Ampligen is still in limbo, my man

October 16, 2009, Washington Business Journal:

A decision on Hemispherx BioPharma’s new drug application for Ampligen, twice delayed by the FDA earlier this year, is still in limbo.

William A. Carter, CEO of the Center City biotech company, said last week the company is responding to issues raised by the Food and Drug Administration during its review of Ampligen, an experimental treatment for chronic fatigue syndrome.

Hemispherx has spent more than $500 million and more than three decades developing the drug.

Carter last week provided an update on the status of the FDA’s review of Ampligen to BioMedReports, a Web site that provides information on life sciences firms.

“We continue to be in contact with the [FDA] concerning certain requests they have made over the last year that have to do with toxicology,” Carter said. “This is nonclinical work on the drug. We have continued to complete reports and we expect to sometime this quarter, the fourth quarter, complete a set of requirements [from the FDA] that have to do with preclinical toxicology.”

In its latest quarterly report filed with the Securities and Exchange Commission, Hemispherx noted it is working with the Lovelace Respiratory Research Institute in Albuquerque, N.M., on animal toxic studies in support of its Ampligen application.

The August filing noted the studies were requested by the FDA and that the studies were “substantially completed,” with summary reports issued to the agency during the third quarter.

“Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010,” the company stated in the filing....

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