Company Update (NYSEMKT:HEB): Hemispherx BioPharma, Inc Announces Identification of High Responder Patient Subgroup from Ampligen® Phase III Trial in Patients with CFS/ME
Hemispherx BioPharma, Inc (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.
“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. (Original Source)
Shares of Hemispherx closed last Friday at $1.00, down $0.02 or -1.96%. HEB has a 1-year high of $2.64 and a 1-year low of $0.72. The stock’s 50-day moving average is $1.24 and its 200-day moving average is $1.50.
Hemispherx Biopharma, Inc. is a biopharmaceutical company, which engages in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based disorders. Its products include Alferon N Injection and the experimental immunotherapeutic/antiviral Ampligen. Alferon N Injection is a purified, natural source, glycosylated, multispecies alpha interferon product, composed of eight forms of high-purified alpha interferon. Ampligen includes application as a treatment for Chronic Fatigue Syndrome and as a vaccine enhancer for therapeutic and/or preventative development related to influenza and cancer treatments.