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New Study Indicates Benefits Of Ampligen in Treatment of Severe Chronic Fatigue Syndrome (CFS)

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By Source: PRNewswire • • September 13, 1999

(BRUSSELS, Belgium)Sept. 13-- Hemispherx Biopharma, Inc. today announced results of an independent evaluation of the potential pharmaco-economic benefits of Ampligen® 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® 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 grant 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®, 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® 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® 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® 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® positive response remains constant for at least 42 months following treatment initiation. Therefore, the 3.5-year annualized costs of Ampligen® and placebo groups are projected to be $13,854.70 and $30,121.58, respectively. Thus, twice-weekly infusion of Ampligen® 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.

This article also appeared in the CFIDS & FM Health Resource Email Bulletin on September 16, 1999.

Source: PRNewswire

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