Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
PRNewswire - December 16, 1999
According to findings presented today at the Search for a Cure Conference in Boston, multiple HIV genetic mutations that made the 14 anti-HIV drugs approved by the Food and Drug Administration (FDA) ineffective did not diminish the pronounced anti-viral effectiveness of Ampligen(R). For example, viral resistance to all members of the newest class of powerful HIV inhibitors -- termed protease inhibitors -- were completely overcome by Ampligen(R).
Of the nearly 345,000 patients receiving anti-HIV treatment in the U.S., an estimated 60% have failed with their current drug regimen, in part due to the development of drug resistance caused by viral mutations.
These results, developed by independent researchers at the University of California at Irvine, were presented as a companion paper to a new report that found that Ampligen(R) provided potent antiviral therapeutic synergy against the unmutated form of the virus with 12 of the 14 available FDA-approved anti-HIV drugs.
The new test tube studies examined various concentrations of the different drugs and multiple strains of highly drug-resistant HIV (isolated from HIV-infected individuals in the U.S.) under conditions designed to simulate the clinical situation. In some of the tested cases, HIV resistance to available antiretroviral drugs actually increased more than 20,000 times, such as to the newer protease inhibitors, without altering the anti-viral effectiveness of Ampligen(R) in any detectable way.
"It is sobering to realize that the so-called highly active antiretroviral therapy (HAART) is actually not always active enough," said William A. Carter, Chairman and Chief Executive Officer of Hemispherx. "As we strive to induce a remission and to eradicate HIV, we need as physicians to consider why and how a well-documented small fraction of HIV-infected individuals, termed 'clinical non-progressors,' escape the AIDS-defining events indefinitely, sometimes even without the benefit of HAART.
"Recent studies suggest," Dr. Carter added, "that the immune systems of these protected individuals are really working differently, and they seem to manipulate HIV more like a herpes virus infection, such as cold sores, rather than as a lethal infection. The overarching question is how can immune-based therapy help drug (HAART) therapy to achieve a similar highly favorable outcome?"
Because double-stranded RNA technology, which includes Ampligen(R), represents a new mechanism of immune action distinctly different from that of any of the available 14 FDA-approved drugs, it is a most promising area for further investigation.
Hemispherx Biopharma, Inc. is a biopharmaceutical company specializing in new therapeutic approaches to HIV/AIDS, Chronic Fatigue Syndrome (CFS) and hepatitis B/C utilizing the immune system. It has offices in Philadelphia, Belgium and France and new drug development facilities in the Washington, D.C., area. Hemispherx was recently listed on the "Russell 2000" Index of small capitalization stocks.
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 risks of competition, changing market conditions, changes 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, actual results may differ materially from those in any forward-looking statements.
SOURCE Hemispherx Biopharma, Inc.
CONTACT: William A. Carter, M.D., CEO & Chairman of Hemispherx Biopharma, Inc., 215-988-0080; or William Jenks of Broadgate Consultants, 212-232-2222, or fax, 212-232-3232; or Diane Will, Investor Relations, 214-954-9300, or fax, 214-954-9333, both for Hemispherx Biopharma
Web Site: http://www.hemispherx.com/
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