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Hemispherx's Ampligen Rehash Unlikely to Impress FDA

Stocks in this article: HEB

Depending on which data presentation you believe, the Ampligen study was either a success or a failure. By rejecting Ampligen in 2009, FDA clearly sided with the latter view.

In March, Hemispherx published the full data from the Ampligen trial in the open-access science journal PLOS One. Once again, the study results changed and got worse.

Ampligen-treated patients with chronic fatigue syndrome entered the study with a mean, baseline treadmill exercise duration of 576 seconds. After 40 weeks of treatment, mean exercise duration rose to 672 seconds, or a 16.7% improvement.

The placebo patients began the study with a mean, baseline treadmill exercise duration of 588 seconds and ended at 616 seconds, or an improvement of 4.8%.

That works out to a placebo-adjusted improvement in exercise duration for Ampligen of 11.9%. This benefit doesn't appear to be statistically significant, however. The study, as published in PLOS One, makes no mention of this intra-group comparison reaching statistical significance.

The Ampligen study appears to have failed -- which gibes with the FDA's decision to reject the drug and call for a new study to be conducted.

Hemispherx has not invested the money and time necessary to run a new Ampligen study, choosing instead to change the way the primary endpoint of treadmill exercise duration was measured. Instead of comparing the two groups of Ampligen and placebo patients, Hemispherx switched to analyzing the exercise data using each individual patient as their own comparator.

On this "intra-patient" basis, Ampligen improved exercise duration by 36.5% compared to a 15.2% improvement for placebo patients. The net difference of 21.3% was "statistically significant" with a p value of 0.047, according to the PLOS One study. Hemispherx CEO William Carter and Medical Director David Strayer were lead authors of the study. William Mitchell, a Hemispherx director, is also listed as a study author.

Hemispherx also conducted other, post-hoc analyses claiming to show that patients who were able to exercise longer following Ampligen therapy had improved quality of life and reduced dependency on concomitant medications compared to Ampligen patients who couldn't exercise longer.

All of these new analyses of the Ampligen data were done retrospectively, or long after the study was completed. Hemispherx has made no effort to confirm any of these findings with new clinical trials.

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