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Phase 1/2, Open Label, Sequential Cohort Study of a Single Intracranial Dose of AVASPA Gene Therapy for Treatment of Children With Typical Canavan Disease

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Trial Profile

Phase 1/2, Open Label, Sequential Cohort Study of a Single Intracranial Dose of AVASPA Gene Therapy for Treatment of Children With Typical Canavan Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 May 2024

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At a glance

  • Drugs RAAV-Olig001-ASPA (Primary) ; Levetiracetam; Prednisolone
  • Indications Canavan disease
  • Focus Adverse reactions; First in man
  • Sponsors Myrtelle
  • Most Recent Events

    • 07 May 2024 According to a Myrtelle Inc media release, data from this trial will be highlighted during the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting
    • 17 Apr 2024 Status changed from active, no longer recruiting to recruiting.
    • 03 Apr 2024 According to a Myrtelle Inc media release, the company announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) Designation to the Company's lead gene therapy product candidate, rAAV-Olig001-ASPA for the treatment of Canavan disease (CD).
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