteract as our CRO to conduct our second Phase II trial of CoFactor", said Dr. Joan Robbins, ADVENTRX Pharmaceuticals' Chief Technical Officer. "Synteract's comprehensive capabilities in the area of oncology, including site management, data collection, electronic submissions and safety surveillance will greatly assist our clinical researchers in documenting and reporting the results of our first trial in the US for CoFactor. We are excited that this is an opportunity for us to replicate the success we reported in our European Phase II study." In previous Phase II trials in Europe, a 100 mg. dose of CoFactor, given 20 minutes before IV administration of the chemotherapy agent 5-FU, was able to extend the median time to tumor progression in metastatic colorectal cancer patients to 14.7 months and median survival to 21.5 months, which represents a seven month improvement over currently approved first-line therapy in the United States. No hospitalizations were required due to the very low toxicity of the regimen. Synteract will monitor the open-label Phase II trial of newly diagnosed metastatic colorectal cancer patients as an alternative to the current, more toxic therapy that is now used. Data will be compiled and reported on each patient after only two cycles of therapy assessing tumor response, as a primary endpoint, and time to tumor progression and survival as secondary endpoints. Metastatic colorectal cancer has a survival rate in the US of only six percent. For more information and to view a demonstration of CoFactor, visit www.adventrx.com. About Synteract Established in 1995, Synteract is a privately-held, full-service contract research organization, dedicated to meeting the various needs of biotechnology, biomedical, pharmaceutical, and drug industry firms. Based in Carlsbad, California, with a branch office in Pennsylvania, the Company provides expertise in a wide range of therapeutic areas and maintains a wealth of knowledge in oncology, ophthalmology, HIV, erectile dysfunction, cardiovascular disease, and pain. Since 2000, it has been a key development shop for web, wireless and voice data solutions that speed the completion of clinical trials and assist in access to clinical trials information. This includes technologies such as electronic data capture (EDC), interactive voice response systems (IVRS), and automated safety tracking and reporting. 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 its energy in cancer and antiviral research to launch products that either extend the usefulness of current therapies or replace marginal therapies with new approaches to treatment. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act 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. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof. Contact: ADVENTRX Pharmaceuticals, Inc. Nicholas J. Virca, 858/271-9671 Fax: 858/271-9678 Virca@adventrx.com CEOCast, Inc. for ADVENTRX Pharmaceuticals Ken Sgro, 212/732-4300 Fax: 212/732-1131 kensgro@ceocast.com |
