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Clinical Trials

Date: 2015-04-22

Type of information: Initiation of the trial

phase: 1

Announcement: initiation of the trial

Company: Triphase Accelerator (Canada - USA - CA)

Product: marizomib and bevacizumab (Avastin®)

Action mechanism:

proteasome inhibitor/monoclonal antibody.

Marizomib is a novel proteasome inhibitor that irreversibly targets and inhibits all three proteasome subunits, allowing for more durable and sustained responses. 

Bevacizumab is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor), the key driver of tumor angiogenesis.

Disease: malignant glioma

Therapeutic area: Cancer - Oncology

Country: Canada, USA

Trial details:

This Phase 1 clinical trial will evaluate a new combination of drugs, marizomib and bevacizumab (Avastin®) for the treatment of WHO Grade IV malignant glioma. The study population includes subjects who are in first or second relapse and who have not previously received any bevacizumib or other anit-angiogenic agent or proteasome inhibitor for treatment. (NCT02330562)

Latest news:

* On April 22, 2015, Triphase Accelerator Corporation announced that it has initiated a Phase I proof-of-concept clinical study of marizomib. The study is evaluating an intravenous (IV) formulation of marizomib, a novel and highly potent proteasome inhibitor, in combination with bevacizumab (Avastin®) in patients with glioblastoma. The study is recruiting and enrolling patients at the UC Irvine Health Comprehensive Brain Tumor Program at the University of California, Irvine, with Daniela Bota, M.D., Ph.D., and at The Preston Robert Tisch Brain Tumor Center at Duke University Hospital with Annick Desjardin, M.D. The open-label, multicenter, dose-escalation Phase I study is evaluating the safety and efficacy of the combination of marizomib and bevacizumab for the treatment of WHO Grade IV malignant glioma. The study population includes subjects 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 study will support the design of a larger-scale proof-of-concept study.

Triphase is conducting the study as part of a Phase I clinical development program with Celgene, with which it entered into an expanded strategic collaboration in October 2014.

Is general: Yes