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A pivotal study of Brilacidin for Oral Mucositis

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Trial Profile

A pivotal study of Brilacidin for Oral Mucositis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2019

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At a glance

  • Drugs Brilacidin (Primary)
  • Indications Stomatitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Innovation Pharmaceuticals

    • Most Recent Events

    • 28 Mar 2019 According to an Innovation Pharmaceuticals media release, the European Medicines Agency (EMA) has granted a meeting with the Company's European subsidiary, IPIX Pharma Ltd., to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
    • 15 Mar 2019 According to an Innovation Pharmaceuticals media release, the company has completed the necessary documentation to the European Medicines Agency (EMA), requesting Scientific Advice to advance Brilacidin oral rinse in a Phase 3 program for the prevention of severe Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
    • 02 Jan 2019 According to an Innovation Pharmaceuticals media release, the company expects to initiate this study in 2019.

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