11/26/2012 2:49 AM ET
In less than a month, Hemispherx Biopharma Inc. will face an FDA advisory
panel that will review its lead compound Ampligen for the proposed
treatment of chronic fatigue syndrome or CFS.
Ampligen, co-invented by Hemispherx's CEO William Carter, has been under
development since the 1970s.
The new drug application for Ampligen as a treatment for chronic fatigue
syndrome was filed by the company in October 2007 based on results from
four well-controlled trials with over 1,200 trial subjects and 90,000
doses. But the NDA was deemed to be insufficient to permit a review and was
sent back to the drawing board.
Addressing all the questions posed by the FDA concerning the Ampligen NDA,
the company filed its response in January of 2008. Convinced by the
company's reply, in July 2008, the regulatory agency accepted for review
the new drug application for Ampligen to treat CFS and was expected to
announce its decision by February 25, 2009.
Seeking additional time for a full review of the submission, the FDA
postponed the decision date by 3 months to May 25, 2009. However, the
decision was again deferred, and a complete response letter for Ampligen
NDA was issued in November 2009, requesting additional confirmatory phase
III study to support its approval.
Supported by supplemental clinical data analyses, in August of this year,
Hemispherx submitted its response to the Complete Response Letter for
Ampligen NDA. The resubmitted NDA has a decision date set for February 2,
Before the FDA makes its final decision, the Ampligen NDA is scheduled to
be reviewed by an FDA panel of outside experts on December 20, 2012.
Chronic fatigue syndrome is a condition in which patients have persistent
or relapsing fatigue. There is neither a known cause, nor an effective
treatment for CFS.
Besides CFS, Ampligen has also been tested in clinical trials as a
potential treatment of Hepatitis B, HIV and various cancers, earning it the
sobriquet "a drug in search of a disease. Carter also had plans to treat
tobacco with Ampligen and create a "healthy" cigarette.
The company has one FDA-approved product Alferon N Injection for refractory
or recurring genital warts. Commercial sales of Alferon N Injection were
halted in March 2008 when the company's finished goods inventory expired.
In a recent SEC filing the company has revealed that the production of new
Alferon drug product inventory will not commence until the capital
improvements and related validation phases at its New Brunswick
manufacturing facility are complete.
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