FDA Authorizes New Hemispherx Biopharma Clinical Trial of Intranasal Ampligen(R) With Seasonal Influenza Vaccine

First Clinical Application of Ampligen(R) Intranasally

Philadelphia, Pennsylvania, UNITED STATES

PHILADELPHIA, July 20, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") today announced it has received U.S. Food Drug Administration (FDA) authorization to proceed with the initiation of a new clinical trial of intranasal Ampligen® [rintatolimod; poly(I)·poly(C12,U)] used in conjunction with commercially approved seasonal influenza vaccine. The FDA authorization also requests that certain protocol amendments and pre-clinical items be filed to the Investigational New Drug (IND) Application; these requests are not expected to affect the implementation or timing of the clinical study which will involve healthy volunteers. The primary objective of this study is to evaluate the safety of three cycles of intranasal Ampligen® administered three days following each intranasal dose of seasonal influenza vaccine. Other objectives include evaluation of various immune responses to the trivalent seasonal influenza vaccine administered intranasally with and without Ampligen®. Ampligen®, a toll-like receptor 3 (TLR3) agonist, is an experimental therapeutic in advanced clinical development for the potential treatment of Chronic Fatigue Syndrome (CFS), an enigmatic disorder which may have certain viral "footprints".

The initial studies for the influenza application were conducted at the Japanese National Institutes of Health (JNIH) and resulted in a series of peer-reviewed articles in the infectious diseases medical literature over the last several years.

A similar study of Ampligen® and a seasonal influenza vaccine in mice resulted in cross-protection of the mice against a pandemic form of avian influenza (H5N1). Evidence for cross-reactivity against pandemic forms of avian H5N1 influenza virus will be investigated as one of the objectives of this study. One goal of this approach is to generate protective mucosal immunity against newly emerging strains of H5N1 with pandemic potential using Ampligen® as a mucosal adjuvant with trivalent seasonal influenza vaccine. 

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® (FDA approved for a category of sexually transmitted diseases) 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. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has 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.

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. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications.


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