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Cheryl-Anne
ChemGenex to trial leukaemia drug
Tuesday Jun 13 16:41 AEST
Biotechnology firm ChemGenex Pharmaceuticals Ltd has launched a new trial of its leukaemia drug, Ceflatonin.
The international trial involves
patients with chronic myeloid leukaemia (CML) who have developed a resistance to
the current treatment, Novartis AG's drug Gleevec.
ChemGenex said Ceflatonin had recently
been granted orphan drug status - granted to drugs that can fulfil a potential
unmet need - by the United States' Food and Drug Administration
(FDA).
ChemGenex said this suggested that
Ceflatonin should proceed quickly to registration after completion of the latest
trials which are expected to take about 12 months.
The phase 2/3 trial will involve about
15 clinical centres globally, particularly in the United States, France and
Germany.
ChemGenex expects to be able to file
with the US FDA by mid-2007.
Ceflatonin targets the most common
resistance to Gleevec: the T315I mutation.
By 2004, up to 30 per cent of CML
patients were estimated to be resistant to Gleevec.
ChemGenex said Novartis had a drug
targeting patients with resistance to Gleevec but it was in the pre-clinical
phase and only likely to go into Phase 1 trials in 2007.
Sales of Gleevec for CML patients
amounted to $US630 million in 2004.
ChemGenex said pharmaceutical
giant Bristol Myer Squib's new drug, dasatinib, which has recently been approved
by the US FDA, targets patients with resistance to Gleevec but is not effective
against patients with the T315I mutation. ChemGenex vice-president of operations, James Campbell, said 80 per cent
of the 40,000 to 50,000 patients with CML in the US were treated in only about
20 hospitals.
Because the final product would be aimed
at clinicians rather than consumers, ChemGenex might choose to market a final
product to hospitals itself rather than with a partner.
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