Kazia Therapeutics presents Cantrixil data

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Kazia Therapeutics (ASX:KZA) has made its poster presentation summarising data from Part A of its ongoing phase 1 study of Cantrixil (TRX-E002-1) in ovarian cancer.

According to CEO Dr James Garner, “We are delighted to be able to share positive results from the first part of the Cantrixil phase I study in ovarian cancer, and it is very encouraging to have been selected to do so at a conference as prestigious as AACR.”

Part A of the study was performed at five sites in the US and Australia. Fourteen patients were enrolled in total, of which eleven received at least one dose of Cantrixil.

The company said, of nine patients evaluable for efficacy, five (56 per cent) achieved stable disease after two cycles of Cantrixil monotherapy. One of these five patients subsequently achieved a partial response when Cantrixil was administered with chemotherapy, as intended per protocol, it said.

Kazia said an expansion cohort of 12 patients is currently underway to seek efficacy signals.

Dr Garner continued, “Phase 1 studies are always primarily safety studies. The data from this study shows that Cantrixil has a safety profile very suitable for further development, and we have been able to reach a dose well within the predicted therapeutic range. It is extremely positive that we have seen some preliminary evidence of efficacy at this early stage in development, and the ongoing Part B of the study should give us much more information.”

Patients in the study received two cycles (six weeks) of therapy with Cantrixil alone, followed by up to six cycles (eighteen weeks) of Cantrixil administered in combination with standard-of-care chemotherapy. In total, 14 patients were enrolled in Part A. Three patients were withdrawn before receiving a first dose of Cantrixil due to rapid disease progression or other aspects of their pre-existing condition.

All patients had recurrent or persistent ovarian cancer and had failed at least two prior lines of therapy, including platinum therapy, prior to study entry, representing a very advanced population.

"After two cycles of treatment with Cantrixil, five of nine evaluable patients (56%) achieved stable disease, according to the industry-standard RECIST criteria, which means that the tumour remained approximately the same size over time and had not progressed," said the company.

"One of these patients subsequently achieved a partial response when Cantrixil was administered with standard-of-care chemotherapy, which means that the tumour was reduced in size by 30% or more.

"Four out of nine patients (44%) remained on study drug for the entire 24-week duration of the study (approximately six months), without experiencing progression of their disease. For comparison, data from other studies in a similar patient group has found a progression-free survival of approximately 3.4 to 4.7 months. This further suggests the possibility that Cantrixil may help to delay disease progression."