Hemispherx Biopharma Prepares Application to Initiate Phase II Clinical Trials in China with Ampligen
. . . Proposed Trial to Address Seriously Ill Patients with Influenza
Philadelphia, PA, Monday, May 17, 2010: As part of its expanding international program Hemispherx Biopharma, Inc. (NYSE Amex: HEB), (the "Company"), announced an agreement with Fountain Medical Development Ltd., a leading Chinese clinical research organization (CRO) to prepare, file and gain approval from the authorities in China to conduct a study of Ampligen, an investigational therapeutic. Ampligen® is a member of a new class of antivirals/immuno-potentiators with broad spectrum therapeutic properties. Hemispherx plans to investigate the experimental therapeutic for potential treatment of seriously ill hospitalized flu patients, many with underlying respiratory conditions. The proposed study will determine the extent to which their clinical parameters return to normal more rapidly with potential shortening of their hospital stay relative to patients treated only with placebo plus the existing "standards of care". Hemispherx has engaged Fountain with a plan to initiate this study during next year's flu season in various parts of China.
Influenza is a serious world wide health threat producing significant debilitation and death rates in individuals with compromised pulmonary functions and/or immuno-compromised conditions.
According to a recent Tufts University New Release (April 15, 2010) reporting on US flu activity across the nation, 10.5% of the 9.7 million hospitalizations in elderly patients that occurs annually were due to pneumonia and influenza. The researchers studied intensity of flu by extracting information from 248,889 Medicare and Medicaid hospitalization records from 1991 through 2004.
This agreement with Fountain Medical Group follows last month's entering a definitive contract with Max Neeman, a major India-based CRO, to conduct similar trials in India using Alferon N in severely ill patient populations.
About Fountain Medical
Fountain Medical Development Ltd. is a contract research organization (CRO) which provides a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in China. Fountain's management team has decades of combined experience working with the world's leading CRO's and drug developers and is capable of handling regulatory affairs, clinical operations, safety, project management, data management and statistical analysis, as well as global standard clinical trial protocol design. Fountain has hands-on clinical trial experience in multiple therapeutic areas in the US and China, delivering data to support submissions in the US, EU and Japan. Fountain has Phase I-IV clinical testing capabilities and central laboratory in China, which are co-localized in a leading hospital. For more information, please visit http://www.fountain-med.com.
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 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 .
Contact:
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: www.hemispherx.net
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 a 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. Similarly, the initiation or timing of clinical trials in China with Ampligen® cannot be guaranteed due to a variety of risk factors outside the Company's control.