Hemispherx Biopharma publishes Ampligen Phase III trial results

Hemispherx Biopharma has published the results in the current issue of The Journal of Applied Research in which the report is entitled ‘Cardiac Toxicity in Chronic Fatigue Syndrome (CFS): Results from a Randomised 40-Week Multicenter Double-Blind Placebo Control Trial of Rintatolimod.’

The AMP-516, Phase III FDA-authorised study in CFS evaluated the therapeutic effectiveness of Ampligen, an experimental therapeutic, and included repeated measurements of the QT interval, a component of EKG testing.

In the trial, a greater portion of the placebo patients were found to have a significant prolongation of the QT interval compared to patients who had received Ampligen twice weekly.

Reportedly, the prolonged QT interval in the placebo group was associated with continued use of certain concomitant medications, which are known to prolong the QT interval and used by CFS patients in an attempt to mitigate symptoms of the disease, while patients randomised to receive Ampligen were able to reduce their dependency on these same medications.

Hemispherx Biopharma said that the AMP-516 study was one of the studies submitted to FDA in the Ampligen NDA, which resulted in the previously-announced 25 November 2009 complete response letter, in which FDA requested that additional data be generated and submitted on effectiveness measures and potential QT interval effects.