PRNewswire - November 2, 2000

At protocol entrance, HIV-infected asymptomatic individuals had already experienced more than an approx. 40% reduction in certain immune cells (CD4 cell level, median 585/mm3). Also, at baseline, blood HIV viral 'loads' were elevated to 4,000 copies/ml or greater (median 45,100 viral copies). The authorized protocol required that the patients not be exposed to other antiretroviral agents prior to commencement of, or during, this Phase II trial.

The two primary data 'endpoints' were HIV viral 'load', and immune cell (CD4) number in the blood. Both 'endpoints' were measured by a central reference laboratory (Lab Corp., Research Triangle, NC). Various collection intervals over 6 months were compared with baseline pretreatment values using standardized statistical programs.

As a result, the Company is presently implementing an expanded FDA authorized Ampligen(R)-based, multicenter, placebo-controlled, clinical protocol in multi-drug resistant HIV disease. First, a regimen of antiviral drugs will be selected from an approved drug panel to establish the present standard of care, called 'HAART' ("highly active antiretroviral therapy").

Then, the objective of the new protocol will be to evaluate the feasibility of enhancing the body's own immune apparatus as an adjunct to the basic 'HAART' antiviral regimen.

There are approximately 15 approved antiretroviral drugs ('HAART components') in the candidate antiretroviral drug panel. However, to the Company's knowledge, only two investigational-level, immune-based, compounds (including Ampligen(R)) are under active clinical protocol development in well-controlled tests.

Information contained in this news release other than historical information, including the referenced Phase II clinical study results, the associated laboratory results and the resultant clinical initiatives, should all be considered forward-looking and are 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.

SOURCE Hemispherx Biopharma, Inc. Web Site: http://www.hemispherx.net

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