Hemispherx Biopharma: FDA Authorizes Multi-Center, Placebo-Controlled, Double-Blind, Clinical Protocol in Multi-Drug Resistant HIV Disease

Philadelphia (ots-PRNewswire) - Hemispherx Biopharma, Inc. (Amex:
HEB; HEBws) has just received FDA authorization to conduct an advanced multi-center clinical study in drug resistant HIV. The clinical study will involve 100 patients residing in the continental United States. Candidate patients exhibit multi-drug resistance to other antivirals, which have previously received full marketing authorization and are already in general use.

The new Hemispherx protocol is designed to potentially treat multi-drug resistance, which is due to numerous HIV genomic mutations, or genetic rearrangements. The mutations eliminate the standard drug sensitive targets within the virus particle itself.

Rapid clinical results are expected because the efficacy determinations, or end points, of the clinical study are a series of well-established virus measurements. The measurement of HIV levels will be performed at an independent national reference center; clinical subjects will also have the specific viral mutations in their blood measured at the beginning and end of the protocol.

The standard of HIV care routinely involves use of "highly active anti-retroviral therapy", or HAART. HAART is usually comprised of 3 to 4 antiviral drugs selected from the approved drug list. An objective of the protocol is to evaluate a new potential mechanism of attack on the virus and also to potentially enhance the body's own intrinsic immune apparatus to ward off progressive spread of HIV.

"Rescue" or "salvage" therapy involves the addition of a potential therapeutic agent to an existing regimen of several other drugs, which may fail due to viral mutations.

Last year, according to independent surveys, HAART regimens were switched several hundred thousand times, in the United States alone, primarily due to the emergence of drug resistance and/or drug toxicity.

Recent laboratory studies by researchers at the University of California (Irvine) and University of California (Los Angeles) resulted in significant new insights with Ampligen(R), which provided the impetus for the present clinical trial authorized by the FDA. These ex vivo results were recently presented at the 13th International AIDS Conference in Durban, South Africa.

Information contained in this news release other than historical information, including the FDA approved protocol, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes 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. Accordingly, actual results may differ materially from those in any forward-looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company 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.

ots Original Text Service: Hemispherx Biopharma, Inc.
Internet: http://recherche.newsaktuell.de

William A. Carter, M.D.
CEO & Chairman of Hemispherx Biopharma, Inc.
(USA) 215-988-0080; or
Dianne Will, Investor Relations
(USA) 214-954-9300, or fax, 214-954-9333; or
Mark Kollar, Institutional Investors
(USA) 212-232-2222, or fax: 212-232-3232

Web site: http://www.hemispherx.net