Kintara Therapeutics Inc (NASDAQ: KTRA) posted topline information from its phase 2, open-label clinical trial of VAL-083, its lead compound.
The company is conducting a phase 2 clinical trial of VAL-083 to treat MGMT gene patients suffering from GBM (glioblastoma multiforme) at Houston, Texas-based MD Anderson Cancer Center.
The recurrent arm of the clinical trial treated patients who are previously pre-cured using temozolomide before the recurrence of the disease.
Enrolls 85 patients
The company recruited 85 patients’ including efficacy evaluable 35 patients receiving a daily dose of 40 mg/m2 VAL-083 for the clinical study. It also includes efficacy evaluable 54 patients receiving a daily dose of 30 mg/m2 for three consecutive days of the 21-day cycle.
This 30 mg/ m2 dose relates to the recently commenced dose trial and recruiting patients for the VAL-083 study arm of the glioblastoma multiforme agile trial.
VAL-083 trial results summary
The median overall survival is eight months for the group of 48 evaluable efficacy subjects treated initially with a daily dose of 30 mg/ m2.
Consistent with the previous trial, it observed an adverse event of myelosuppression in the subjects.
A severe adverse event is noticed in patients in a cohort receiving a daily dose of 30 mg/ m2 of VAL-083.
The median overall survival rate is 7.5 months in 83 evaluable patients treated with at least one treatment cycle.
CEO of Kintara, Saiid Zarrabian, is thrilled with the recurrent arm of the study results because it provided essential efficacy and safety information to assess VAL-083 further to cure patients with GBM.
The company will continue the adaptive registration trial – GBM AGILE, where it evaluates the therapeutic agent for unmethylated MGMT, methylated MGMT, and the recurrent GBM.
The principal investigator of the clinical trial – Barbara O’Brien, said the clinical trial data support the potential of VAL-083 to cure patients with GBM.
ODD for VAL-083
VAL-083 is free from the MGMT resistance mechanism. The company already assessed VAL-083 in the U.S. National Cancer Institute-sponsored Phase 1 and 2 clinical studies. According to the clinical and pre-clinical data, the drug can treat a wide range of tumors such as blood cancer, ovarian tumors, cervical, brain, and lung cancers.
The US FDA granted ODD (Orphan Drug Designation) for VAL-083 to treat ovarian and medulloblastoma cancer. EMA and the US FDA granted ODD for VAL-083 to cure GBM.