ChemGenex targets NDA for OMAPRO

Melbourne-based ChemGenex Pharmaceuticals has hurdled another... hurdle in the process to bring its anti-chronic myeloid leukaemia (CML) drug, omacetaxine mepesuccinate, branded as OMAPRO, to market by completing its new drug application (NDA) submission for the US Food & Drug Administration (FDA).

CML is currently treated with tyrosine kinase inhibitor (TKI), Imatinib, although some patients develop a resistance due to the T315I mutation that renders the drug impotent. OMAPRO uses a different method to treat CML and is used when Imatinib ceases to have an effect.

OMAPRO is currently undergoing phase II and III clinical trials and has already received Orphan Drug designation in the US and the EU and received Fast Track status from the FDA.

“If approved, OMAPRO would be the first treatment specifically indicated for CML T315I patients, many of whom have no therapeutic options,” said Adam R. Craig MD, PhD, senior vice president and chief medical officer in a company statement. “We thank the investigators, their research staff and patients for participating in the pivotal study.”

ChemGenex (ASX:CXS) is down 4.4% to $0.66 in afternoon trading.