Trial Profile
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of the Effects of GC4419 on Severe Oral Mucositis in Patients Receiving Cisplatin + Intensity-modulated Radiation Therapy (IMRT) for Locally Advanced Non-Metastatic Squamous Cell Carcinoma (SCC) of the Oral Cavity/Oropharynx
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 05 Apr 2024
Price :
$35
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At a glance
- Drugs Avasopasem manganese (Primary) ; Cisplatin
- Indications Stomatitis
- Focus Registrational; Therapeutic Use
- Sponsors Galera Therapeutics
- 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.
- 31 Oct 2023 According to a Galera Therapeutics media release, the company has received official meeting minutes from the Type A meeting with FDA. The FDA reiterated that results from an additional Phase 3 trial will be required to support resubmission of the New Drug Application (NDA) for avasopasem in radiotherapy-induced SOM.