| July 11, 2002 |
| HEMISPHERX REPORTS NEW AMPLIGEN DATA DEMONSTRATING A MEDIAN 0.5 LOG DROP IN VIRAL LOAD AT INTERNATIONAL AIDS CONFERENCE IN BARCELONA |
Ampligen as an adjunct to HAART decreases HIV RNA levels by 0.50 Log after a median duration of 4.5 months.
Philadelphia, PA, Thursday, July 11, 2002: Hemispherx Biopharma, Inc. (AMEX:HEB), a leading company in the experimental-stage development of immune based therapies primarily addressing the diseases of HIV/AIDS and Chronic Fatigue Syndrome announced today that on July 11, 2002 at the XIV International Aids Conference, the world’s largest HIV/AIDS meeting, held in Barcelona, Spain, July 7-12, it presented an abstract on the most recent data of its Phase IIb clinical trial, AMP 719, designated RE-ARM 1.
The study is designed to evaluate the potential synergistic efficacy of, experimental stage immunotherapeutic, Ampligen administration in multi-drug resistant HIV infected population for immune enhancement as well as re-sensitization of the drug resistant patients to the medication on which they are failing due to the ability of the virus to mutate. A new study by the Osher Center for Integrative Medicine at the University of California, San Francisco shows that an alarming one in seven people newly infected with HIV contracted a strain of the virus that was resistant to at least two of the three major classes of the HAART regimen, that is a number that has quadrupled over the last six years.
The study is an open-label, prospective, randomized, controlled study of the safety and biological effects, including clinical, immunologic, and virologic assessments of adding Ampligen to HAART in HIV infected patients with HIV-1 plasma RNA over 500 and less or equal to 30,000 copies/ml. In order to develop early safety data, the first ten patients entered did receive Ampligen, and then the next patients are randomized 1:1 to initially receive Ampligen in addition to HAART regimen or remain on HAART alone (control group).
The data presented showed that after a median duration of 4.5 months, Ampligen patients on HAART have experienced a mean HIV-1 viral load decrease of 0.50 log using the Roche Amplicor assay. Adverse events with Ampligen have been generally well tolerated.
Dr. William A. Carter, CEO of the Company, commenting on these significant results “ Mutations associated with resistance to the drugs of the HAART regimen are increasing dramatically. These results indicate a possible salvage for the multi-drug resistant HIV infected patients who otherwise might be started needlessly on potentially toxic therapies destined to be ineffective.”
ABOUT HEMISPHERX
Hemispherx Biopharma, Inc is a biopharmaceutical company that focuses on the innovative development of ribonucleic acid (RNA) drug technologies intended to enhance the natural anti-viral defense system of the human body, representing a potential new class of pharmaceutical products. Its primary product, Ampligen, is in two phase IIb clinical trials for HIV/AIDS, one experimental Salvage Therapy and one Strategic Treatment Intervention (STI), and a phase III clinical trial for Chronic Fatigue Syndrome (CFS).
Contact(s):
Hemispherx Biopharma, Inc., Investor Relations
(215) 988-1712, Fax: (215) 988-1554
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6223
Robert Giordano, MRB Institutional Investors, MRB
(212) 495-0200, Fax: (212) 495-0746
HEB's Web Site: www.hemispherx.net
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. Accordingly, all the referenced investigational drugs and associated technologies of the company are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. |
|
