Center for Special Immunology -CSI- to Begin a New Study Involving Immune-Based Therapy Together With Strategic Therapeutic Interruptions -STI's- for Patients Living With HIV-Infection.

Business/Medical Editors

FOUNTAIN VALLEY, Calif.--(BW HealthWire)--June 7, 2001

The Orange County Center for Special Immunology (CSI) announced today that it will begin a research trial involving a new approach to treating human immunedeficiency virus (HIV) infection.

The study will involve using immune-based therapy with the medication Ampligen(R) in combination with strategic therapeutic interruptions (STI's) of antiviral medications. The research protocol is entitled: The Role of Ampligen in Strategic Therapeutic Interruptions (STI's) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.

"We are delighted to have been selected as one of only 10 anticipated research sites in the country recruiting patients for this important study," said Paul J. Cimoch, MD, Director of CSI. "This protocol combines two new possible strategies for the treatment of HIV-infection. First, we will be studying the effects of thee immuno-modulating drug Ampligen. Second, we will be combining this immuno-modulator with antiviral treatment interruptions in a unique approach to treating HIV-infection," Dr. Cimoch added.

Ampligen is a double-stranded RNA molecule known to stimulate various components of the immune response. It has previously been studied in HIV-infected patients. The concept of STI's was introduced in the past few years as a possible means of stimulating the immune response and potentially allowing less time on HAART therapy, hopefully diminishing the associated side effects and toxicities.

The protocol design is an open label yet prospective, randomized, controlled study of the safety and biological effects of adding Ampligen to an STI protocol of HAART. All patients will have been on a HAART regimen that has suppressed HIV viral load below the limits of detection for at least 9 months or longer. The study participants will then be randomized to Ampligen or no Ampligen. After 8 weeks, HAART will be discontinued and patients will be monitored weekly for HIV viral load rebound. Following any HIV viral load rebound, HAART will again be restarted. Again, 8 weeks after the plasma HIV RNA viral load becomes undetectable, a second STI will be introduced and monitored identically to the initial STI. This sequence will be repeated for the full 64-week trail period. Thus, each subject in both arms of the trial will establish their own HAART-free time intervals during the sequential STI's. The primary objective of the trial is to evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV viral load rebound during the STI of HAART.

A Company spokesperson said that Hemispherx Biopharma, Inc. (AMEX: HEB; HEBws) was "looking forward to working with the Center for Special Immunology (CSI), which has already been playing an important role in the Company's other major clinical trials arena, Chronic Fatigue Syndrome."

Operating in Orange County since 1990, the Center for Special Immunology (CSI) provides holistic primary medical care and clinical research exclusively for patients suffering from immune system disorders. Hemispherx is a globally-operating biopharmaceutical company engaged in the manufacture and worldwide clinical development of new drug entities in the nucleic acid (NA) class for viral diseases and disorders of the immune system designed to mitigate the skyrocketing costs of Iong-term medical care for the chronically ill.

Information contained in this news release other than historical information, should all 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 re/ease and in the Company's filing 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.