Hemispherx Receives FDA Approval To Expand CFS Program – Number of Patients More Than Double in Cost-Recovery Treatment
Hemispherx Biopharma, Inc. today [April 8, 1999] said that it has received authorization from the Food and Drug Administration (FDA) to more than double the number of patients undergoing treatment in its cost-recovery program for Chronic Fatigue Syndrome (CFS).
In the first quarter, Hemispherx announced that active treatment of patients in a confirmatory Phase III clinical trial of its drug Ampligen® was underway in a 40-week protocol that involved placebo-controlled, double-blind testing.
Today’s announcement concerns the parallel clinical activity in the U.S. in which now more than 100 patients suffering from severely debilitating CFS will pay for Ampligen® to be used during the clinical program. The company said that a key part of its drug development strategy has been to use various incentives that the FDA has made available to Hemispherx, including this cost recovery program.
With the new FDA authorization, it is estimated that more than 200 patients with CFS, which is also known as Myalgic Encephalomyelitis (ME) in Europe, are involved in the combined programs. Patients are currently being evaluated in San Diego/Los Angeles/Irvine/San Francisco Bay, California; Incline Village, Nevada; Tulsa, Oklahoma; Miami/Hollywood, Florida; Chicago; Salt Lake City; Charlotte, North Carolina; Philadelphia/Delaware Valley region, Pennsylvania; Montgomery, Alabama; Washington, D.C.; New York City and three sites in the New York City/Long Island/Northern New Jersey area. These sites represent the top CFS/ME investigators in the United States.
Hemispherx, which is based in Philadelphia, also has offices in Brussels, Belgium, and antiviral drug development facilities in Rockville, Maryland. At the end of last year, Hemispherx Biopharma Europe, a subsidiary company, filed a full marketing application in Brussels and London that covers the 15-country membership in the European Union. The Company also has said that additional applications for full marketing approval in other countries are expected, based on clinical results to date.
Patients not eligible for the Phase III confirmatory trial in the U.S. may seek treatment under the expanded treatment protocol administered by Hemispherx and Olsten Health Services, a subsidiary of Olsten Corporation. Timely information can be obtained on a Hotline at 888-559-4623, managed by Olsten Health Care.
To the company’s knowledge, Hemispherx is the only company with authorized Phase III studies in the U.S. for CFS and the only company with a pending application for full marketing approval in any major pharmaceutical market world-wide. The Centers for Disease Control estimates that CFS affects approximately 500,000 Americans and various medical studies suggest a similar number of Europeans are affected as well.
Hemispherx Biopharma is a pharmaceutical company engaged in the manufacture and global clinical development of new drug entities in the nucleic acid (NA) class for chronic viral diseases and disorders of the immune system including CFS, hepatitis B and hepatitis C.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the company’s filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward-looking statements.
PR Newswire, Philadelphia, PA. April 8, 1999.