TORONTO 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.
“The orphan drug designation granted by the FDA recognizes the unique potential of marizomib to benefit patients with malignant glioma, for whom current therapies provide minimal benefit,” said Mohit Trikha, Ph.D., Triphase’s chief scientific officer and head of R&D. “Our Triphase Accelerator model enables faster and more efficient drug development than traditional approaches, due to our extensive clinical and regulatory experience in developing marizomib and our relationships with key investigators and leading institutions. Building on our experience and working with urgency and dedication, Triphase Accelerator rapidly advances novel compounds through Phase 2 proof-of-concept in key areas of high patient need, such as malignant glioma.”
An orphan drug designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance, and waiver of Prescription Drug User Fee Act (PDUFA) filing fees. The OOPD also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.
About Triphase Accelerator
Triphase Accelerator, a private drug development company focusing on oncology and with operations in Toronto and San Diego, is 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 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 Discovery District. It has a strategic relationship with Celgene for marizomib.