australian life scientist mention

4/5/2010 - Tim Dean

ChemGenex recently suffered a setback in its quest to bring its targeted leukaemia therapy, Omapro (omacetaxine mepesuccinate), to market. The drug is a second line therapy for individuals with chronic myeloid leukemia (CML) who have the T315I mutation, making them unresponsive to the first line treatment, imatinib, which is known as Glivec in Australia and Gleevec in the US. Omapro is an impressive drug for these individuals, effectively halting leukaemia in its tracks.

The FDA Oncologic Drugs Advisory Committee acknowledges all this, but in March it ruled that before Omapro can get the go-ahead, there needs to be a diagnostic for the T315I mutation approved by the FDA. There are already a number of such diagnostics about, but none have regulatory approval from the FDA. ChemGenex is now furiously working to help get one approved so it can get on with marketing Omapro. The companys stocks took a dive following the announcement, but assuming a diagnostic is approved in reasonable time, and Omapro not far behind, the potential for ChemGenex is terrific.