www.fdanews.com/articles/72591-fda-grants-sgx-orphan-drug-designation-for-troxatyl
FDA Grants SGX Orphan-Drug Designation for Troxatyl
May 23, 2005
Structural GenomiX's lead product candidate, Troxatyl, has received orphan-drug status from the FDA.
Troxatyl (troxacitabine) is a novel nucleoside analog being evaluated by the company in a Phase I/II trial for the treatment of relapsed acute myelogenous leukemia (AML) and in a Phase I/II trial for the treatment of various solid tumors. Structural GenomiX plans to complete the Phase I/II AML trial and progress Troxatyl into a Phase II trial in relapsed and/or refractory adult AML patients in mid-2005.