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A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy

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Trial Profile

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 24 Nov 2020

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At a glance

  • Drugs Dapatifagene navolactibac (Primary)
  • Indications Stomatitis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Oragenics Inc

    • Most Recent Events

    • 18 Jul 2020 This trial has been completed in Belgium, according to European Clinical Trials Database record.
    • 10 Jul 2020 According to an Oragenics Inc media release, due to the discontinuation of this study, the company has withdrawn the Investigational New Drug application.
    • 10 Jul 2020 According to an Oragenics Inc media release, although this study demonstrated activity in certain patient populations, the overall lack of efficacy along with other factors, inclusive of strategic product portfolio considerations, led the company to decide to discontinue further development of AG013 under the ECC.

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