Kintara Therapeutics (NASDAQ:KTRA) Inc has announced that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has now been activated in 26 US sites as of August 16, 2021.
The GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) trial is a patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly diagnosed and recurrent GBM.
Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara's arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the US and Canada with the potential to increase that total to 65 clinical trial centers worldwide.
READ: Kintara Therapeutics reports topline results from Phase 2 clinical study of VAL-083 for recurrent GBM
"The entire Kintara team remains enthused by the pace at which our treatment arm is being activated in the study," said Kintara CEO, Saiid Zarrabian in a statement. "With 26 sites already active, including the recent addition of prestigious centers such as the Dana Farber Cancer Institute and Massachusetts General Hospital, we are delighted to witness GCAR's exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."
GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies, from different pharmaceutical partners to be evaluated simultaneously.
Kintara's VAL-083 is a "first-in-class," small-molecule bifunctional alkylating agent that crosses the blood-brain barrier.
Based on the company's internal research programs and prior sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM. Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs.
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