| September 12, 2013 |
| Natural Human Interferon (α-n3) is Active Against Both Wild-type and Oseltamivir Resistant Avian-Origin Influenza A (H7N9) Virus |
… Data presented at 53rd annual meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado September 9-13, 2013
Philadelphia, PA, Thursday, September 12, 2013: Hemispherx Biopharma (NYSE MKT: HEB) announced that at the 53rd annual meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado during September 9-13, 2013, that William Mitchell, MD, Ph.D., Professor Pathology, Microbiology, and Immunology, Vanderbilt University, presented the results of a study of Hemispherx product, Alferon N Injection®, the only multi-species, natural interferon approved in the U.S. for the treatment of human refractory HPV genital warts, against wild type and oseltamivir (Tamiflu)-resistant H7N9 influenza virus.
The increasing prevalence of oseltamivir-resistant Influenza A Virus, particularly against H7N9, has been widely reported and is due in large part to the fact that just a single-step mutation in this genetically unstable virus makes it resistant to oseltamivir. Dr. Mitchell, who is member of the Board of Directors of Hemispherx, discussed new experiments on the inhibition of Tamiflu®-resistant H7N9 virus by Alferon N Injection®.
These experiments were conducted at Kansas State University by Professor Juergen 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 of Veterinary Medicine at Kansas State University and an Eminent Scholar of Kansas Bioscience Association (KBA) along with his staff.
Dr. Mitchell described the results with Alferon®, including in-vitro experiments directed against inhibiting the Tamiflu®-resistant H7N9 highly pathogenic 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 the A(H7N9) strain which demonstrates marked resistance to oseltamivir (Tamiflu®)
- 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. Alferon offers an evidence based new therapeutic strategy to mitigate the health hazards associated with the potential pandemic spread of neuraminidase inhibitor-resistant human influenza viruses.
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 US 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.
Company/Investor Contact:
Dianne Will
Hemispherx Biopharma, Inc.
518-398-6222
ir@hemispherx.net
Forward-Looking Statements and Disclosure
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.
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