Two New Clinical Trials to Be Initiated for Recurrent and Newly Diagnosed Malignant Gliomas
TORONTO and SAN DIEGO, [May 3, 2016] — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced that it is expanding its current collaboration with Celgene Corp. in the development of marizomib for the potential treatment of malignant gliomas.
The two companies will collaborate on a Phase 2 study using marizomib (MRZ) as monotherapy in recurrent glioblastoma, as well as a Phase 1b trial of MRZ in combination with temozolomide (Temodar®) and radiation in newly diagnosed, Grade 4 malignant glioma.
“We have been encouraged by our Phase 1 results of marizomib and bevacizumab in recurrent glioma, and as a result we believe there is tremendous potential for marizomib both as monotherapy and in combination with other treatments, including temozolomide and radiation,” said Mohit Trikha, Ph.D., chief scientific officer and head of Triphase Accelerator R&D. “Our partnership with Celgene has been valuable in ensuring these trials continue, and we look forward to our continued collaboration to explore the tremendous potential of marizomib.”
The monotherapy study will investigate the safety and efficacy of MRZ in recurrent glioma patients administered as a 10-minute infusion on days 1, 8 and 15 over a 28 day cycle. The trial will determine activity of MRZ as a single agent, as well as safety, progression-free survival and overall survival. Another study will be initiated shortly in combination with temozolomide and radiation in newly diagnosed Grade 4 malignant glioma.
Marizomib is a novel, irreversible, potent and brain-penetrant proteasome inhibitor, which inhibits all three proteasome subunits, thus providing superior potency, specificity, and duration of proteasome inhibition, and potentially improved clinical activity.
Triphase Accelerator is developing marizomib in both intravenous (IV) and oral formulations as a potential best-in-class proteasome inhibitor for hematologic malignancies and solid tumors. The IV formulation has been evaluated in more than 300 patients in multiple clinical studies in patients with solid and hematologic malignancies, either as a single agent or in combination with dexamethasone, a histone deacetylase inhibitor, or an immunomodulatory drug.
The company is currently evaluating marizomib in a proof-of-concept clinical study in combination with bevacizumab (Avastin®) in patients with Grade IV malignant glioma (glioblastoma), and has received Orphan Drug designation for marizomib in glioblastoma in the United States from the FDA. In addition, Triphase Accelerator is currently developing marizomib in combination with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma, and has received Orphan Drug designation for marizomib in multiple myeloma in the United States and the European Union. Triphase Accelerator is also evaluating an oral formulation in preclinical studies.
About Triphase Accelerator
Triphase Accelerator is a private drug development company with a primary focus on oncology and with operations in Toronto and San Diego. Triphase Accelerator is dedicated to advancing novel compounds through Phase 2 proof-of-concept clinical studies using a unique, science-based, high-quality model that is faster and more cost-effective than traditional pharmaceutical and biotech industry drug development approaches. Triphase Accelerator was spun out of the Ontario Institute for Cancer Research (OICR), with support from the Fight Against Cancer Innovation Trust (FACIT), MaRS Innovation and MaRS. It has a strategic relationship with Celgene for marizomib. For more information, visit www.triphaseco.com or LinkedIn.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com.
Mohit Trikha, Ph.D., Chief Scientific Officer
Triphase Accelerator Corporation
JQA Partners, Inc.
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