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Philadelphia, PA, Thursday, January 14, 2010: Hemispherx Biopharma provides Grant to IACFS to assist in the Development of
Chronic Fatigue Syndrome (CFS) Clinical Guidelines
Philadelphia, PA - January 14, 2010 - Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the “Company” or “Hemispherx”), announced that it has provided an un-restricted grant to the International Association for Chronic Fatigue Syndrome (IACFS). “The grant is being provided to assist IACFS in their continued research and advocacy work and to support an upcoming workshop to develop clinical guidelines for chronic fatigue syndrome,” stated Dr. William Carter, CEO. “We are pleased to contribute to such an important effort – the care and treatment of CFS patients. Having worked in this area for more than two decades, we understand the complex nature of this disease and the need for educating healthcare professionals”.
According to several prevalence studies, about one million Americans have Chronic Fatigue Syndrome. “Since the breakout of CFS in the mid 1980’s, there has been a need for CFS Clinical Guidelines,” stated Dr. Nancy Klimas of IACFS. “One of the largest problems, beyond the diagnosis of CFS, is finding a clinician who is able to provide effective care and treatment for CFS based on the latest evidence based medical information”.
Over the years testimony has been provided to the Health and Human Services Chronic Fatigue Syndrome Advisory Committee about the problems with access to care including:
Long waiting lists for appointments with CFS experts
Lack of health care providers who understand and are able to care for CFS patients
Frustration with the treatment guidelines set by the CDC
And no FDA approved treatments for CFS
The goal of this workshop, which will be attended by some of the top experts in the field, is to establish clinical guidelines for CFS that are consistent with the current research in multiple disciplines. The workshop is expected to generate a publishable tool that can be used by practitioners. Potentially, a well developed set of recognized guidelines can lead to increased availability of quality clinical care for these medically under-served and often long-suffering patients.
Chronic Fatigue Syndrome is an enigmatic and debilitating illness that has been recently linked to a new retrovirus. Researchers are investigating the possible role of this virus in the symptomatology of the disease and, in some studies, are using Ampligen® as an investigational therapeutic.
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® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® Oragens®, and Alferon LDO. Ampligen® and Oragens® 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®). 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.
About IACFS/ME
The IACFS/ME is a professional organization of clinicians and scientists whose mission is to promote, stimulate and coordinate the exchange of ideas related to CFS, ME and fibromyalgia (FM) research, patient care and treatment. The IACFS/ME also conducts and/or participates in local, national, and international scientific conferences in order to promote and evaluate new research and to encourage future research ventures and cooperative activities to advance scientific and clinical knowledge of these illnesses. The IACFS/ME is a not for profit (502C3) organization. For more information, please visit www.IACFSME.org.
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Contact:
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: www.hemispherx.net
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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 completion of the NDA filing process with Ampligen® and the receipt of a Complete Response Letter from the FDA do not imply that the Company will be able to successfully comply with any or all of the requirements requested in that Letter or that Ampligen® will ever be approved for commercial sale. In addition, 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®, Alferon® LDO and Oragens®) 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® do not imply that the product will ever be specifically approved commercially for these other treatment indications. Similarly, the completion of the NDA filing process with Ampligen® does not imply that the product will ever be approved commercially.
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