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A Double Blind, Prospective, Randomized, Placebo Controlled, Multi-center Phase 3 Study to Evaluate Efficacy and Safety of Cevira in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)

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A Double Blind, Prospective, Randomized, Placebo Controlled, Multi-center Phase 3 Study to Evaluate Efficacy and Safety of Cevira in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2024

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At a glance

  • Drugs Hexyl aminolevulinate (Primary) ; Hexyl aminolevulinate (Primary)
  • Indications Cervical intraepithelial neoplasia; Human papillomavirus infections; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms APRICITY
  • Sponsors Asieris Pharmaceuticals

    • Most Recent Events

    • 17 Sep 2024 According to an Asieris Pharmaceuticals media release, company announces that its partner Asieris Pharmaceuticals have been accepted for oral presentation of this study by the International Photodynamic Therapy & Photodiagnosis Update Conference in Germany on September 17, 2024. focusing on the efficacy data related to the regression of the histological grade of cervical precancerous lesions.
    • 17 Sep 2024 Results presented in the Asieris Pharmaceuticals Media Release.
    • 17 Apr 2024 According to an Asieris Pharmaceuticals media release, the company plans to facilitate localized production and initiate development of a second-generation product for APL-1702. It also intends to submit a pre-NDA communication application to the European Medicines Agency (EMA) in the third quarter of 2024. Additionally, the company expects to be in discussions with the US FDA in second half of 2024 to align with the agency on the registration requirements in the US.

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