Kintara Announces Initiation of Patient Recruitment for VAL-083's Study Arm in the GBM AGILE Trial
January 13, 2021 at 01:00 pm
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Kintara Therapeutics, Inc. announced that patient recruitment has commenced in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM). The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a revolutionary, patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma 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.
Kintara Therapeutics, Inc. is a biopharmaceutical company focused on the development of new solid tumor cancer therapies. The Company's lead program is REM-001 Therapy for cutaneous metastatic breast cancer (CMBC). REM-001, is a late-stage photodynamic therapy (PDT). PDT is a treatment that uses light sensitive compounds, or photosensitizers, that, when exposed to specific wavelengths of light, act as a catalyst to produce a form of reactive oxygen that induces local tumor cell death. It has a proprietary, late-stage photodynamic therapy platform. REM-001 Therapy consists of the laser light source, the light delivery device, and the REM-001 drug product. Its product candidate, VAL-083, is a DNA-targeting agent intended to treat drug-resistant solid tumors, such as glioblastoma (GBM) and potentially other smaller tumors, from the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study. VAL-083 is also used for various other indications.
KINTARA THERAPEUTICS, INC. 
