Structural GenomiX, Inc. (SGX) recently announced that it has been granted Orphan Drug Designation from the FDA for its lead product candidate, Troxatyl (troxacitabine), for the treatment of acute myelogenous leukemia (AML).
Troxatyl™ is a novel nucleoside analog that is currently being evaluated by the company in a Phase 1/2 trial for the treatment of relapsed AML and in a Phase 1/2 trial for the treatment of various solid tumors. The company plans to complete the Phase 1/2 AML trial and progress Troxatyl™ into a Phase 2 trial in relapsed and/or refractory adult AML patients in mid 2005.
Orphan Drug Designation provides the sponsor of an orphan drug product with eligibility for: seven year marketing exclusivity following marketing approval; tax credits for clinical research; reduced NDA filing fees; grants for further clinical research and development; and assistance with the review of clinical trials protocols.
