|July 11, 2002
|HEMISPHERX REPORTS AMPLIGEN DATA DEMONSTRATING A MEDIAN HAART-FREE (STI) INTERVAL OF 25+ WEEKS AT INTERNATIONAL AIDS CONFERENCE IN BARCELONA
|Median Duration of Strategic Treatment Intervention (STI) with Ampligen is 25+ weeks vs. 7 weeks for the control group.
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 720, designated RE-ARM 2.
There is an urgent need for a treatment with unique mode of action to overcome the multi-drug resistance and serious drug toxicities of the current highly active antiretroviral therapy (HAART). The study is designed to address this issue by the administration of the Company’s lead experimental product Ampligen, a double stranded RNA drug acting potentially as an immunomodulator and antiviral. Based on in vitro studies, Ampligen is believed to stimulate the immune system as well as destroy viruses directly. The importance of potential immune-based therapies is such that the Conference contained a special track dedicated to presentations of possible therapies based on the reconstitution of the immune system, during which Hemispherx presented the most clinically advanced data on immune mechanisms.
In this Phase IIb prospective, randomized controlled study, individuals with a HIV count of less than 50 copies per milliliter of blood and a CD4 count over 400 are taken off their HAART regimen and randomized 1:1 to undergo up to three STIs with Ampligen or without Ampligen (control group). The STI is discontinued and HAART restarted when HIV rebounds to 5000 copies/ml or more for three consecutive weekly determinations or to 50,000 copies/ml or more once. Based on a more recent study by, among others, Harvard Medical School and published in the Journal of Clinical Investigation in March of this year, validates the necessity of this trial, namely a need to introduce an immunotherapeutic into the “HAART free interval”.
In overview, the data presented showed that patients taken off HAART but given Ampligen continued to show virus levels below 5000 copies/ml for a median time of 25 weeks and counting, whereas the control group, which was also taken off HAART but not given Ampligen had a HIV rebound in a median of 7 weeks. Ampligen was generally well tolerated.
Dr. William A. Carter, CEO of the Company, commented on the significance of the results as follows. “We believe that immune-based therapies may be the next step in the treatment of chronic diseases, such as HIV/AIDS. These results demonstrate that Ampligen, as an experimental immunotherapeutic, is well tolerated and can potentially maintain “undetectable” virus levels in certain patients. Our experimental approach may relieve the potentially toxic side effects of the HAART regimen.”
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).
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.