HEB NEWS New Infectious Retrovirus Detected in Chronic Fatigue Syndrome
May Clarify Mechanism of Action of Hemispherx's Ampligen(R)
* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 8:15 am EDT, Tuesday October 13, 2009
Companies:
o Hemispherx Biopharma, Inc.
PHILADELPHIA, Oct. 13, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") announced today that the discovery of a novel retrovirus in CFS may now shed new light on the potential mechanism of action of Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic, in CFS. CFS is a debilitating disease of unknown etiology that is estimated to affect 17 million people worldwide. In the October 8, 2009 issue of Science Express, a consortium of researchers from the Whittemore Peterson Institute, the National Cancer Institute and the Cleveland Clinic report a new retrovirus in the blood cells of 67% of Chronic Fatigue Syndrome (CFS) patients and 3.7% in healthy control subjects. The infectious virus was also greater than 99% identical to that previously detected in prostate cancer. Patients with CFS are known to display various abnormalities in immune system functions and experience both higher cancer rates and neurological pathology, all of which may be associated with several retroviruses such as HIV and HTLV-1.
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Presently, the Company is actively collaborating with the Whittemore Peterson Institute to evaluate the potential role of Ampligen(R), an experimental therapeutic, in the clinical treatment of CFS patients who have a specific deficiency in Natural Killer (NK) cell activity. Immunosuppression is often seen in CFS patients and may be a feature of many retroviruses in animal and man. Phase III clinical studies have been conducted in CFS and a New Drug Application (NDA) is presently pending before the United States Food and Drug Administration (FDA).
Ampligen(R) (Poly I : Poly C12U), an experimental therapeutic, was in fact originally developed as a broad-spectrum antiviral/immunomodulator, and has previously demonstrated bioactivity against retroviruses in model systems.
The Company stated that an update on its CFS programs will be provided at the upcoming Health and Human Services CFS Advisory Committee in Washington, D.C. in November, 2009.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit 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. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) 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. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
