On May 27, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM), titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE), has activated its first European site, University Hospital Zurich in Zurich, Switzerland (Press release, Kintara Therapeutics, MAY 27, 2022, View Source [SID1234615199]).
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GBM AGILE is currently active at 44 clinical sites in the United States and Canada as of May 26, 2022.
GBM AGILE is a patient-centered, Phase 2/3 adaptive platform trial 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 U.S. and Canada with potential to increase this total to 65 clinical trial centers worldwide.
"This first European clinical site for the Kintara treatment arm of the GBM AGILE study joins 44 active sites in the U.S. and Canada," stated Timothy Cloughesy, M.D., Global Principal Investigator for the GBM AGILE study and Professor of the Neurology and Molecular and Medical Pharmacology program at the University of California, Los Angeles. "We are pleased with the reception we are receiving internationally, and this milestone provides us with continued confidence in the ability of GCAR’s GBM AGILE platform trial to materially accelerate the clinical development timelines for companies."
"We continue to see an accelerated pace for which our treatment arm is being executed in the study," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "We are also observing GCAR’s exceptional clinical trial execution capabilities, which were among the aspects that drew us to participate in this highly efficient registrational study. This achievement provides continued excitement as this study progresses."
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. With its innovative design and efficient operational infrastructure, data from GBM AGILE may be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.