PHILADELPHIA, Sept. 12, 2013 (GLOBE NEWSWIRE) -- Chairman and CEO, William A. Carter, M.D. of Hemispherx Biopharma (NYSE MKT:HEB) announced at the Rodman and Renshaw Conference in New York City, NY on September 9, 2013, a major new initiative in the BioSecurity field involving both Alferon N Injection® and Ampligen®. Alferon N Injection® is a multi-species, natural interferon; the only natural interferon approved for sale in the U.S. Ampligen® is a dsRNA experimental therapeutic that acts as a TLR 3 activator.
Dr. Carter highlighted the broad anti-viral effect of both drugs/biologics. The Company's strategy includes plans to undertake major programs in the biosecurity field, specifically with respect to the potential prevention or treatment of pandemic flu virus, H7N9, MERS (Middle East Respiratory Syndrome) and alpha viruses such as VEE (Venezuelan Equine Encephalomyelitis). With all three classes of viruses, researchers have now confirmed significant bioactivity with Ampligen® or Alferon N Injection®, or both, in either in vitro and/or in vivo non-human studies. Alferon N Injection® has been found to be highly active against SARS virus (a close relative of MERS) by the Singapore Genome Institute in laboratory studies.
Dr. Carter highlighted the work that was recently presented at the Options for the Control of Influenza VIII Conference in Cape Town, South Africa, September, 5-10, 2013 by Professor Dr. Juergen A. Richt, DVM, Ph.D., Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD). The Cape Town presentations described the results with Alferon®, including in-vitro experiments directed against inhibiting the Tamiflu®-resistant H7N9 pandemic influenza strain. Tamiflu® (oseltamivir) and Alferon® were tested in A549 cells for antiviral activity in vitro against the wild-type (wt) human A(H7N9) isolate A/Anhui/1/2013 (wt Anhui 1) and a patient isolate (A/Shanghai/1/2013 (NA-292K; Shanghai 1-NA292K) with resistance to oseltamivir. The wt Anhui 1 was sensitive to both Tamiflu® and Alferon®. The Shanghai 1-NA292K virus was resistant to Tamiflu® treatment but was sensitive to Alferon® when tested in A549 cells.
The results of the recent Kansas State University experiments, coupled with Dr. Richt's work on reassortment and other published studies, sets the stage for evaluating the possibility that mutational changes and reassortment could be prevented in animals by the use of type I interferon and/or a type I interferon inducer. These laboratory results to date suggest that Alferon® may be a promising candidate to treat the virulent and potentially lethal Tamiflu®-resistant H7N9 virus in animals and humans. Moreover, previous research suggests that Alferon® may be active against a range of viruses existing in animal populations even in the low dose oral (LDO) formulation referred to as Alferon® LDO.
Dr. Carter highlighted the collaborations between Hemispherx and leading institutions in the BioSecurity field on both the Alferon® and Ampligen® platforms, such as U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), Kansas State University, College of Veterinary Medicine; Institute for Antiviral Research, Utah State University; Center of Biodefense and Emerging Disease, University of Texas Medical Branch; Preclinical Drug Development, Lovelace Respiratory Research Institute; Hokkaido University, Japan OIE World Reference Laboratory, Hokkaido Department of Disease Control, School of Veterinary Medicine, Research Center for Zoonosis Control; and University of Alabama Clinical Research Unit.
In April of 2012, Hemispherx announced that Ampligen®, an experimental immunotherapeutic, has been nasally administered in conjunction with FluMist® to healthy human volunteers in a study being conducted at the University of Alabama at Birmingham under the auspices of Dr. Paul Goepfert, Associate Professor of Medicine in the Division of Infectious Diseases and Director of the Alabama Vaccine Research Clinic. The objective is to determine the extent to which Ampligen® may mobilize potential protections against pandemic influenza when used in conjunction with a seasonal flu vaccine; even against mutated strains of flu virus.
Studies have now progressed at the University of Alabama (http://www.hemispherx.net/content/investor/default.asp?goto=732), and suggest that Ampligen®, given intranasally in healthy human volunteers in combination with FluMist® (a commercially available seasonal flu vaccine also given intranasally), may result in elaboration of potentially protective antibody against pandemic influenza strains.
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. Alferon is considered an experimental product with respect to any potential use against any influenza virus. 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 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 approval for Alferon N Injection® in the United States is for the treatment of refractory or recurrent external genital warts (HPV) in patients 18 years of age or older. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit http://www.hemispherx.net/.
Competing Interests Disclosure: Dr. Juergen A Richt is a compensated Scientific Adviser/Consultant for Hemispherx Biopharma, Inc., a public company, and is a shareholder in the company.
Forward-Looking Statements and Disclosure Statement
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," "expects," "may" 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 above described experimental activities and results in vitro and in animals provide no assurance that these drugs will be approved or successful as commercial products for humans or for commercial use in animals. Further, the Flu Mist® Ampligen® study at the University of Alabama is preliminary and provides no assurance Ampligen® will be approved commercially as vaccine adjuvant or for any other purpose.