Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today 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 been activated in 15 U.S. sites as of May 14, 2021.
The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), 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 30 sites in the U.S. and Canada with potential to increase this total to 40 clinical trial centers.
"The entire Kintara team is enthused by the pace at which our treatment arm is being activated in the study," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "With 15 sites already active, including prestigious centers such as Memorial Sloan Kettering, Henry Ford Cancer Institute, Columbia University Irving Cancer Research Center, Emory University Winship Cancer Institute, and the University of Florida, 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."
Key GBM AGILE Highlights for VAL-083
Only therapeutic agent currently being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT; newly-diagnosed unmethylated MGMT; and recurrent
May accelerate VAL-083's time to pivotal trial completion and potential regulatory submission by up to 18 months
Cost-effective opportunity to advance VAL-083 due to the GBM AGILE study's expense sharing protocol
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