Singapore, April 14, 2008: ChemGenex Pharmaceuticals, a pharmaceutical development company based in Melbourne (Australia) and Menlo Park (USA) confirmed its intent to initiate a rolling New Drug Application (NDA) submission in support of omacetaxine mepesuccinate (formerly known as Ceflatonin) for the treatment of imatinib-resistant chronic myeloid leukemia (CML) patients with the T315I mutation in mid 2008. This decision follows a recent pre-NDA (New Drug Application) discussion with the US Food and Drug Administration (FDA).

 

It is anticipated that the rolling NDA submission will commence with the filing of the non-clinical section in mid 2008, followed by filings of the CMC (Chemistry and Manufacturing Controls) section and the clinical section in mid 2009.

 

The Fast Track designation granted for omacetaxine in November 2006 enables ChemGenex to file the NDA on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process.

 

Dr Greg Collier, Managing Director and Chief Executive Officer, ChemGenex Pharmaceuticals said, “T315I+ positive CML is an unmet medical need, and we will continue an active dialog with the FDA as we work towards filing the NDA package.”