Orsenix is a clinical stage biotech company developing a novel oral form of arsenic trioxide (ATO) to treat acute promyelocytic leukemia (APL) and other cancers. Our investigational ATO, ORH-2014, is a patented, oral capsule that achieved the required target exposure at a dose of 15 mg once daily in a recently completed Phase 1 Study. ORH-2014 has been granted Orphan Drug Designation by both FDA and EMEA, and Orsenix gained a...
Orsenix is a clinical stage biotech company developing a novel oral form of arsenic trioxide (ATO) to treat acute promyelocytic leukemia (APL) and other cancers. Our investigational ATO, ORH-2014, is a patented, oral capsule that achieved the required target exposure at a dose of 15 mg once daily in a recently completed Phase 1 Study. ORH-2014 has been granted Orphan Drug Designation by both FDA and EMEA, and Orsenix gained alignment with the FDA to proceed with a single registrational study for accelerated approval of ORH-2014 for the treatment of newly diagnosed patients with APL, assuming favorable regulatory review.
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