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Friday, October 16, 2009
Hemispherx drug for chronic fatigue held up by additional FDA demands
Philadelphia Business Journal - by John George Staff Writer
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.
Carter told BioMedReports the FDA has also "done a number of audits" of the
company's clinical sites and manufacturing facility during the past 12
months.
"The clinical inspections resulted in no findings that required [major]
corrective action by the company," he said, adding that the agency did note
compliance issues at its facility in New Brunswick and at a contract
facility in Spokane, Wash.
The manufacturing plant in Spokane is where Ampligen is packaged.
Carter said over this past summer the company addressed the FDA's compliance
issues at its New Jersey facility and submitted a report to the agency for
review. He said the company expects to complete remediation efforts at the
Spokane facility within the next several weeks.
"Until all those reports are completed and filed, the agency can withhold a
final decision on the commercialization of the product," said Carter.
Earlier this week, the company announced the discovery of a novel retrovirus
in chronic fatigue syndrome patients.
A study published in the Oct. 8 issue of Science Express by a consortium of
researchers found a new retrovirus in the blood cells of 67 percent of
chronic fatigue syndrome patients and in 3.7 percent of healthy control
subjects.
Hemispherx is collaborating with the Whittemore Peterson Institute, in Reno,
Nev., to evaluate the potential role of Ampligen in the clinical treatment
of chronic fatigue syndrome patients who have a specific immune deficiency
in cell activity.
The company plans to provide an update on its programs targeting the
disorder at a November Health and Human Services Chronic Fatigue Syndrome
Advisory Committee meeting in Washington, D.C.
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