SYDNEY, June 19, 2018 /PRNewswire/ -- Kazia
Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian
oncology-focused biotechnology company, is pleased to provide an
interim update to shareholders regarding its phase I clinical trial
of Cantrixil (TRX-E-002-1) in relapsed or recurrent ovarian
cancer.
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Of the 10 patients recruited to date, 2 were withdrawn from the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.
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