ChemGenex announces two new cancer trials

ChemGenex Pharmaceuticals (ASX:CXS) has outlined its accelerated clinical development plan for its lead anti-cancer therapeutic Ceflatonin, following positive results from initial trials.

The first of two registration-directed phase II/III trials is scheduled for the third quarter of 2005. The trials will target chronic myeloid leukaemia (CML) accelerated phase patients who are resistant to high-dose Gleevec. The single agent phase II/III trial will initially be conducted in six European cancer centres, and is expected to expand to incorporate cancer centres in the US in the first quarter of 2006.

The company said it had scheduled a second trial of Ceflatonin or homoharringtonine (HHT), following evidence from recent phase I/II studies that it had activity in CML patients who had developed bcr-abl point mutations associated with tyrosine kinase inhibitor resistance.

The second phase II/III clinical trial of Ceflatonin is aimed at treating CML patients with a specific gene mutation that makes them resistant to tyrosine kinase inhibitors such as Gleevec (the T3151 bcr-abl mutation). Due to commence in the US and Europe in the first quarter of 2006, up to 85 patients will be recruited.

In a statement, ChemGenex said the trial would incorporate the benefits of its recent in-licensing agreement with Stragen Pharma, and builds on growing clinical evidence that Ceflatonin has significant potential as a treatment for CML patients who are resistant to Gleevec and other experimental bcr-abl kinase inhibitors.

ChemGenex will continue with ongoing phase II clinical trial at the MD Anderson Cancer Centre in Houston, Texas.