PHILADELPHIA, Dec. 14, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") announced today that the Food and Drug Administration (FDA) granted a 12 month extension for the Company to modify its NDA in response to a Complete Response Letter (CRL) received November 25, 2009 for the CFS indication. In the request received by the Agency on November 24, 2010, the Company cited new clinical laboratory data on the possible inter-relationships of XMRV positivity and responsiveness of CFS to its experimental drug, Ampligen®, a toll-like receptor 3 agonist. The request included a new formal protocol titled "Analysis of XMRV Markers from the Serum Samples of all Evaluable Subjects of the Clinical Study AMP-516," which would extend the XMRV observations presented at the 1st International Workshop on XMRV held at the National Institutes of Health in Bethesda, MD, on September 7 and 8, 2010. In the request, Hemispherx pointed out that its ongoing analysis of XMRV in CFS would appear to be potentially most helpful in responding to certain aspects of the CRL as well as in pursuing the joint mission to offer potential novel treatments to CFS sufferers.
In a public disclosure of November 29, 2010, Hemispherx provided background information on these viruses termed "retroviruses," and cited the recent relevant peer-reviewed publications including ongoing research being conducted at the FDA and National Institutes of Health (NIH).
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® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid 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 an extensive number of 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.
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® and Alferon® LDO) 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. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications.