Kintara Therapeutics Inc (NASDAQ:KTRA) (FRA:3DM) announced Wednesday that patient recruitment is underway in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial of its drug VAL-083 for glioblastoma (GBM).
The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is an adaptive platform study designed to evaluate multiple therapies simultaneously in patients with newly diagnosed and recurrent GBM.
Val-083 is the only therapeutic agent in the trial being evaluated in all three GBM patient subtypes: newly diagnosed methylated MGMT, newly diagnosed unmethylated MGMT and recurrent.
GBM is the most deadly form of brain cancer, and this trial could shorten VAL-083 timeline to pivotal trial completion and potential regulatory submission by as much as 18 months.
Kintara is anticipating rapid enrollment, targeting 150-200 patients at 34 active and recruiting US sites. The plan is to expand to 40 sites in the first quarter of 2021, including sites in Canada and other international locations.
"The entire Kintara team is grateful and excited to participate in GCAR's groundbreaking GBM AGILE study as it offers an extraordinary opportunity to facilitate the advancement of VAL-083's clinical development in a premier GBM study," CEO Saiid Zarrabian said in a statement. "This is truly an important milestone for Kintara as we believe the study will generate important insights into the breadth of VAL-083's potential to address this deadliest form of brain cancer in all patient subtypes, while potentially bringing the program to the doorstep of commercialization."
VAL-083 is a small molecule bifunctional alkylating agent that crosses the blood-brain barrier. The drug has been granted Orphan Drug Designation for GBM by the Food and Drug Administration (FDA) and European Medicines Agency (EMA), in addition to FDA Fast Track Designation in recurrent GBM.
Additionally, VAL-083 has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA and is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer.
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