Hemispherx Biopharma (HEB) Announces Positive Retrospective Analysis of Ampligen Phase 3 in CFS/ME

October 31, 2016 8:35 AM EDT
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Hemispherx Biopharma (NYSE: HEB) announced that a retrospective analysis of the AMP-516 Phase III trial of Ampligen® in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), segmented primarily by disease duration, showed that 51% of Ampligen treated patients in a cohort with a disease duration of two to eight years vs. 18% of placebo patients demonstrated at least 25% improvement in placebo-adjusted exercise tolerance whereas the patient subset with less than two years or greater than eight years of disease duration failed to show a clinically-significant response. The data analysis was presented at the 12th International IACFS/ME Research and Clinical Conference: Emerging Science and Clinical Care in Fort Lauderdale, FL, October 27-30, 2016.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/7644dc0f-f193-45c5-ba6a-8a958faa3ef8.

"Our AMP-516 clinical trial demonstrated a significant result on its primary endpoint, exercise tolerance testing (ETT), using the percent of patients that demonstrated improved exercise tolerance duration of at least 25%,” said Thomas Equels, CEO of Hemispherx. “The AMP-516 clinical trial was a major component of our successful commercial approval by ANMAT in the Republic of Argentina, making Ampligen the first ever approved therapy for ME/CFS. The objective of the analysis presented at the Conference was to identify a patient subgroup that demonstrated a more robust response, and which could be recruited for a possible future clinical trial. We are pleased to have identified such a subgroup in a patient population that currently has no effective treatment options. We look forward to our discussions with the FDA and plan to finalize a confirmatory phase III clinical trial design for Ampligen in CFS/ME."

The Phase III AMP-516 clinical trial was a multi-center, double-blind, placebo-controlled study looking at the safety and efficacy of Ampligen in patients with severely debilitating CFS/ME. Ampligen or saline was administered intravenously twice weekly for up to 40 weeks. The trial demonstrated that a significantly greater percentage of Ampligen patients (39%) vs. placebo patients (23%) demonstrated an improvement of exercise tolerance of greater or equal to 25% from baseline (16% placebo-adjusted improvement; p=0.013). This retrospective subgroup analysis evaluated response rates based on disease duration: between two and eight years and less than two years or greater than eight years. The analysis showed that 51% of Ampligen patients in the high responder cohort with two to eight year disease duration vs. 18% of placebo patients improved by at least 25% in exercise duration (33% placebo-adjusted improvement, p=0.003); whereas, Ampligen patients in the other group showed no significant exercise affect vs. placebo.

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