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An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN) in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)

Trial Profile

An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN) in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 02 Aug 2019

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At a glance

  • Drugs Rintatolimod (Primary)
  • Indications Chronic fatigue syndrome; Encephalomyelitis
  • Focus Expanded access; Therapeutic Use
  • Sponsors Hemispherx Biopharma
  • Most Recent Events

    • 02 Aug 2019 According to an Hemispherx Biopharma media release, the company is preparing a manuscript based on this study for publication clearly identifying a subset with a high response rate to Ampligen.
    • 02 Jan 2019 According to a Hemispherx Biopharma media release, the company has shipped 325 recently manufactured vials of Ampligen to the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) clinical site at Incline Village, Nevada, run by Daniel Peterson, MD.
    • 19 Dec 2018 According to an Hemispherx Biopharma media release, the company do not believe that recruitment of new patients into any future studies will be impaired by additional enrollment in this treatment protocol. Expansion was possible because this year Hemispherx successfully produced two commercial-sized lots of Ampligen, which were filled and finished into approximately 16,000 vials. Both lots have passed all necessary release testing and are now available for distribution.
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