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Kintara Therapeutics Inc (NASDAQ: KTRA) has announced that the VAL-083 treatment arm in the Global Coalition for Adaptive Research registrational Phase 2/3 trial for glioblastoma multiforme (GBM) has been activated.
The trial, titled GBM AGILE, is a patient-centered, adaptive platform trial for registration evaluating multiple therapies for newly diagnosed and recurrent GBM.
The trial plans to enroll 150-200 patients in the Kintara arm of the study at 30 sites in the U.S. and Canada, potentially increasing this total to 40 clinical trial centers.
In GBM AGILE, VAL-083 is the only therapeutic agent currently being evaluated in all three GBM patient subtypes.
It may accelerate VAL-083's time to pivotal trial completion and potential regulatory submission by up to 18 months.
It provides a cost-effective opportunity to advance VAL-083 due to the GBM AGILE study's expense-sharing protocol.
Kintara's VAL-083 is a "first-in-class," small-molecule bifunctional alkylating agent that crosses the blood-brain barrier.
Price Action: KTRA shares are 13.5% at $1.68 during the market session on the last check Wednesday.
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