Triphase Receives FDA Orphan Drug Designation for Marizomib in Multiple Myeloma
-- Company Presenting Today at Biocom’s Global Life Science Partnering Conference --
TORONTO & SAN DIEGO--(BUSINESS WIRE)--Triphase Accelerator Corporation today announced that marizomib, its novel, potent proteasome inhibitor, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA)'s Office of Orphan Products Development for the treatment of multiple myeloma. The orphan drug designation will provide Triphase with 7-year marketing exclusivity for marizomib and other benefits upon FDA approval.
“We are pleased that the FDA has granted orphan drug designation for the development of marizomib to benefit patients with multiple myeloma”
“We are pleased that the FDA has granted orphan drug designation for the development of marizomib to benefit patients with multiple myeloma,” said Frank Stonebanks, founder, president and CEO of Triphase. “While patients with refractory multiple myeloma are living longer and better lives as a result of medical innovation, there is still a need for new treatment options. We are excited to move forward with the development of marizomib, a potential best-in-class agent, and hope to advance the treatment paradigm that will turn this once acute disease into a long-term manageable disease.”
Mr. Stonebanks will be presenting at Biocom’s fourth annual Global Life Science Partnering Conference today at 11 a.m. PST at The Lodge at Torrey Pines in La Jolla, Calif. During his presentation, he will provide an update on the clinical development status of marizomib, including the new orphan drug designation.
Marizomib is a novel, highly potent proteasome inhibitor that is being evaluated for the treatment of multiple myeloma and other cancer indications. An intravenous (IV) formulation has been evaluated in more than 230 patients across four Phase I/II studies, either as a single agent or in combination with dexamethasone or an HDAC inhibitor. Triphase is currently evaluating the IV formulation in an ongoing Phase II clinical trial in combination with dexamethasone in a highly refractory multiple myeloma population, including those refractory to carfilzomib; it is also being tested in a Phase I/II study in combination with pomalidomide and dexamethasone in relapsed and refractory multiple myeloma. Triphase is also developing an oral formulation of marizomib that is currently in IND-enabling studies.
Triphase is a private, oncology- focused accelerator dedicated to advancing compelling, well differentiated drugs through human proof of concept (Phase II) faster and more efficiently than the pharmaceutical and biotech industry. Triphase has unique strategic relationships with Celgene and the Ontario Institute for Cancer Research (OICR). The company is leveraging the innovation ecosystems in Toronto and San Diego to rapidly advance investigational products from IND to Phase II. For more information, visit www.triphaseco.com.