Peer-Reviewed Data in Two Publications Supports the Pending NDA Application
PHILADELPHIA, March 19, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") announced the publication of a peer-reviewed article providing the results from the AMP-516 Phase III Clinical Trial of Ampligen® [rintatolimod, Poly (I) • (C12,U)], an experimental therapeutic, in the high impact, online journal, PLoS ONE. The report is entitled "A Double-Blind, Placebo-Controlled, Randomized, Clinical Trial of the TLR-3 Agonist Rintatolimod in Severe Cases of Chronic Fatigue Syndrome". Recently, researchers from the Centers for Disease Control and Prevention ("CDC") and Harvard School of Public Health published new data showing the profound economic impact of CFS on increasing healthcare costs of $452 million and decreasing CFS patient productivity by $1.2 billion in Georgia, a state with approximately 5.5 million people age 18-59 (Cost Effectiveness and Resource Allocation, 9:1, 2011).
In the current PLoS One publication, a Phase III, FDA authorized study in CFS evaluated the safety and therapeutic effectiveness of Ampligen®, an experimental therapeutic, in 234 subjects with debilitating CFS at 12 clinical sites in the United States. The Ampligen® treatment was generally well-tolerated. The article can be found at http://dx.plos.org/10.1371/journal.pone.0031334.
The primary endpoint, exercise tolerance, improved an average of 21% in subjects receiving Ampligen® compared to placebo and the proportions of patients with exercise improvements of at least 25% and 50% were 1.7 and 1.9-fold greater for the Ampligen® group versus placebo (p<0.05). An ad hoc continuous responder analysis of exercise improvement between 25% and 50% at 5% increments demonstrated a significantly greater response for patients receiving Ampligen® compared to placebo.
The Ampligen® cohort also reduced dependence on medications used to reduce symptoms of CFS compared to the placebo group (p<0.05), adding additional insight to the recent CDC/Harvard study which emphasizes the overwhelming economic burden of medical care for CFS sufferers.
In 2010, Hemispherx published new data showing that a greater proportion of placebo patients in this Phase III trial were found to have a significant prolongation of the EKG QT interval compared to patients who received Ampligen®. Prolongation of the QT interval, which is a risk factor for sudden cardiac death and arrhythmias, was associated with continued use of certain drugs by CFS sufferers known to prolong the QT interval (Journal of Applied Research, 10:3, 2010).