The phase I study of Cantrixil commenced in December 2016 at five centres in the United States and Australia. It is designed in two parts: a dose escalation component (Part A), which seeks to understand the safety profile of the drug and to determine the maximum tolerated dose (MTD), and a dose expansion cohort (Part B), which seeks to explore initial signals of efficacy. Part A is expected to enroll between 3 and 42 patients, and Part B is expected to enroll 12 patients. The study is registered with clinicaltrials.gov as NCT02903771.
At the present time, the study has enrolled 10 patients in Part A. In general, the drug has encountered few dose-limiting toxicities and, as a result, most dosing cohorts have only required enrolment of a single patient, in line with the trial protocol, which has allowed the study to progress with a number of patients towards the lower extent of the forecast range.
Of the 10 patients recruited to date, 2 were withdrawn from the study prior to receiving treatment, generally on grounds of disease progression, reflecting the severity of this patient population. 3 of 5 patients evaluable for efficacy thus far have achieved ‘stable disease’ (SD) per RECIST criteria after 2 cycles of Cantrixil monotherapy. One patient demonstrated a ‘partial response’ (PR) after receiving Cantrixil in combination with chemotherapy. 3 patients have so far completed the full twenty-four weeks of dosing allowed for in the protocol.
The Data Monitoring Committee has recommended that additional patients should be enrolled to more fully understand the safety profile and to definitively determine the maximum tolerated dose, and the company has therefore continued Part A accordingly. It is now expected that Part A will conclude in the third calendar quarter of 2018, at which time Part B will commence. The Company expects to provide comprehensive data once Part A is complete.
Kazia CEO, Dr James Garner, commented, “We are pleased with the progress of the study to date. Our understanding of both the safety and potential efficacy of Cantrixil will evolve as the study progresses further, and we look forward to sharing additional data as it is determined.”
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications.
Our lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer. Licensed from Genentech in late 2016, GDC-0084 entered a phase II clinical trial in March 2018. Initial data is expected in early calendar 2019, and the study is expected to complete in 2021.
TRX-E-002-1 (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells, and is being developed to treat ovarian cancer. TRX-E-002-1 is currently undergoing a phase I clinical trial in Australia and the United States. Initial data was presented in June 2018 and the study remains ongoing.
SOURCE Kazia Therapeutics Limited