PHILADELPHIA, June 07, 2016 (GLOBE NEWSWIRE) -- Dr. William Mitchell, M.D., Ph.D., Chairman of the Board of Directors for Hemispherx Biopharma (NYSE MKT:HEB) and a Professor of Pathology, Microbiology and Immunology at Vanderbilt University, recently published an article entitled, “Efficacy of Rintatolimod in the Treatment of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME),” in Expert Review of Clinical Pharmacology, 2016 Jun;9(6):755-70. doi:10.1586/17512433.2016.1172960.
Rintatolimod (Ampligen®, Poly I : Poly C12U) is an experimental treatment for Chronic Fatigue Syndrome/Myalgic Encephalitis (CFS/ME) 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 in total with Ampligen®.
According to the article’s abstract, CFS/ME is a poorly understood seriously debilitating disorder in which disabling fatigue is a universal symptom in combination with a variety of variable symptoms. The only drug in advanced clinical development is rintatolimod, a mismatched double stranded polymer of RNA (dsRNA). Rintatolimod is a restricted Toll-Like Receptor 3 (TLR3) agonist lacking activation of other primary cellular inducers of innate immunity (e.g. cytosolic helicases). Rintatolimod also activates interferon induced proteins that require dsRNA for activity (e.g. 2ʹ-5ʹ adenylate synthetase, protein kinase R). Rintatolimod has achieved statistically significant improvements in primary endpoints in Phase II and Phase III double-blind, randomized, placebo-controlled clinical trials with a generally well tolerated safety profile and supported by open-label trials in the United States and Europe. At the current stage in the NDA review, the FDA has requested additional clinical data to be generated prior to potential approval of rintatolimod for commercial sale in the U.S. The chemistry, mechanism of action, clinical trial data, and current regulatory status of rintatolimod for CFS/ME including current evidence for etiology of the syndrome are reviewed.
William M. Mitchell, M.D., Ph.D., was appointed Chairman of the Board in February 2016 after serving as an independent Director since July 1998. He remains as an independent Director. Mitchell is a Professor of Pathology, Microbiology and Immunology at Vanderbilt University School of Medicine and is a board certified physician. Mitchell earned an M.D. from Vanderbilt and a Ph.D. from Johns Hopkins University in Biochemistry, where he served as a House Officer in Internal Medicine (Osler Service), followed by a Fellowship at its School of Medicine. Mitchell has published over 200 papers, reviews and abstracts that relate to viruses, anti-viral drugs, immune responses to HIV infection, and other biomedical topics. Dr. Mitchell has worked for and with many professional societies that have included the American Society of Investigative Pathology (ASIP), the International Society for Antiviral Research (ISAR), the American Society of Biochemistry and Molecular Biology ASBMB), the American Society of Microbiology (ASM), and the American Society of Clinical Oncology (ASCO). Mitchell is a member of the American Medical Association (AMA). He has served on numerous government review committees, including the National Institutes of Health (NIH), the Centers for Disease Control (CDC), The European Union (EU), and the private national laboratory regulatory group, the College of American Pathology (CAP). Dr. Mitchell previously served as one of our Directors from 1987 to 1989. He serves in addition as an independent Director of Chronix Biomedical, Inc., a cancer genetics laboratory company.
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.
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.
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.
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Source:Hemispherx Biopharma, Inc.