Hemispherx Reports New Data on Chronic Fatigue Syndrome Treatment
PR Newswire - October 12, 1998 02:50
Presents Clinical Data at American Association for Chronic Fatigue Syndrome Research Conference
NEW YORK, Oct. 12 /PRNewswire/ -- Dr. David R. Strayer of Hemispherx Biopharma, Inc. (Amex: HEB) reported
previously unpublished findings on the most recent clinical experience with the anti-viral drug Ampligen(R) in treating patients
seriously debilitated with Chronic Fatigue Syndrome (CFS). Dr. Strayer presented the findings at the American Association for
Chronic Fatigue Syndrome Research Conference that concluded today in Boston.
Dr. Strayer reviewed the combined results of four CFS clinical trials, including three open-label studies and one
placebo-controlled study, which together encompassed over 200 individuals meeting the U.S. Centers for Disease Control's
case definition for CFS. The four clinical studies utilized similar Ampligen(R) dosage levels, duration of therapy, data endpoints
and collection intervals.
The two previously unreported sets of results were from a Hemispherx clinical trial being run in the U.S. under the cost
recovery program authorized by the U.S. Food and Drug Administration and from a trial being run in Belgium by Dr.
DeMeirleir, one of Europe's leading authorities on CFS.
While it is not appropriate under FDA guidelines for a company to make public statements about the impact of drug treatment
that occurs in any clinical trial, Hemispherx presented detailed results in a formal scientific forum and they are open to further
peer review.
At the conference, Dr. Strayer reviewed the impact that Ampligen(R) treatment had across all four studies in regards to the
patients' physical performance, cognition and quality of life. The studies employed a consistent series of outcome parameters
that have been used to study other seriously debilitating diseases and that in the case of the U.S. clinical trials were protocols
conducted under an Investigational New Drug application authorized by the U.S. Food and Drug Administration (FDA), with
approval of the relevant institutional review boards. The outcome parameters included Karnofsky Performance Scores (KPS),
exercise treadmill testing, and SCL-90-R neurocognitive function evaluation.
"We selected patients for the trials who were among the most seriously debilitated by Chronic Fatigue Syndrome," said Dr.
Strayer. "Their KPS scores were typically about 50, which means that they required considerable assistance from a caregiver
on a daily basis to perform even the most ordinary daily activities, such as cooking and cleaning."
Healthy people have KPS scores of 100. If CFS pushes patients' ability to function below 70, they typically have to drop out
of the work force.
Ampligen(R) is currently being evaluated in a Phase III clinical trial and is also available under a cost-recovery program
authorized by the FDA and administered in conjunction with Olsten Healthcare (NYSE: OLS). At the present time, there is no
fully approved treatment specifically for CFS and to the Company's knowledge, Ampligen is the only drug authorized for Phase
III clinical testing in CFS.
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.
SOURCE Hemispherx Biopharma, Inc.
/CONTACT: William A. Carter, M.D., CEO and Chairman, 215-988-0080, or
William J. Jenks, Media, 212-232-2222, or fax, 212-232-3232, or Sharon Will,
Investor Relations, 212-572-0762, or fax, 212-572-0764, all of Hemispherx
Biopharma/
/Web site: hemispherx.com |
