PHILADELPHIA, July 19, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB), an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders, and Max Neeman International, one of the leading and largest clinical research organizations ("CROs") in India, jointly announce that the collaborative Phase II clinical research effort for one of Hemispherx' flagship products, Alferon N Injection® (interferon Alfa-n3) was approved by the Indian Drugs Controller General on July 13, 2010 and is expected to start enrolling patients right away.
The clinical research platform is designed to improve the quality of care for treatment of seriously ill patients hospitalized with either seasonal influenza or pandemic influenza. The CRO targeted clinical sites that will be enrolling subjects in the current monsoon season. According to various expert epidemiological sources, strains of influenza are becoming progressively resistant to currently available commercial antiviral drugs (including so-called neuraminidase inhibitors) and death rates are expected to increase globally without the development of new effective treatment strategies.
The monsoon season in India is from July through mid October, with the peak expected in August. With this in mind, a company spokesperson commented that the study was well positioned to enroll the patients necessary to complete this clinical study on a timely basis.
The Alferon N Phase II study is closely modeled on the successful clinical performance of neuraminidase inhibitors drugs, one of which was recently (yr. 2010) commercialized in Japan largely based on a single well-controlled study in hospitalized patients suffering from influenza. Unpublished pre-clinical studies, including animal studies, suggest that Alferon N may have a substantially improved protective effect on pulmonary tissue over that provided by zanamivir, a neuraminidase inhibitor. However, animal experimentation does not necessarily predict clinical outcomes.
Alferon N Injection® is an FDA approved product presently for a category of sexually-transmitted diseases. Hemispherx has invested several million dollars in improvements to the Alferon N production facility in New Brunswick, New Jersey. The goal is to increase the annual yields of Alferon N. Should the forthcoming clinical trials be successful, Hemispherx will examine application to expand the existing commercial authorization to allow Alferon N Injection® as an approved drug for treatment of hospitalized flu patients in India and elsewhere.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx' flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon LDO. Ampligen® represents experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx' platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). 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.
About Max Neeman International
Max Neeman International is one of the leading and largest CROs in India. Its specialty is that it offers services for the successful conduct of Phase I-IV clinical and device trials for small and mid-sized international and national Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies in compliance with ICH GCP standards. Operational since 2001, Max Neeman is an ISO 9001:2000 certified CRO for Monitoring, Site Management and Data Management Services. The company is presently active in 22 cities with five regional offices. Contact Donald Swankie, Vice President for more information (donald.swankie@neeman-medical.com / +1.919.424.3345). http://www.neeman-medical.com
About Max Healthcare
With 13 hospitals, 1,500 physicians and 3,000 support staff - Max Healthcare is one of a leading chain of hospitals in India. Its state of the art infrastructure, over 225 ICU beds and most advanced technologies makes it one of the best hospitals in India. http://www.maxhealthcare.in
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, change 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. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications. Further, the commencement of clinical trials in June, 2010 by Max Neeman in India is its target date but cannot be guaranteed due to a variety of risk factors outside of the parties control and should be regarded only as a forward looking estimate.