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globenewswire

Hemispherx Biopharma to Present New Ampligen(r) Clinical Data At the 9th International IACFS/ME Conference

Clinical/Lab Parameters of Potential Special Import to CFS Disease Severity

  • Press Release
  • Source: Hemispherx Biopharma, Inc.
  • On 1:54 pm EST, Wednesday February 18, 2009

PHILADELPHIA, Feb. 18, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB - News) announced its medical director, Dr. David Strayer, will present new data on Ampligen(r) (Poly I: Poly C12U) at the upcoming International Association of Chronic Fatigue Syndrome (IACFS/ME) in Reno, NV March 13, 2009. The mission of IACFS/ME is to promote, stimulate and coordinate the exchange of ideas related to CFS/ME research, patient care and treatment.

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The oral presentation will include new data from the ongoing treatment IND/compassionate study (AMP 511) as well as the completed well-controlled pivotal Phase III study (AMP 516). Ampligen(r), an investigational stage therapeutic, has a pending New Drug Application (NDA) filed with the Food and Drug Administration (FDA) with an extended user fee goal of May 25, 2009.

Individuals suffering with CFS are known to be at greater risk than age-matched healthy populations with respect to certain catastrophic events including cancer, sudden cardio-vascular death and suicidal ideation. The new data will evaluate the potential of Ampligen(r), an experimental therapeutic, to mitigate certain of these events. Data utilized will integrate serially performed immunologic lab panels and EKGs, as well as physical performance scores and medical records (including concomitant medications used to alleviate certain symptoms of CFS).

Ampligen(r), an experimental product, may modulate nature's primary gateway to immune response, mediated by receptors termed ``toll-like receptors'' (TLRs). Many other immuno-modulators may work downstream from the TLRs immune ``gateways'' at so-called ``checkpoints''. Since ``checkpoints'' are not normally part of nature's own immune-defense surveillance apparatus, these alternative ``checkpoint'' strategies may be associated with unintended consequences including significant toxicities.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is a specialty pharma 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) and Oragens(r). 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 issued 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 http://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 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(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.

Contact:

          Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net

CCG Investor Relations
Sean Collins, Sr. Partner
310-477-9800

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