Kintara Therapeutics Inc (NASDAQ:KTRA) (FRA:3DM) announced it has enrolled the final patient in the adjuvant arm of its ongoing Phase 2 clinical study of VAL-083 as a treatment for glioblastoma multiforme (GBM), a cancer that begins in the brain.
The adjuvant arm of the study, conducted at the MD Anderson Cancer Center in Austin, has patients receive VAL-083 in place of standard-of-care temozolomide (TMZ) following surgery and chemoradiation TMZ.
The Phase 2 trial was designed to enroll up to 36 patients to determine whether treatment with VAL-083 improves overall survival. Specifically, the trial is investigating GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene.
READ: Kintara Therapeutics says VAL-083 treatment arm in the Phase 2/3 clinical trial for glioblastoma multiforme has now been activated in 15 US sites
"Enrolling the final patient in the adjuvant arm of the Phase 2 study at MD Anderson is yet another important milestone for the company as we continue to advance VAL-083 in multiple settings, including the GCAR-sponsored GBM AGILE study, where we have already initiated patient recruitment at 15 sites as the only therapeutic agent currently being evaluated in this adaptive design registration study for all three GBM patient subtypes; newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent," CEO Saiid Zarrabian said in a statement.
VAL-083 is a small molecule bifunctional alkylating agent that crosses the blood-brain barrier. It has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the US National Cancer Institute (NCI) and has been granted Orphan Drug Designation for GBM by the US Food and Drug Administration (FDA) and the European Medicines Agency, as well as Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA.
The FDA has also granted Fast Track Designation for VAL-083 in recurrent GBM.
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