New Study Indicates Benefits of Ampligen(R) In Treatment of Severe CFS
13.09.1999, 14:53
(Amex: HEB; HEBws) today announced results of an independent
evaluation of the potential pharmaco-economic benefits of
Ampligen(R) in treatment of severe Chronic Fatigue
Syndrome/Myalgic Encephalomyelitis (CFS/ME), including a decrease
in the number of doses of other medicines used with Ampligen(R)
and inpatient hospital treatment days.
The findings were presented at the Second World Conference on
CFS in Brussels and developed by EPI-Q, an independent company
that conducts pharmaco-economic studies under grand support.
The results of this analysis indicated a significant decrease
in the number of doses of concomitant medications required
between the treatment and control groups. The patients receiving
Ampligen(R), Hemispherx's lead compound, also demonstrated the
need for substantially fewer inpatient hospital treatment days --
101 days for the placebo group versus 15 days for the Ampligen(R)
group -- during the 24-week study period. This translated into an
annualized decrease in hospital charges of $5,806.78 for
hospitalizations alone. With the addition of concomitant
medication cost, the mean annualized health-care charges for the
treatment group were $2,097.52 versus $8,606.14 in the placebo
group.
The object of this study was to document the potential
pharmaco-economic impact of Ampligen(R) in the treatment of
CFS/ME, which frequently leads to persistent disability and
requires frequent intervention in the health-care setting as well
as long-term outpatient treatment of pain and central nervous
system symptoms. This increased utilization of health-care
services leads to significant financial burden to patients and
payers. In fact, independent reports estimate those costs to U.S.
insurance companies in excess of several billion dollars per
year.
As part of the analysis, pharmaco-economic data, including
medication use, cost and charges of hospitalizations and
emergency-room visits, were collected retrospectively during a
randomized, multi-center, double-blind, placebo- controlled trial
of 92 patients meeting the CFS/ME United States Centers for
Disease Control and Prevention definition. Subjects were
randomized to receive 24 weeks of Ampligen(R) versus placebo
administered by intravenous infusion twice weekly.
Independent data from Dr. Kenny De Meirleir et al also
presented at the Second World Conference on CFS indicate that the
duration of Ampligen(R) positive response remains constant for at
least 42 months following treatment initiation. Therefore, the
3.5-year annualized costs of Ampligen(R) and placebo groups are
projected to be $13,854.70 and $30,121.58, respectively. Thus,
twice-weekly infusion of Ampligen(R) as a treatment of CFS/ME can
reduce the utilization of health-care services and concomitant
medications resulting overall in more than 100% return on
investment for insurance carriers.
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. ots Original Text Service: Hemispherx Biopharma,
Inc. Internet: http://www.newsaktuell.de Contact: William A.
Carter, M.D., CEO & Chairman, Hemispherx Biopharma, Inc., 215-
988-0080; William Jenks, Broadgate Consultants, 212-232-2222, or
fax, 212-232-3232; Sharon Will, Investor Relations, 212-572-0762,
or fax, 212-572-0764 Web site: http://www.hemispherx.com
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