PHILADELPHIA, March 10, 2016 (GLOBE NEWSWIRE) -- 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®.
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® 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, including Chronic Fatigue Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company’s Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon”) for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. 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.
Forward-Looking Statements:
The foregoing release contains forward-looking statements that can be identified by words such as "will be, investigative, interim, potential" or similar terms, or by express or implied discussions regarding potential efficacy for Hemispherx’s Ampligen®, or regarding potential future revenues from Ampligen®. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of Management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ampligen® will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding Ampligen® could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors described in Hemispherx’s filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K on file with the U.S. Securities and Exchange Commission. Hemispherx is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Disclosure Notice:
The information in this press release includes certain "forward-looking” statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The production of new Alferon® API inventory will not commence until the capital improvement and validation phases are complete. While the facility is approved by FDA under the Biological License Application ("BLA”) for Alferon®, this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. The final results of these and other ongoing activities could vary materially from Hemispherx’s expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents obtained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; as well as numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx’s expectations.