PHILADELPHIA, Jan. 11, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") announced today that the Food and Drug Administration ("FDA") granted an extension for the Company to modify its New Drug Application ("NDA") in response to a Complete Response Letter ("CRL") received November 25, 2009 for the Chronic Fatigue Syndrome ("CFS") therapeutic indication. The extension will remain open while Hemispherx submits an amended NDA.
In year 2011, a team of researchers at the Centers for Disease Control ("CDC") and Harvard University reported new data on the magnitude of medical and economic impact of untreated CFS (Cost Effectiveness and Resource Allocation, vol. 9, 2011). According to the study, "CFS patients, their families, employers and society bear significant costs associated with the illness. The symptoms characterizing CFS are common to many illnesses, hence diagnosis is complex… and requiring extensive diagnostic testing and clinical assessment."
In the request for extension, the Company advised the FDA of the findings presented at the IACFS/ME Biennial Scientific Conference held September 22-25, 2011 in Ottawa, Ontario, Canada of a new potential companion diagnostic tests for CFS. The proof of principle study presented in Ottawa compared sequences from massively parallel sequenced serum DNA (Deoxyribonucleic Acid) extracted from either well vetted Hemispherx CFS sera or matching controls. Signature DNA sequences were identified that showed statistically significant separation of CFS serum from matching control serum. "We continue to move forward and are working diligently to pursue approval for Ampligen® as the first treatment for Chronic Fatigue Syndrome in the U.S. and other countries," stated Dr. David Strayer, Medical Director for Hemispherx.
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. 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.