ChemGenex leukemia drug given orphan status in US

Ceflatonin is the first of a new class of novel drugs that induces programmed cell death and inhibits the formation of new blood vessels that support the tumor.

Ongoing or soon to be initiated clinical trials will be evaluating Ceflatonin in a broad range of conditions, including: chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Orphan drug status is granted by the FDA to promote the development of drugs for diseases affecting less than 200,000 people in the US. Orphan drug status entitles ChemGenex to seven years of market exclusivity for the use of Ceflatonin in the treatment of CML; protocol assistance by the FDA to optimize drug development in the preparation of a dossier that will meet regulatory requirements; and reduced fees associated with applying for market approval.

A similar designation for Ceflatonin in the European market, with similar advantages, was granted by the European Union in September 2004.

“The decision by the US FDA to grant Ceflatonin orphan drug status for CML is further incentive to move Ceflatonin as quickly as possible through the clinical development and regulatory approval process worldwide,” said Greg Collier, ChemGenex CEO and managing director.