PHILADELPHIA, Dec. 9, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced today that it has received a new research report (dated December 5, 2014) from researchers at Howard University, Washington DC. The report describes a study in which Ampligen® (Poly I : Poly C 12 U) strongly inhibited the Ebola minigenome in the human embryonic kidney cell system. The Ebola minigenome replication system was recently described by the researchers in the Journal of Biological Chemistry (2014) ( Role of Protein Phosphatase 1 in Dephosphorylation of Ebola Virus VP30 Protein and Its Targeting for the Inhibition of Viral Transcription ; Ilinykh et al. 289(33):22723-22738). In the minigenome replication system, certain genetic information for viral proteins has been deleted from the genomic array to permit safer and more efficient laboratory manipulations.
Most importantly, the current Howard University results taken in conjunction with previous data on anti-Ebola actions of Ampligen® reported by other US and European collaborators, indicate that the antiviral molecular actions of Ampligen® may be triggered at levels reached by the common human treatment regimens of Ampligen which have historically been used in clinical studies in a variety of other human diseases. These regimens of Ampligen®, an experimental therapeutic, have been deployed to date over 100,000 times in over 1,000 patients. Today's report also extends the histologic range of human cell types in which Ampligen® has demonstrated strong bioactivity against Ebola at low drug concentrations. Ebola is known to multiply in many different parts of the body destroying multiple types of cells, leading to high morbidity and mortality rates.
Recent articles in New England Journal of Medicine (November 27, 2014) emphasize that in subsets of severely ill EVD patients, parenteral therapy, rather than oral based treatments, will be necessary. Ampligen®, an experimental therapeutic, may be able to meet this requirement.
Previously, the Department of Life and Environmental Sciences, University of Cagliari, Italy reported that Ampligen® can successfully bind to the lethal EVD viral protein designated VP35. VP35 protein normally inactivates a patient's immune/antiviral system by binding to viral dsRNA thereby sequestering a critical antiviral/immune activator of the body which leads to high morbidity and death rates. The experimental outcome achieved by the Cagliari University is consistent with recent predictions published in the Nature group Emerging Microbes and Infections (3, e77; doi:10.1038/emi.2014.77; published online 29 October 2014) by affiliates of Hemispherx.
Another recent US government research report observed that the inhibiting concentration (EC50) of Ampligen® for Ebola was very low relative to the Ampligen® serum levels achievable in humans (See November 3, 2014 press release entitled Hemispherx Biopharma and United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Collaborate on Alferon® and Ampligen® Against the Ebola Virus… Initial Ebola Studies of Alferon® and Ampligen® at USAMRIID Show Protective Activity of Both Compounds at Low Concentrations http://www.hemispherx.net/content/investor/de...p?goto=805 ). Together, the three recent reports by Howard University, University of Cagliari, and USAMRIID scientists set the stage for accelerated clinical development of Ampligen® for prevention and treatment of EVD.
Our overall objectives include plans to continue seeking approval for commercialization of Ampligen® in the United States and abroad as well as to widen existing commercial therapeutic indications of Alferon® N Injection® presently approved in the United States and Argentina. In addition, we have formed collaborations with multiple research laboratories around the world to examine Ampligen®, an experimental therapeutic, and Alferon® N, an FDA-approved commercial product as potential preventatives for, and treatments of, Ebola Virus Disease.
About Alferon® N
Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age, or older. Positive results against Ebola in vitro have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Clinical trial data will be necessary to establish human efficacy of Alferon® N for Ebola virus.
About Ampligen®
Ampligen®, an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation. Ebola virus specifically inhibits the dsRNA within cells via a sequestration process. Such RNA would otherwise cause a robust antiviral response to be mounted: Ampligen may be able to overcome this deficiency in host response. Positive results against Ebola in vitro have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and other research/academic institutions. Clinical trial data will be necessary to establish human efficacy of Ampligen® for Ebola viruses.
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 especially life-threatening viruses. 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 including cancers. 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. Most newer regimens for creating apparent "cures" in chronic active hepatitis C disease require interferon as a vital component of a successful treatment regimen. 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 .
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 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 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® 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. 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.
Forward-Looking Statements
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 "intends," "plans," 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. No evidence is suggested that Alferon® N, Alferon® LDO and/or Ampligen will ever be commercially approved for the new potential treatment indications mentioned in this release.
Company/Investor Contact Charles Jones CJones & Associates Public Relations Office: 888-557-6480 Cell: 305-987-7418 Email:
