Palm Beach, FL 1/11/12 (StreetBeat) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced today that the Food and Drug Administration granted an extension for the Company to modify its New Drug Application in response to a Complete Response Letter received November 25, 2009 for the Chronic Fatigue Syndrome 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 and Harvard University reported new data on the magnitude of medical and economic impact of untreated CFS. 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(R) as the first treatment for Chronic Fatigue Syndrome in the U.S. and other countries," stated Dr. David Strayer, Medical Director for Hemispherx.
Shares of Hemispherx are trading at $0.25, up $0.04 or 18%, following the news.
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