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ADVENTRX Pharmaceuticals and Synteract Announce Agreement
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SAN DIEGO, Ca - October 15, 2003 (PRNewswire-FirstCall) - ADVENTRX
Pharmaceuticals, Inc. (OTC Bulletin Board: AVRX) announced today that it 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.
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"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."
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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.
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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 U.S. of only six percent.
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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 the Carlsbad, CA, 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.
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About ADVENTRX Pharmaceuticals - 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.
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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.
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