Hemispherx Announces Biosecurity Program to Potentially Reduce Pandemic Influenza Threat

PHILADELPHIA, Sept. 12, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) announced that at the Options for the Control of Influenza VIII Conference in Cape Town, South Africa held 5-10 September, 2013, that a scientific advisor to Hemispherx, 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), Regents Distinguished Professor at Kansas State University, and an Eminent Scholar of Kansas Bioscience Association (KBA), described his experiments in human lung cells evidencing that Alferon N Injection®, the only multi-species, natural interferon approved in the U.S. for the treatment of human refractory HPV genital warts, is biologically active, in low doses, against various classes of viruses occurring naturally in animals and humans.

The increasing prevalence of oseltamivir-resistant Influenza A viruses (IAVs), particularly H7N9, has been widely reported and is due in large part to the fact that just a single-step mutation in the neuraminidase (NA) gene of this genetically unstable virus makes it resistant to oseltamivir (Tamiflu®). Dr. Richt reported on influenza genome instability "Viral reassortment and transmission after co-infection of pigs with classical H1N1 and triple-reassortant H3N2 swine influenza viruses" in 2010 in the peer-reviewed Journal of General Virology, an international journal.

The results of the recent Kansas State University experiments, coupled with Dr. Richt's work on reassortment and other published studies, set 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.

Professor Richt's diverse experimental program, sponsored in part by the U.S. Department of Homeland Security, National Institutes of Health, European Union, U.S. Department of Agriculture, and private entities, focuses on molecular mechanisms and pathogenesis of emerging pathogens in livestock populations as a critical first step in promoting and causing human disease, including various zoonotic viruses such as highly pathogenic influenza viruses, H7N9 or H5N1(i.e. zoonotic agents).

New data regarding the genesis of pandemic flu, recently summarized by researchers at the National Institutes of Health (NIH) in "Pandemic Influenza Viruses — Hoping for the Road Not Taken", David M. Morens, M.D., Jeffery K. Taubenberger, M.D., Ph.D., and Anthony S. Fauci, M.D. N Engl J Med 2013; 368:2345-2348 June 20, 2013DOI: 10.1056/NEJMp1307009, identifies viral reassortment events occurring in animals as potential major contributors to the eventual jump into humans (cross-species transmission). Professor Richt is recognized as an expert on zoonotic agents (i.e. influenza, Prions, Rift Valley Fever, etc.) and has published extensively on the monitoring of the mutations and the basic events leading to cross-species transmission and the opportunities to adapt to its new human host with the potential to cause a pandemic.

Professor Richt 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. These initial results showed that:

  • Tamiflu® and Alferon® have a significant inhibitory effect on the wild-type A(H7N9) virus. Alferon® but not Tamiflu® had a significant inhibitory effect on oseltamivir-resistant neuraminidase mutant Shanghai 1-NA292K.
  • Alferon® is similar to oseltamivir in reduction of titers from wt A(H7N9) isolates following 48 hours exposure to each drug
  • Alferon® appears to be highly effective as an inhibitor of the A(H7N9) strain which demonstrates marked resistance to oseltamivir (Tamiflu®)
  • These results suggest new therapeutic strategies to mitigate the health hazards associated with the infection and the potential pandemic spread of neuraminidase-resistant human influenza viruses.

Tamiflu-resistant H7N9 viruses are associated with poor clinical outcomes. The potential for pandemic spread is dependent on the acquisition of additional mutations in the viral hemagglutinin gene allowing efficient human to human spread. Professor Richt's laboratory results to date suggest that Alferon® is a promising candidate to treat and control the potential for pandemic 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.

About Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), Kansas State University

CEEZAD, Center of Excellence for Emerging and Zoonotic Animal Diseases, was officially inaugurated in June 2010, with its first annual conference held in Manhattan, Kansas, home of Kansas State University. CEEZAD was formed to enhance the capability of the U.S. Department of Homeland Security (DHS) by developing "state of the art" countermeasures for high priority emerging and zoonotic animal diseases.

The College of Veterinary Medicine at Kansas State University was established in 1905. Since then more than 5,000 men and women have been granted the Doctor of Veterinary Medicine degree. Departments within the College of Veterinary Medicine are anatomy and physiology, clinical sciences, diagnostic medicine/pathobiology.

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® 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.

Competing Interests Disclosure: Dr. 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.

CONTACT: Company/Investor Contact: Dianne Will Hemispherx Biopharma, Inc. 518-398-6222 ir@hemispherx.netSource:Hemispherx Biopharma, Inc.