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A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

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Trial Profile

A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2024

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At a glance

  • Drugs Zopapogene imadenovec (Primary)
  • Indications Recurrent respiratory papillomatosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors PGEN Therapeutics; Precigen Inc

    • Most Recent Events

    • 30 Dec 2025 According to a Precigen Inc media release, company completes the submission for BLA to FDA for PRGN-2012 treating in patients with RRP. The submission is in initial 60 day review, during which time the FDA will decide whether to accept the BLA for further review and set PDUFA action date. The BLA included a request for priority review, which, if granted, would reduce the review timeline from the standard 10 month to a priority 6 month review from the date the submission accepted by the FDA.
    • 08 Nov 2024 Planned End Date changed from 2 Jun 2026 to 5 Jun 2026.
    • 04 Jun 2024 Results evaluating the safety and efficacy of PRGN-2012 in patients with RRP requiring a minimum of 3 surgeries in the 12 months prior to treatment were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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