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Details:
GC4419 (avasopasem manganese) is a selective dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis in patients with locally advanced head and neck cancer.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Immunology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
Avasopasem manganese is a selective dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis in patients with locally advanced head and neck cancer.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Immunology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2023
Details:
The proceedings will be used to fund pre-commercialization activities related to avasopasem manganese and advance the development of avasopasem and rucosopasem. Galera’s selective dismutase mimetic product candidate GC4419 is being developed for radiation-induced toxicities.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 15, 2023
Details:
GC4419 (avasopasem manganese) is an investigational selective dismutase mimetic drug in development as a radioprotector in combination with radiation therapy (RT), with the goal to reduce side effects from radiation therapy.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2023
Details:
Avasopasem manganese (avasopasem, or GC4419), is a selective small molecule dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2022
Details:
Avasopasem manganese (avasopasem, or GC4419) is selective small molecule dismutase mimetic in development for reduction of radiotherapy-induced SOM in patients with locally advanced HNC and for reduction of radiotherapy-induced esophagitis in patients with lung cancer.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Avasopasem manganese (GC4419) is an investigational selective dismutase mimetic drug in development as a radioprotector in combination with radiation therapy (RT), with the goal to reduce side effects from radiation therapy.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 26, 2022
Details:
Avasopasem manganese (GC4419) is a selective small molecule dismutase mimetic in development for reduction of radiation-induced severe oral mucositis in patients with locally advanced head and neck cancer and for the reduction of radiation-induced esophagitis in lung cancer.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
GC4419 (Avasopasem manganese) is a selective small-molecule dismutase mimetic in development for reduction of radiation-induced SOM in patients with locally advanced head and neck cancer and for the reduction of radiation-induced esophagitis in patients with lung cancer.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
Avasopasem manganese (GC4419) is an investigational selective dismutase mimetic drug in development as a radioprotector in combination with radiation therapy (RT), with the goal to reduce side effects from radiation therapy.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
GC4419 (Avasopasem Manganese) is a selective small molecule dismutase mimetic in development for the reduction of radiationinduced severe oral mucositis (SOM). Corrected topline Phase 3 ROMAN data demonstrate primary endpoint achieved.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2021
Details:
Avasopasem manganese (GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiationinduced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer and for the reduction of radiation-induced esophagitis.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: GC4419
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
Near double the median overall survival observed in patients receiving Galera’s dismutase mimetic + SBRT versus placebo + SBRT, showing strong therapeutic potential.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Oncology Product Name: GC4419
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2021
Details:
In the interim analysis of the intent-to-treat population, median overall survival (OS) had not been reached at the data cutoff in the GC4419 arm, compared to 38.7 weeks in the placebo arm.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Oncology Product Name: GC4419
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
Interim data on first 19 patients released in ASTRO Annual Meeting late-breaker presentation abstract showed improvement in overall survival and multiple anti-cancer efficacy measures .
Lead Product(s): Avasopasem manganese
Therapeutic Area: Oncology Product Name: GC4419
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
GC4419 is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen. The trial will enroll up to 50 hospitalized adult patients critically ill with COVID-19.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Infections and Infectious Diseases Product Name: GC4419
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
Retrospective analysis of Phase 2b trial data demonstrating the potential renal protective activity of lead candidate avasopasem manganese (GC4419), and two ongoing clinical trials evaluating avasopasem, will be presented at the ASCO 2020.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Galera to present data on adaptive dose optimization trial of stereotactic body radiation therapy with or without GC4419 (avasopasem manganese) in pancreatic cancer.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2020
Details:
Galera will present data from the two-year tumor outcomes follow up of patients with head and neck cancer treated with lead product GC4419, for severe oral mucositis in a Phase 2b clinical trial.
Lead Product(s): Avasopasem manganese
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2020
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