Hemispherx says Ampligen shows significant improvements among fatigue patients

By Elaine Rigoli

Tampa, Fla., May 3 - Hemispherx Biopharma, Inc. said audited results of its experimental therapeutic Ampligen in a trial to treat chronic fatigue syndrome show the tests achieved improvements far above the levels considered medically significant.

The studies were conducted with Ampligen, an experimental double-stranded RNA with established broad antiviral and immunomodulatory properties that has been studied extensively in the treatment of chronic fatigue syndrome, according to a news release.

A total of five open-labeled and two double-blinded, placebo-controlled trials were done with more than 750 subjects.

The primary endpoints for these studies, treadmill performance, clearly demonstrate the results achieved, the release said.

In the recently completed phase 3 trial, patients receiving Ampligen for 40 weeks improved exercise treadmill performance by 14.8% compared with the placebo group, and 12.9% by intent-to-treat analysis.

That is twice the minimum level considered to be medically significant, which is 6.5%, the release said.

Hemispherx, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of drug entities for treatment of viral and immune-based chronic disorders.

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