SYDNEY, Oct. 10, 2018
/PRNewswire/ -- 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.
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 in adults. 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. GDC-0084 was granted orphan designation for
glioblastoma by the US FDA in February
2018.
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.
Cantrixil was granted orphan designation for ovarian cancer by the
US FDA in April 2015.
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SOURCE Kazia Therapeutics Limited