Evaluating potential of Ampligen and TLR3 agonists as cancer immunotherapeutics

Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), announced today the publication of an editorial entitled "TLR3 agonists as immunotherapeutic agents," published in the March 15, 2010 edition of Immunotherapy (2010) 2(2), 137-140, co-authored by Jonathan S. Berek, MD, Chairman, Stanford University School of Medicine Department of Obstetrics and Gynecology, and Christopher F. Nicodemus, MD, Chairman and Chief Scientific Officer, Advanced Immune Therapeutics, Inc., and HEB Consultant. Drs. Berek and Nicodemus have collaborated for more than a decade seeking to identify novel strategies to mobilize immunity to treat cancer and have conducted and published numerous preclinical and clinical studies, most notably in the field of ovarian cancer. Their long standing research interests form the basis for an active collaboration with the Company to evaluate the potential for Ampligen® (rintatolimod, Poly I : Poly C12U) and TLR3 agonists as cancer immunotherapeutics.

The invited editorial highlights recent advances in the fundamental understanding of the toll like receptor pathways, notably TLR-3 and their potential as pharmaceutical targets to "mobilize immunity to eradicate microscopic and macroscopic malignancy," concluding that therapeutic improvements are now "within reach."

The authors propose that "overly robust immune responses" may be harmful and suggest that "TLR3 pathways have been distinguished from other, perhaps more toxic, TLR pathways...the safety and bioactivity of TLR-3 specific agonists can be anticipated to be unique amongst potential TLR stimulatory agents." In the editorial, Ampligen®, an experimental therapeutic, is repeatedly cited for its unique profile amongst TLR3 stimulating agents and its potential to enhance immunity targeting infection and cancer.

Pre-clinical experimentation is not necessarily indicative of clinical outcomes and the clinical use of experimental therapeutics, including Ampligen®, is subject to regulatory agency review and approval requirements.