SYDNEY, March 29, 2018 /PRNewswire/ -- Kazia Therapeutics
Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology drug
development company, is pleased to announce commencement of an
international phase II clinical trial of its lead program,
GDC-0084.
Key Points
- First site, Stephenson Cancer Center at the University of Oklahoma, has been initiated and will
begin screening patients after the Easter holidays
- Study commencement follows a successful meeting with US Food
& Drug Administration (FDA) in September
2017, and approval by Western Institutional Review Board in
November 2017
- Initial focus will be on dose optimization in the treatment of
newly-diagnosed patients with glioblastoma multiforme; adaptive
study design will then seek to provide definitive evidence of
clinical efficacy
GDC-0084 is being developed for glioblastoma multiforme (GBM),
the most common and most aggressive form of primary brain cancer.
The mainstay of current pharmacological treatment, temozolomide, is
effective only in about one third of patients, and median survival
is approximately 12 to 15 months from diagnosis.
Kazia licensed GDC-0084 in late 2016 from Genentech, a member of
the Roche Group, where it had previously completed a phase I
clinical study in 47 patients with advanced glioma. Genentech's
phase I study demonstrated a favourable safety profile and provided
signals of efficacy. Genentech also conducted an extensive
preclinical program which showed encouraging results for GDC-0084
in animal models of glioblastoma.
Kazia CEO, Dr James Garner,
commented, "the entire team has been working hard to design and
implement the GDC-0084 clinical study. We are very pleased to now
have the trial underway, and look forward to working with the
participating clinicians. The need for new therapies in this
disease remains immense, and we believe that GDC-0084 may have a
valuable role to play in improving outcomes for patients with
glioblastoma."
This phase II study will initially be conducted predominantly at
leading US-based centres, in collaboration with specialist
clinicians in the neuro-oncology field, and under an
Investigational New Drug (IND) filing with the US Food and Drug
Administration. The study is awaiting registration with
clinicaltrials.gov, and will commence screening patients after the
Easter holidays. Not all patients will qualify, and some may
withdraw during the initial phase of the study. It is anticipated
that the study will provide an initial data read-out in early
calendar 2019.
A video interview of Dr James
Garner discussing the clinical study can be accessed via the
Kazia corporate website at
https://www.kaziatherapeutics.com/mediacentre/insight/why-gdc-0084-for-glioblastoma-qa-with-kazia-ceo-dr-james-garner.
The Company has also prepared an animation to explain the activity
of GDC-0084, and this can be accessed via the Kazia corporate
website at
https://www.kaziatherapeutics.com/mediacentre/insight/gdc-0084-and-glioblastoma-multiforme.
Commencement of the trial follows the decision of the US FDA to
grant orphan drug designation to GDC-0084 in glioblastoma in
February 2018. Since in-licensing the
program, Kazia has been working closely with clinicians and
advisors to build a comprehensive development program which aims to
move GDC-0084 towards a product registration in the swiftest and
most effective way. To date, this has included extensive regulatory
consultation, manufacture of drug product for use in the phase II
clinical trial, optimization of the intellectual property
portfolio, and implementation of additional animal studies to
support the further development of the drug.
Kazia Chairman, Iain Ross,
commented, "this is an important achievement for the organisation.
Two years ago, Kazia was an early-stage preclinical company. We now
have two high-quality assets in clinical trials: Cantrixil in phase
I for ovarian cancer and GDC-0084 in phase II for glioblastoma. The
Board and Management have completed a significant transformation of
the organization so as to optimally support this clinical-stage
portfolio, and we are now a lean, cost-effective, and
highly-focused biotech."
He added, "we continue to be pleased with progress on the phase
I study of Cantrixil, and look forward to reporting initial data
from this study, which we expect will occur in the second calendar
quarter of 2018."
[ENDS]
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.
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 is expected in the second
quarter of calendar 2018.
For more information, please visit www.kaziatherapeutics.com