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 at its first Canadian site, Sunnybrook Health Sciences Centre in Toronto.
The Kintara treatment arm is also currently actively recruiting at 30 U.S. sites as of November 24, 2021.
The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), 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.
"The Kintara treatment arm joined the GBM AGILE study in January of this year, and is already active at 31 sites in the US and Canada," stated Timothy Cloughesy, M.D., Professor of the Neurology and Molecular and Medical Pharmacology program at the University of California, Los Angeles and Principal Investigator for the GBM AGILE study. "This international clinical site, which we expect to be the first of many international sites, demonstrates the ability of GCAR's GBM AGILE platform trial to materially accelerate the clinical development timelines for the company."
"The entire Kintara team remains excited by the pace at which our treatment arm is being executed in the study," commented Robert E. Hoffman, Kintara's Chief Executive Officer. "With 31 sites already active, including our first international site, 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. 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.
ABOUT KINTARA
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for Cutaneous Metastatic Breast Cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting its GBM AGILE study to support the development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy has been previously studied in four Phase 2/3 Read More
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