Hemispherx Analysis of New Data on Protection From Pulmonary Damage Associated With Infection by Highly Pathogenic Influenza Virus

Joint Project With Viroclinics Biosciences, Rotterdam

Ocala, Florida, UNITED STATES

PHILADELPHIA, Jan. 22, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB), today announced that Dr. William M. Mitchell of Vanderbilt University presented a research paper on January 21, 2014 at the Keystone Symposia Conference on Pathogenesis of Respiratory Viruses entitled "Protection from Pulmonary Tissue Damage Associated with Infection of Cynomolgus Macaques by Highly Pathogenic Avian Influenza Virus (H5N1) by Low Dose Natural Human IFN-α Administered to the Buccal Mucosa." This presentation is a collaborative project conducted at Viroclinics, Rotterdam, an internationally recognized research entity for the study of both seasonal and pandemic influenza viruses. The biohazard facilities are directed by Prof. Albert D.M.E. Osterhaus, an internationally known virologist specializing in the study of pandemic influenza.

The global threat of an influenza pandemic emerging from avian H5N1 and H7N9 influenza viruses that are highly pathogenic for humans has mobilized a variety of efforts to mitigate the potential devastating human and economic consequences. A key element in governmental responses has been neuraminidase inhibitor stockpiling for therapeutic or prophylactic uses although the development of viral resistance secondary to genetic changes without loss of viral fitness is a constant threat to their human deployment.

Infection of humans with H5N1 is associated with a high mortality rate (~60%) due to an alveolar destructive primary viral pneumonia frequently expressed clinically as acute respiratory distress syndrome (ARDS) (Abdel-Ghafar et al. N. Engl. J. Med. 2008; 358:261-273). Using an established non-human primate model for H5N1 infection (Kuiken T, et al. Vet Pathol. 2003;40:304-310), the collaborative team evaluated the potential for the prophylactic mitigation of the pulmonary damage characteristic of fatal cases from primary influenza virus pneumonia using a low dose oral (LDO) formulation of a commercially available parenteral natural human interferon alpha (Alferon N Injection®). The study demonstrated a dose-dependent sparing of the H5N1 induced pulmonary damage. Clinical studies will be required to validate similar results in humans from highly pathogenic H5N1, H7N9, or similar emerging avian influenza viruses.

Thus, both H5N1 influenza virus (the subject of collaboration with the Osterhaus group) and H7N9 influenza virus (the subject of ongoing collaboration with Prof. J. Richt's group at the Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), Kansas State University (please see Expert Review of Anti-infective Therapy (online edition, pages 1-5, 2014) are susceptible to Alferon N treatment in various model systems. The latter work (also conducted on Tamiflu resistant strains) was conducted at research facilities designed to enhance the capability of the US Department of Homeland Security.

Both H5N1 influenza virus and H7N9 influenza virus have recently lead to an increased incidence of clinical disease in various parts of the world.

Of special interest has been the very recent identification of the role of natural interferon in reducing the high mortality rate in H7N9 avian influenza infection by Chinese and Australian researchers who conducted clinical examinations in influenza infected Chinese patients. A higher mortality rate in the Chinese patients has been linked to a genetic defect in the interferon antiviral/immune pathways. A defect in the interferon-α induced gene product (IFITM3), which inhibits viral entry/uncoating, has been shown to correlate with higher proinflammatory cytokine levels in plasma and bronchoalvaeolar lavage samples (cytokine storm) in patients infected with H7N9. In addition, patients with this defective interferon pathway genotype have more rapid progression of their H7N9 influenza infection, development of acute respiratory distress syndrome (ARDS) and a higher mortality rate from H7N9 influenza infection compared to patients with a normal "wildtype" interferon antiviral defense mechanism (Proceedings of the National Academy of Sciences (PNAS) early edition at http://www.pnas.org/content/early/2013/12/17/1321748111).

Thus, the new study shows the importance of the interferon induced pathways in controlling influenza viral infection. No deaths were observed in individuals with the wildtype genotype, compared to a 33% mortality rate in patients with the dysfunctional interferon pathway genotype.

About Viroclinics Biosciences, BV

Viroclinics Biosciences is a leading diagnostic and clinical trial operation service company providing diagnostic and preclinical studies along with drug development for prevention and treatment of virus infections.

Its mission is to improve human and animal health by serving the biopharmaceutical industry with state-of-the-art diagnostics, operational and logistical services, custom-made models in preclinical and clinical drug testing, and expert advice on development of antivirals and vaccines. It offers a full range of virology services for new drug development programs and post-marketing surveillance of existing drugs and vaccines, ranging from traditional virology assays to the latest deep sequencing protocols for a very broad range of viruses.

Its BSL2 and BSL3 labs enable it to perform analysis according to international ISO 15189 accreditation expanded with elements of GLP and GCP. The ongoing, intimate interaction between scientists at the Erasmus MC and company staff yields a strong, flourishing platform to act and implement assays at the forefront of Viroscience.

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. 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 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. William Mitchell, Prof. of Pathology, Microbiology and Immunology at Vanderbilt University is a member of the Board of Directors of Hemispherx Biopharma, Inc. and is a shareholder in the Company. 

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