Clinical Development

This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic (PK) properties of OKN-007 combined with temozolomide (TMZ) in patients with recurrent glioblastoma (GBM). All patients will have previously received the standard-of-care treatment which includes surgical resection, radiation, and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or second) established by MRI and meeting the inclusion and exclusion criteria, will be eligible for this protocol.

This is investigator initiated single arm pilot trial to assess the safety and efficacy of IV administration of OKN-007 combined with Temozolomide and adjuvant chemo-radiotherapy for adults with newly diagnosed WHO grade III or grade IV Glioblastoma Multiforme. All enrolled patients will have surgical resection of the primary lesion within 49 days before enrollment.

This is a multi-center, open label Phase 1b clinical study in recurrent malignant glioma patients to examine the safety and tolerability of OKN-007. Patients with recurrence, adequate performance status and organ function, receiving clinically appropriate doses of steroids, with a life expectancy greater than 8 weeks were eligible. OKN-007 was administered by intravenous infusion.

The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK), and efficacy of oral OKN-007 in participants with recurrent high-grade glioma.