BETHESDA, Md., Sept. 8, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) will present new clinical data on the possible inter-relationships of XMRV positivity/chronic fatigue syndrome/Ampligen® responsiveness at the 1st International Workshop on XMRV being held at the National Institutes of Health in Bethesda, MD, on September 7 and 8, 2010.
CFS is a severe disorder consisting of profound fatigue and a variety of other debilitating symptoms that affects up to 4 million Americans. Recently, DNA was identified from a human gamma retrovirus (XMRV) in 67% of CFS subjects. Evidence also suggested that approximately 50% of the CFS subjects mounted a specific antibody response against XMRV (Science 326, 585-589 (2009)). The objective of this study was to compare demographic parameters and health/performance status of XMRV antibody positive vs. negative CFS subjects enrolled in a Phase III clinical trial evaluating the safety and efficacy of a toll-like receptor 3 agonist, rintatolimod (PolyI:PolyC12U, Ampligen®). The response to Ampligen® with regard to the primary endpoint, treadmill exercise tolerance testing (ETT), in this population was also evaluated.
Two-hundred-eight (208) evaluable subjects, who met the original (1988) and revised (1994) Centers for Disease Control criteria for CFS, participated in this randomized, placebo-controlled, double-blinded, multicenter study. Only severely debilitated patients with a Karnofsky Performance Scale between 40-60 were selected for this study. The primary endpoint was exercise treadmill duration. Subjects received Ampligen® (200-400 mg) or an equivalent volume of placebo (saline) twice weekly by intravenous infusion for 40 weeks. Baseline (or earliest available specimen) serum samples from all 208 subjects were analyzed for antibodies directed against XMRV.
The XMRV antibody positive cohort had a greater relative percentage of subjects showing a >25% increase in ETT with Ampligen® treatment compared to placebo than the XMRV antibody negative cohort. The results also suggest that the XMRV antibody negative subjects with CFS have a lower activity level and a reduced ability to complete normal daily activities at baseline. If validated as a relevant basis for targeting the XMRV positive CFS patient sub-population, the observed response advantage of the XMRV may translate into needing a smaller sample size for future research using a placebo-controlled parallel design to obtain 80% power (α=0.05): 216 XMRV antibody positive subjects vs. 330 XMRV antibody negative subjects. Additional studies to further evaluate XMRV in this CFS population are currently underway.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the 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® represents experimental nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of 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 more information, please visit http://www.hemispherx.net/">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.