Kintara Therapeutics Inc. (NASDAQ: KTRA) has announced topline data from its newly-diagnosed adjuvant arm of the open-label second phase clinical trial being carried at the MD Anderson Cancer Centre in Houston, Texas.
VAL-083 tested in GBM
VAL-083 was tested in glioblastoma multiforme patients with an unmethylated methylguanine DNA-methyltransferase (MGMT) promoter gene in a two-arm, biomarker-driven Phase 2 experiment. Topline data from the recurrent GBM arm of the trial were already announced (July 2021), providing crucial safety and efficacy data further to investigate VAL-083 as a therapeutic option for GBM.
The recently diagnosed adjuvant arm of the trial looked at GBM patients who needed adjuvant therapy following temozolomide chemoradiation. The experiment included 39 subjects (36 efficacy evaluable) who were given a 30 mg/m2/day dosage on days 1, 2, and 3 of a 21-day cycle.
The MD Anderson study’s dosage regimen (30 mg/m2/day) is similar to the trial design of the GBM AGILE study’s newly diagnosed adjuvant study arm. GBM AGILE is a groundbreaking, patient-centered, registrational, seamless Phase 2/3 adaptive platform trial testing several medicines for patients with newly diagnosed recurrent GBM.
Results affirm safety data reported in July
CEO Saiid Zarrabian said, “On behalf of the entire Kintara team, I wish to extend gratitude to MD Anderson, and all of the patients who participated in both arms of the trial. The topline results from the newly-diagnosed adjuvant arm are a particularly important milestone for the company as it further affirms the efficacy and safety data reported this past July from the recurrent arm, thus providing additional support and momentum to continue the evaluation of VAL-083 for the treatment of GBM.”
The Principal Investigator for the Phase 2 study at MD Anderson, Dr. Barbara O’Brien, added, “I continue to be impressed by the clinical data generated by both arms of the study and remain excited by VAL-083’s potential to be a game-changing therapeutic agent to help patients suffering from this deadly disease.”
