On May 26, 2021 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 multiforme (GBM) has been activated in 15 U.S. sites as of May 14, 2021 (Press release, Kintara Therapeutics, MAY 26, 2021, View Source [SID1234580633]).
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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
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 can be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.
Kintara’s VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.