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," 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.