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PRESS RELEASES ADVENTRX PHARMACEUTICALS, Inc. Announces Plans for Phase Ib/IIa Human Clinical Trail in HIV Company commences manufacturing of EradicAide– peptides in Preparation for IND Filing SAN DIEGO – June 26, 2003 – ADVENTRX PHARMACEUTICALS, INC. (OTCBB:AVRX - News) announced today that it has initiated manufacturing of peptides that comprise its therapeutic vaccine for HIV, known as EradicAide, in order to prepare pharmaceutical grade product to dose HIV infected patients in a Phase Ib/IIa human clinical trial. The Company plans to file an IND later this year. Peptisyntha of Torrance, California will manufacture the peptides for EradicAide in its R&D and GMP-compliant manufacturing facilities. "We are confident that Peptisyntha will play an important role in helping us implement this trial, where our goals are to demonstrate the same safety and efficacy we observed in pre-clinical studies." said Dr. Joan Robbins, Adventrx Pharmaceuticals' Chief Technical Officer. "We expect that the results achieved in over five years of animal testing will translate to human protocols that could prove to be useful for third world treatment. Along those lines, we continue to work on an oral formulation of EradicAide under a U.S. government grant, which began earlier this year." EradicAide is a therapeutic vaccine with a peptide formulation that does not stimulate the production of antibodies. Antibodies have been shown to enhance HIV infection in studies designed to observe how HIV spreads. Antibody-based vaccines have achieved only mixed results in human testing. In contrast, EradicAide is based upon a cell-mediated immunity approach to controlling HIV, by stimulating disease-fighting cells called killer-T cells whose job it is to clear infection. Studies of long-term nonprogressors, individuals who are HIV-infected but do not get AIDS, have identified certain cell-mediated immunity characteristics of these individuals that allow them to control HIV. EradicAide peptides are designed to induce the killing of HIV-infected cells, similar to the immune system of long-term nonprogressors. Success of this approach has been demonstrated in extensive primate studies where animals were infected with SHIV (Simian Human Immunodeficiency Virus) and have been able to keep infection under control for up to three years with a single series of treatments. The Company believes these animal results will translate to superior results in upcoming human trials, since the animal testing has been broadly successful against acute levels of infection. About Peptisyntha, Inc. Peptisyntha, Inc. was created in August 2001, as a wholly-owned subsidiary of Solvay America, Inc. to serve as a US-platform to initiate and develop R&D and commercial contracts in the US market for peptide-based drugs. Peptisyntha, Inc. is located in Torrance, California where it has full R&D and cGMP manufacturing capabilities for solid-phase manufacturing of peptides. Its expertise is further enhanced by Peptisyntha S.A. of Belgium, a leading manufacturer of peptides with proprietary solution-phase technology, which enables the cost-effective scale up of commercial quantities required by the biopharmaceutical industry. 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 antiviral and anticancer 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 Jon Virca, 858/271-9671, Fax 858/271-9678 virca@adventrx.com or CEOCast Inc. for Adventrx Pharmaceuticals Inc. Matthew Henderson, 212/732-4300 mhenderson@ceocast.com |
