The poster which was presented at the ESMO conference included data from all nine patients in the dose escalation part of the study (Part A).
Two of the nine patients or 22% were considered to have achieved a ‘partial response’ to Cantrixil therapy and three further patients were evaluated as ‘stable disease’.
Notably, the median progression-free survival for all patients in Part A was calculated to be 5.5 months compared to historical controls in a similarly advanced population of 3.4 months.
This suggests Cantrixil may help to delay tumour recurrence.
Cantrixil is currently being developed for treatment of ovarian cancer and is being trialled in hospitals across Australia and the US under an Investigational New Drug application which was approved by the US FDA in 2016.
The drug is active
Kazia’s CEO Dr James Garner added: “It is terrific to see further very promising data emerging from the Cantrixil phase I study.
“Put simply, the drug is active. The expansion cohort, which is currently in progress, will help us to further quantify and substantiate that activity.
“In parallel, we continue to discuss the program with clinicians, potential partners, and investors, as we consider how best to take Cantrixil forward after completion of the phase I study.”
Part B data expected in 2020
Part B of the study completed the recruitment of 12 patients at the maximum tolerated dose (MTD) in August 2019 to seek preliminary signals of efficacy.
Kazia expects to report data from this component of the study early in calendar 2020.
Patients showing evidence of clinical response
Australian lead investigator for the study, Associate Professor Jim Coward said: “We have made excellent progress with the Cantrixil study.
“We are seeing several patients now with potential evidence of clinical response. Interestingly, some early signs are emerging that the drug may help to reverse chemotherapy resistance, supporting the preclinical data that was originally collected at Yale.
“The expansion cohort is fully recruited, and my colleagues and I look forward to seeing further data in due course.”