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ADVENTRX Pharmaceuticals, Inc. Announces its Contract Research Organization Agreement for Phase Ib/IIa Clinical Trials for its HIV Viral Entry Inhibitor - Clinical Trial Anticipated to begin in September




 

SAN DIEGO, July 22 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (OTC Bulletin Board: AVRX) announced today that after completing manufacturing of its viral entry inhibitor for HIV, known as BlockAide/CR(TM), it has signed an agreement with Synteract, Inc., a Contract Research Organization (CRO) headquartered in Carlsbad, California, to coordinate its Phase Ib/IIa human clinical trial, which is scheduled to begin in September.

"We are pleased to be working with Synteract as our CRO for this initial human clinical trial of BlockAide/CR," said Dr. Joan Robbins, ADVENTRX Pharmaceuticals' Chief Technical Officer. "Synteracts' comprehensive capabilities, from protocol development and site management to data collection, electronic submissions, and safety surveillance will give us all the necessary tools to properly and rapidly implement the study of our drug in HIV infected individuals."

BlockAide/CR is a synthetic peptide drug, based upon the structure of the V3 loop of HIV, which the virus uses to bind to cell surface lipids as part of its infection process before viral fusion takes place. BlockAide/CR competitively inhibits the interaction of the V3 loop with host cell lipids, which is a common mechanism for entry and infection of diverse HIV-1 strains, and thus prevents infection of treated immune system cells.

In preclinical development, BlockAide/CR was administered in daily doses to determine the effectiveness of this drug against acute infection with SHIV (simian human immunodeficiency virus) in an animal model. Viral load decreased 100-fold after approximately two weeks of treatment, with no observed toxicity. Based upon the success of this efficacy testing, including toxicity studies in four non-human animal models, and the receipt of newly manufactured drug product for human testing, the Company is finalizing its IND (Investigation New Drug) application for submission to FDA to gain approval to begin trials with Synteract as it designated CRO.

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.

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.

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.

SOURCE ADVENTRX Pharmaceuticals, Inc.

Web Site: http://www.adventrx.com



 


Copyright © 2003 -BBC News, Publisher. All rights reserved to BBC Reproduction of this article (other than one copy for personal reference) must be clered through the BBC.

Information in this article was accurate in July 22, 2003. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.