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Triphase secures FDA orphan drug designation for Marizomib in Malignant Glioma

MI_triphaseTORONTO and SAN DIEGO (November 19, 2015) — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for marizomib to treat patients with malignant glioma.

Malignant glioma is an aggressive form of brain cancer for which there is a significant unmet need in current treatments due to the disease’s poor prognosis. Triphase is evaluating marizomib, a novel and highly potent proteasome inhibitor, in combination with bevacizumab in patients with recurrent glioblastoma.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the United States.

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Triphase announces Health Canada approval to initiate Marizomib Phase 1 study in recurrent glioma patients

Triphase-logo-WebTORONTO and SAN DIEGO (September 25, 2015) — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced that it has received approval from Health Canada to initiate its Phase 1 clinical study of marizomib in combination with bevacizumab (Avastin®) in patients with recurrent malignant glioma in Canada. Marizomib is a novel and highly potent proteasome inhibitor that readily penetrates the blood brain barrier. It prevents the breakdown of proteins involved in signal transduction, which inhibits tumor growth.

The study will be conducted in Canada at the Princess Margaret Hospital in Toronto and led by principal investigator Warren Mason, M.D., medical director of the Brain Tumour Centre and Kirchmann Family Chair in Neuro-oncology Research at Princess Margaret Hospital.

“Malignant gliomas are rarely curable, and the prognosis for patients with high-grade gliomas is generally poor. One of the few treatment options currently available for recurrent gliomas is bevacizumab. As a result, new treatment options are urgently needed for patients suffering from this universally fatal disease,” said Dr. Mason. “Published literature indicates that targeting the proteasome in glioma cells has shown significant anti-tumor activity. Given that marizomib is a first-in-class pan-proteasome inhibitor that is brain penetrant, I am looking forward to evaluating this combination regimen in my patients.” 

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Triphase Accelerator Corporation initiates phase I study of marizomib and bevacizumab in patients with Glioblastoma

Triphase-logo-WebTORONTO and SAN DIEGO, (April 22, 2015) — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase II proof-of-concept, today 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 most common and aggressive malignant primary brain tumor.

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.

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Triphase Accelerator announces new cancer collaboration with Sunnybrook Research Institute

Triphase-logo-WebTORONTO and SAN DIEGO (Feb. 26, 2015) — Triphase Accelerator Corporation has entered into an academic center collaboration with Sunnybrook Research Institute (SRI), the research arm of Sunnybrook Health Sciences Centre, a MaRS Innovation member institution. MaRS Innovation is also a Triphase investor.

Sunnybrook Research InstituteUnder the agreement, SRI will assist in the development of Triphase’s novel, first-in-class, fully human bi-specific antibody TRPH 011 and evaluate the role of bifunctional targeting of VEGFR-2 and TIE 2 receptors in cancer. TRPH 011 binds and neutralizes VEGFR-2/KDR and TIE 2 receptors simultaneously, resulting in sustained inhibition of tumor growth and angiogenesis (the formation of new blood vessels from pre-existing vessels and a fundamental step in the transition of tumors from a benign to a malignant state).

Under the terms of the agreement, Triphase will provide funding to the laboratory of Dr. Robert S. Kerbel, senior scientist in the Biological Sciences Platform at SRI. Dr. Kerbel and his colleagues will evaluate TRPH 011 in preclinical pharmacology models. Triphase will use the findings to advance the TRPH 011 program toward an Investigational New Drug (IND) filing.

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