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Triphase begins Phase I trial of marizomib-bevacizumab combination to treat glioblastoma

Canada-based Triphase Accelerator has started a Phase I proof-of-concept clinical trial of marizomib, a highly potent proteasome inhibitor, for the treatment of patients with glioblastoma, the most common and aggressive malignant primary brain tumor.

The open-label, multicenter, dose-escalation Phase I trial is designed to evaluate an intravenous (IV) formulation of marizomib in combination with bevacizumab (Avastin) in these patients.

Patient enrollment is being conducted at the UC Irvine Health Comprehensive Brain Tumor Program at the University of California, Irvine, with Daniela Bota and at The Preston Robert Tisch Brain Tumor Center at Duke University Hospital with Annick Desjardin.

UC Irvine Health Comprehensive Brain Tumor Program associate professor of neurology and medical director and clinical investigator of the Phase I trial Dr Bota said: "Glioblastoma is a highly aggressive brain tumor that is innately resistant to multiple treatment modalities.

"New treatment options are urgently needed because only modest advances in treatment have occurred in the past 25 years.

"Our previous studies have shown that the proteasome pathway plays a vital role in the physiology of glioblastoma and that targeting the proteasome in glioma cells is associated with significant anti-tumor activity.

"This Phase I study with marizomib and bevacizumab should provide important information about the safety of this new combination therapy, as well as the benefit of targeting the proteasome pathway and new blood vessel formation with the anti-angiogenesis agent in patients with this uniformly fatal cancer."

The trial is evaluating the safety and efficacy of the combination of marizomib and bevacizumab for the treatment of WHO Grade IV malignant glioma.

The enrolled patients will include who are in first or second relapse and who have not previously received any bevacizumab or other anti-angiogenic agent or proteasome inhibitor.

If successful, the Phase I trial will support the design of a larger-scale proof-of-concept study.