Chemgenex expands trial to include breast and ovarian cancers

Melbourne and California-based ChemGenex Pharmaceuticals (ASX:CXS) has expanded phase II clinical trials of its investigational anti-cancer drug Quinamed to include patients with breast and ovarian cancer.

"Chemgenex is at the cutting edge of personalised medicine and we see the expansion of these clinical trials as important," said ChemGenex' vice-president of operations, James Campbell. "We always flagged our intention to maximise the number of diseases to make sure that we are choosing the best indication into phase III trials. The inclusion of patients with breast and ovarian cancer was based on the positive earlier clinical trial data".

In June 2004 ChemGenex reported promising results from a phase I trial of 32 patients with prostate, ovarian, breast and colon cancers and commenced trials of patients with prostate cancer late last year.

ChemGenex expects to complete the phase II study of Quinamed (amonafide dihydrochloride) in the first half of 2006. The expansion of the existing study, which already has 13 patients, has resulted in an increase in patient numbers to a total of up to 42, with 14 patients in each cancer group. The primary endpoints of the study are tumour response rate and duration of response. Phase III studies could follow by late 2006.

ChemGenex' personalised medicine approach with Quinamed uses a genetic test to classify how each patient will metabolise the drug. The test, for variations in the NAT2 gene is used to design a personalised dosing regimen that seeks to maximise anti-tumour response while minimising toxicity.

"Drug doses for specific patients are tailored to those patients' genetic makeup," said Campbell.

Patients will be genotyped when entering the study and then dosed once weekly for three weeks each month at 400-500 mg/m2, if they are slow metabolisers, and at 320 mg/m2, if they are fast or intermediate metabolisers.

ChemGenex CEO Greg Collier said phase II results in more than one indication would help with partnering discussions from next year.