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Data from Ampligen trial in chronic fatigue syndrome presented at ICAAC.
2004 DEC 2 - (NewsRx.com & NewsRx.net) -- Hemispherx Biopharma, Inc., (HEB) announced that the company presented clinical data on its pivotal randomized, double-blinded, phase III clinical trial of Ampligen versus placebo in chronic fatigue syndrome (CFS) at the 44th Annual Interscience Conference on Antimocrobial Agents and Chemotherapy (ICAAC) held in Washington, D.C., on October 30 - November 2, 2004.
New data was presented on increases in exercise capacity with Ampligen versus placebo which were correlated with an improved ability to utilize oxygen, or so called maximum oxygen consumption (VO2max).
VO2max has been previously shown to be decreased in individuals with CFS. An abnormal exercise stress test, including a low VO2max, is a laboratory result that can help qualify CFS patients for disability under Social Security Administration rules.
Additional data on subset analyses showed that both stratification cohorts (those with baseline exercise treadmill duration greater than and less than 9 minutes) improved exercise capacity substantially over 6.5%, an amount considered medically significant in other chronic diseases.
The new data, following 40 weeks of Ampligen treatment, also showed significant correlations between improvements in treadmill exercise duration and Karnofsky Performance Score (KPS) (p
In addition, subset analyses of the primary endpoint also showed that both the low (less than or equal to 9 minutes) and high (greater than 9 minutes) exercise treadmill duration strata improved by a medically significant amount with the Ampligen treatment compared to placebo.
In addition, the use of concomitant medications to treat CFS symptoms decreased in the Ampligen cohort compared to placebo by the end of the 40-week study. Over 15,000 doses of study drug were given over the course of this 40-week study.
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Source: HighBeam Research, Data from Ampligen trial in chronic fatigue syndrome presented at...