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ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer

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Trial Profile

ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2024

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At a glance

  • Drugs Avasopasem manganese (Primary)
  • Indications Stomatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ROMAN
  • Sponsors Galera Therapeutics

    • Most Recent Events

    • 28 Mar 2024 According to a Galera Therapeutics media release, General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022. The decrease was primarily attributable to lower personnel-related expenses due to the Workforce Reduction and the halting of avasopasem commercial preparation efforts following the receipt of the CRL from the FDA for the avasopasem NDA for radiotherapy-induced SOM in August 2023.
    • 28 Mar 2024 According to a Galera Therapeutics media release, in February 2023, company announced that the U.S. Food and Drug Administration (FDA) accepted for filing and granted priority review to the New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced SOM in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
    • 14 Nov 2023 According to a Galera Therapeutics media release, In November 2023, the cisplatin-related CKD data from this trial was presented at the American Society of Nephrology (ASN) Kidney Week 2023 meeting, which took place November 2-5 in Philadelphia, PA.
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