CHEMGENEX RECEIVES FAST-TRACK STATUS FOR CEFLATONIN IN CML

ChemGenex Pharmaceuticals announced that its investigational drug Ceflatonin (homoharringtonine, HHT) has been awarded fast-track status by the FDA for the treatment of patients with chronic, accelerated and blast-phase chronic myeloid leukemia (CML) who have failed on Gleevec and have the T315I bcr-abl point mutation.

Ceflatonin is a potent inducer of apoptosis (programmed cell death) in myeloid cells and inhibits angiogenesis (blood vessel formation). In Phase II studies, the drug has demonstrated clinical activity in patients with CML, both as a single agent and in combination with other chemotherapeutic drugs. ChemGenex is developing Ceflatonin for the treatment of CML, and pilot studies are under way in myelodysplastic syndrome (MDS) and in acute myeloid leukemia (AML).

Ceflatonin has a different mechanism of action than tyrosine kinase inhibitors (TKIs), and ongoing and proposed clinical studies will seek to determine the drug's efficacy in treating: CML patients who have developed resistance to tyrosine kinase inhibitor (TKI) therapy due to development of the T315I bcr-abl kinase domain point mutation; CML patients who have failed therapy with two tyrosine kinase inhibitors like Gleevec and Sprycel; and residual disease and to prolong Gleevec sensitivity CML patients who have developed resistance to Gleevec.