Hemispherx Reports Reviewed Ampligen Data for NINDS

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Hemispherx Biopharma (NYSE MKT:
HEB
) (the "Company" or "Hemispherx") announced that the strong commitment by the National Institutes of Health (NIH) to advance research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) signals a major research effort by NIH in the diagnosis and treatment of this complex and poorly understood life-robbing disease. Lead by NIH Director Francis S. Collins, M.D., Ph.D., the NIH held an open call with the ME/CFS patient community March 8 to detail some of those efforts. Collins reaffirmed that the agency's goals include both intramural and extramural research. To start, NIH has already launched a research protocol at its Clinical Center to intensely study individuals with ME/CFS and has re-invigorated the efforts of the long-standing Trans-NIH ME/CFS Research Working Group with the National Institute of Neurological Disorders and Stroke (NINDS) as the lead of a multi-institute research effort. "Our recent meeting with Dr. Koroshetz and members of the Trans NIH working group allowed us to review Ampligen® studies to date and discuss how the NIH's research may assist us in closing key questions from the FDA," said Thomas K. Equels, CEO of Hemispherx Biopharma. "We were pleased the open forum allowed NIH to discuss the science and their commitment toward advancing treatment." Walter Koroshetz, M.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), shared the institute's plans to include universities and companies in the quest to find solutions to what he called "a difficult problem." Vicky Whittemore, Ph.D., who heads the Trans-NIH ME/CFS Research Working Group stated that experts from more than 20 NIH Institutes will be collaborating to examine key areas such as biomarkers, cause and mechanisms as well as symptoms such as brain fog. In February 2015, the Institute of Medicine (IOM) published a report, Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Redefining an Illness. The IOM committee was charged by the US Department of Health and Human Services (HHS) with evaluating the current criteria for the diagnosis of ME/CFS and recommended clinical diagnostic criteria that would address the needs of health care providers, patients, and their caregivers. Between 836,000 and 2.5 million Americans suffer from ME/ CFS. This disease is characterized by profound fatigue, cognitive dysfunction, sleep abnormalities, autonomic manifestations, pain, and other symptoms that are made worse by exertion of any sort. ME/CFS can severely impair patients' ability to conduct their normal lives. Ampligen® is an experimental treatment for ME/CFS and the only such product to date to complete both Phase II and Phase III clinical trials. In May 1997, the FDA authorized an open-label treatment protocol, ("AMP-511"), allowing patient access to Ampligen® for treatment in an open-label safety study under which severely debilitated CFS patients have the opportunity to receive Ampligen® treatment. More than 800 patients with CFS have been treated with Ampligen®.
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