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PRESS RELEASES ADVENTRX Pharmaceuticals Receives FDA Clearance for HIV Viral Entry Inhibitor to Begin Phase Ib/IIa Human Clinical Trial SAN DIEGO, April 15, 2004 – ADVENTRX Pharmaceuticals, Inc. (OTCBB: AVRX) announced today that the Investigational New Drug Application (IND) for its HIV-1 entry inhibitor, BlockAide/CR™, received FDA clearance to begin a Phase Ib/IIa human clinical trial. The trial will assess safety, pharmacokinetics and effect on viral load of BlockAide/CR in HIV-1 positive individuals with evidence of increasing viral load despite treatment with other antiretroviral therapy. "We were encouraged by preclinical studies that showed BlockAide/CR was safe and active against multiple HIV strains," commented Joan M. Robbins, Ph.D., ADVENTRX Chief Technical Officer. "With toxicities associated with current treatment regimens and viral resistance continuing to be a major problem, there is an indisputable need for alternative treatment options. We are hopeful that BlockAide/CR can address these issues." BlockAide/CR is a synthetic 15 amino acid peptide, which mimics a portion of HIV-1 that is responsible for entry into the immune system cell. The BlockAide/CR peptide binds to immune system cells, preventing co-receptor interaction necessary for HIV fusion and entry. Since BlockAide/CR binds to immune system cells to inhibit viral entry rather than binding directly to HIV, BlockAide/CR may be less susceptible to problems with viral resistance associated with other viral entry inhibitors and HAART (highly active antiretroviral therapy) drugs. The clinical study is planned to be conducted at the VA San Diego Healthcare System under the direction of David J. Looney, M.D., Principal Investigator, Veterans Medical Research Foundation. Drug safety and effects on HIV viral load and CD4+ T cell count will be determined. 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 and BlockAide/CR can be found on the Company's website at www.adventrx.com. 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. Contacts: The Ruth Group Investors: Stephanie Carrington 646-536-7017 Media: Cynthia Isaac, Ph.D. 646-536-7028 Study related: Cellia Habita, M.D., Ph.D. VP, Medical and Clinical Affairs ADVENTRX Pharmaceuticals 858-271-9671 |
