ASX RELEASE
10 October
2018
CANTRIXIL PHASE I STUDY PROGRESSES TO NEXT STAGE
Sydney, 10 October 2018 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to
announce the successful completion of Part A, the dose escalation component, of its phase I study of Cantrixil in ovarian cancer.
After discussion
by the Data Monitoring Committee, the study has determined a maximum tolerated dose (MTD) of 5 mg/kg, and it is expected that this dose will be used for subsequent clinical investigation. Preclinical data suggests that this dose should be sufficient
to detect potential therapeutic effects of Cantrixil.
The study will now move into Part B, a dose expansion cohort, which is designed to seek preliminary
evidence of efficacy. Part B will recruit a further 12 patients, all of whom are expected to be dosed at the MTD of 5mg/kg. The company expects to be able to conclude Part B in calendar 2019.
Kazia CEO, Dr James Garner, commented, “we are delighted with progress in the Cantrixil study. The first hurdle for any drug in development is safety,
and so it is highly encouraging that we have achieved in Part A of the trial a dose for Cantrixil towards the upper end of the range that we set out to explore. The study will now immediately transition into Part B, which will provide important
insights into the potential efficacy of Cantrixil, building on the preliminary data that was announced in June 2018. We are grateful to the clinicians and patients who have driven the study forward so far, and we look forward to seeing further
progress in due course.”
To date, 14 patients have been enrolled in the Cantrixil phase I study, all with ovarian cancer that has failed at least
two prior lines of treatment and, of these, 11 have been well enough to receive treatment with Cantrixil. The most common side effects seen with Cantrixil administration have been abdominal pain, fatigue, and vomiting. Several patients continue to
receive study drug at this time and as a result no further interim efficacy data is available at this point. The company is planning opportunities for publication of emerging safety and efficacy data with participating clinicians, and looks forward
to sharing a comprehensive analysis in the near future, within the context of a suitable academic forum or publication.
[ENDS]
Board of Directors
Mr Iain Ross
Chairman,
Non-Executive Director
Mr Bryce Carmine
Non-Executive Director
Mr Steven Coffey
Non-Executive Director
Dr James Garner
Chief Executive Officer, Managing Director