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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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MaRS Innovation featured in International Innovation magazine

International Innovation feature on MIMaRS Innovation and its member institutions are is profiled in International Innovation‘s July issue (#191) in a feature interview with Dr. Rafi Hofstein, MI’s president and CEO, written by Rosemary Peters.

The article is posted on the publication’s website and viewable through a digital interface (pages 80 and 81).

Here’s an excerpt from Dr. Hofstein’s comments:

“Canada’s academic research community is internationally highly competitive, but it has been argued that its scientific commercial success tags behind other countries such as the U.S. and the U.K. While this remains a matter of debate, I do agree that we need to continually encourage additional sources of seed capital to join is so as to allow for accelerated advancement of early-stage technologies. Industry needs to become much more engaged in advancing early-stage (and promising!) technologies emerging from the academic sector, which are usually young and in significant attention, navigation, management expertise and seed capital provisions. These are areas of rising importance in Canada, as many innovations fall into the ‘valley of death’ due to a lack of proper funding, or they leave the country and flourish in the U.S. where funding is more abundant.

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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 announces proteasome inhibitor marizomib demonstrates potent synergistic anti-multiple myeloma activity in combination with pomalidomide

Findings from Preclinical Study Presented at American Society of Hematology 2014 Annual Meeting

Triphase-logo-WebTORONTO AND SAN DIEGO (Dec. 6, 2014) — Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase II proof-of-concept clinical studies, today announced preclinical study results demonstrating that the combination of its highly differentiated proteasome inhibitor, marizomib, and pomalidomide (Pomalyst®) was synergistic in killing multiple myeloma cells.

MaRS Innovation is an early-stage investor in Triphase. See our web archive for more details.

Combined doses of marizomib and pomalidomide inhibited tumor growth and prolonged survival in disease models of this hematologic cancer. The data were presented December 6, 2014 in a poster session at the American Society of Hematology (ASH) 2014 Annual Meeting in San Francisco.

“New treatment options for patients with relapsed and refractory multiple myeloma are needed as nearly all patients will eventually relapse on currently available therapies,” said Paul G. Richardson, M.D., lead clinical investigator of the marizomib study group and director of clinical research, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute in Boston. “These preclinical results in disease models of multiple myeloma are highly promising as they demonstrate the potent activity of marizomib in combination with pomalidomide and support a clinical trial to increase response, overcome drug resistance, and improve outcomes in patients with relapsed and refractory multiple myeloma.”

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