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Fase 3-trials tonen aan:



leidt tot

aanzienlijke verbetering

van de inspanningscapaciteit.






Ampligen zal op de komende konferentie van de HHV-Foundation de (tussentijdse) resultaten van de fase 3-studies presenteren: circa 15% verbetering, onder meer bepaald aan de hand van de inspanningskapaciteit: de prestaties op de loopband.


Eigenlijk is al 15 jaar bekend dat Ampligen (antiviraal middel en immuunmodulator) voor een grote groep CVS-patiŽnten een effektief geneesmiddel is. Vraag dat maar aan de mensen die begin jaren 90 !! aan de Ampligen-proefstudie mochten deelnemen.




Het belangrijkste gedeelte van het persbericht:


Hemispherx Biopharma to Present Audited Results of Ampligen Clinical Trials on Chronic Fatigue Syndrome at 5th International Conference on HHV:


Studies Show Medically Significant Improvements Among CFS Patients


Business Wire, 3 mei 2006


Hemispherx Biopharma Inc. will today present the audited results of the Company's experimental therapeutic Ampligen clinical trials in Chronic Fatigue Syndrome at the 5th International Conference on HHV-6&7 in Barcelona, Spain. The presentation shows that the tests achieved improvements far above the levels considered medically significant.


The studies, presented by Dr. William Mitchell Director, Professor at Vanderbilt University and member of the Board with Hemispherx Biopharma, were conducted with Ampligen, an experimental double-stranded RNA, dsRNA, with established broad antiviral and immunomodulatory properties, that has been studied extensively in the treatment of Chronic Fatigue Syndrome (CFS). A total of five open-labeled and two double-blinded, placebo-controlled trials were done with over 750 subjects.




The primary endpoints for these studies, treadmill performance, clearly demonstrate the results achieved. In the recently completed Phase III trial, patients receiving Ampligen for 40 weeks improved exercise treadmill performance by 14.8% compared to the placebo group, and 12.9% by intent to treat analysis. That's twice the minimum level considered to be medically significant, which is 6.5%.


Ampligen treatment in chronically debilitated CFS populations has demonstrated levels of improvements in both physical well-being and quality of life that can be linked with dysregulation of gene expression associated with energy metabolism. The improvements in exercise duration are significantly correlated to improvements in oxygen utilization and physical performance.




The 5th International Conference on HHV is sponsored by the HHV (human herpes virus) 6 Foundation, a non-profit entity formed to foster basic and clinical research into HHV-6 and its diseases. The research of Hemispherx is highlighted under this year's focus on antivirals and immunomodulatory treatments.