Business Wire - December 6, 2001
Hemispherx Biopharma, Inc. (AMEX:HEB), a leading company in the development of immune based therapies primarily addressing the diseases of Chronic Fatigue Syndrome and HIV AIDS indicated today, in response to inquiries on its bioterrorism program, that positive results have already been obtained from independent animal-based research performed at the Arbovirus Unit of Yale University in collaboration with the United States Army Medical Research Institute for Infectious Diseases regarding the efficacy a member of the Company's RNA drug platform, Ampligen(R) for the treatment of smallpox.
Ampligen(R), performed better than any of the other chemo-therapeutics in terms of reducing the number and severity of pox lesions (or severe skin sores) on the test animals. Ampligen(R) is in Phase III clinical trials in CFS and Phase IIB in HIV/AIDS.
The virus used, termed "Vaccinia Virus" is closely related to Smallpox virus. Indeed, Vaccinia Virus has been regularly injected into U.S. Military personnel to convey immunity against Smallpox. In the model Smallpox system, Vaccinia Virus caused skin lesions, or severe skin inflammations, whose severity was based on the particular virulence of the various strains of virus used.
According to the researchers "Ampligen(R) suppressed (inhibited) the lesions at very low doses." The researchers also undertook the studies to determine if various test medications (of which there were approximately 15 including RNA drug platform, Ampligen(R)), could lessen the potential dreaded side effects of Smallpox vaccination. The side effects include rapid spread of the virus from the vaccination site leading to death and other very serious complications.
In the United States alone, it is estimated that there are millions of people who are unable to take vaccination unless they would be protected from the dreaded vaccine side effects; this population includes patients with cancer, AIDS, organ transplantation and pregnant women.
The Company stated that, in view of the thousands of viruses which exist in nature, studies such as those conducted by the Military are necessary to evaluate therapeutic potential of any new drug or immunotherapeutic. In contrast, potential benefit may not be extrapolated from viruses which are unrelated to Smallpox, as has been recently reported in the public environment of growing concern for renewed bioterrorism, especially Smallpox.
The scientific article is entitled "Chemotherapeutic Prevention of Complications Caused by Vaccinia Virus-Vectored Immunogen" and is co-authored by scientists at the Yale Arbovirus Research Unit, Yale University School of Medicine, New Haven, CT and the U.S. Army Medical Research Institute of Infectious Diseases, Fort Dietrich, Frederick, MD. The results of the research are available in The Annals of the New York Academy of Sciences, Vol 653, and pages 334-343.
The research was supported by contract DAMD17-86-C-6042 of the U.S. Research and Development Command, Fort Dietrick, Frederick, MD.
The Company stated that these studies represented an example of successful outsourcing of research based on the sustained scientific interest and the Company's unique approach to immunotherapy of various viral diseases. The Company's core programs in CFS treatment and HIV treatment are managed internally while ancillary programs are typically implemented by collaborative research agreements.
The Company also indicated that while it is responding to the potential needs of the current emergencies in the aftermath of the events of September 11th 2001 with limited and strategic investigations into the use of its platform technology for the treatment of terroristically induced pathogens, it continues to focus its principal energies on the currently pending phase III clinical trials for its platform drug RNA drug platform, Ampligen(R), and for the treatment of chronic fatigue syndrome and its phase IIB trials of the same drug for HIV/AIDS.
About Hemispherx
Hemispherx Biopharma, based in Philadelphia, is a pharmaceutical company engaged in the manufacture and global clinical development of new drug entities in the nucleic acid (NA) class for chronic viral diseases and disorders of the immune system including CFS, HIV and hepatitis. Its flagship products are Ampligen(R) -- being developed for CFS and drug resistant HIV -- and Polyandenur being developed for hepatitis B and C. It is conducting phase III trials in CFS and phase IIb trials in HIV/AIDS. For more information visit the company's Web site at 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 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 including financial results may differ materially from those in any forward-looking statements. Additionally, 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.
CONTACT: Hemispherx Biopharma, Philadelphia William A. Carter, 215/988-0080 www.hemispherx.net or MRB Investor Relations Robert Giordano, 212/230-1727 rgiordano@mrb-ir.com
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