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An open label, non-randomized, multi-center, dose escalation phase I/II study of a single administration of AAV-hAQP1 to one or both parotid glands in patients with radiation-induced salivary hypofunction and xerostomia

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Trial Profile

An open label, non-randomized, multi-center, dose escalation phase I/II study of a single administration of AAV-hAQP1 to one or both parotid glands in patients with radiation-induced salivary hypofunction and xerostomia

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs AAV AQP1 (Primary)
  • Indications Xerostomia
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms AQUAx
  • Sponsors MeiraGTx

Most Recent Events

  • 13 Nov 2024 According to a MeiraGTx media release, Company recently gained alignment with the FDA on requirements for the ongoing Phase 2 AQUAx2 clinical trial for grade 2/3 radiation-induced xerostomia to be considered a pivotal trial in support of a potential BLA filing.
  • 13 Nov 2024 According to a MeiraGTx media release, data from this study were presented in an oral session at the American Academy of Oral Medicine (AAOM) 2024 annual meeting in April 2024.
  • 08 Dec 2022 According to a MeiraGTx media release, will host a conference call and webcast on December 13, 2022 to present the data from this study.

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