Press Release: Globe Newswire, November 19, 2013
PHILADELPHIA, Nov. 19, 2013 (GLOBE NEWSWIRE) — Hemispherx Biopharma (NYSE MKT:HEB) announced its sponsorship of the Conference on "Diagnosis, Treatments and New Developments in ME and CFS" ("Myalgic Encephalomyelitis" and "Chronic Fatigue Syndrome") which will be held on November 20th beginning at 11 AM (EST) at the New York Academy of Medicine, 1215 Fifth Avenue/103(rd) Street, New York, NY. The program is the second symposium by The ME and CFS Center at Mount Sinai Medical Center in New York, which is headed by CFS expert, Dr. Derek Enlander.
Clinical and research experts will present information on current treatment options, including the most promising experimental drugs and the latest research findings, that provide insights into the diagnosis of this disorder. The speakers include Dr. Nancy Klimas, Institute for Neuro Immune Medicine at Nova Southeastern University; Dr. Daniel Peterson, Sierra Internal Medicine; Dr. Judy Mikovits, Dr. Eric Schadt, Institute for Genomics and MultiScale Biology at Mount Sinai Hospital; and Dr. Derek Enlander. The Q&A panel being held during the symposium will include Dr. Francis Ruscetti, National Institute of Health and Dr. Christian Becker, Critical Care Medicine in New York.
Patient advocates attending the symposium will examine the scientific and medical findings in light of the new Food and Drug Administration ("FDA") regulations codified in 2013. These new regulations may provide the FDA with accelerated pathways to advance experimental treatments for patients with chronically debilitating diseases; especially where there are little or no existing treatments.
Currently, there are no FDA approved treatments for Chronic Fatigue Syndrome. The FDA declared it a public health issue on a recent public conference call with the ME/CFS patient community. The disease afflicts at least 1 million Americans and affects 3 times as many women as men. The disease is also seen in children and teens. The recent Voice of the Patient Report on ME/CFS put out by the FDA captures day to day challenges faced by the patients with this complex disorder including cognitive dysfunction, gastrointestinal symptoms, severe fatigue and post-exertional crashes. Over 25% of the patients are house-bound or bed bound with the chronic effects being felt for decades. Research has shown that after years of illness, many of these patients die prematurely from cancer, heart failure and suicide. The national cost of this disease has been estimated by the Centers for Disease Control at $23 billion annually.
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(R) and the experimental therapeutics Ampligen(R) and Alferon(R) LDO. Ampligen(R) 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(R) and Alferon(R) 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(R)), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection(R) 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(R) approval in Argentina includes the use of Alferon N Injection(R) (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.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "potential," "potentially," "possible," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks 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. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.
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(R) NDA for the treatment of Chronic Fatigue Syndrome in the United States. The production of new Alferon(R) 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(R), this status will need to be reaffirmed upon the completion of the facility's enhancements 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(R) 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(R) 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(R) 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. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes 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. The final results of these efforts could vary materially from Hemispherx's expectations.