SYDNEY, Dec. 11, 2019
/PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ:
KZIA), an Australian oncology-focused biotechnology company, is
pleased to announce that it's lead program, GDC-0084, has been
selected to join GBM AGILE, an international, academic-led,
multi-drug adaptive phase II / III study in glioblastoma. It is
expected that data from GBM AGILE will be used to seek marketing
approval for GDC-0084 from FDA and other regulatory agencies.
Key Points
- GBM AGILE (NCT03970447) is an adaptive 'master protocol' study,
in which different drug candidates can be tested for potential use
in glioblastoma
- Study is designated phase II / III and data from it is
considered acceptable for product registration purposes by US
FDA
- Kazia has entered into a preliminary agreement to commence
planning and set-up activities for inclusion of GDC-0084 in GBM
AGILE, with a view to commencing recruitment in Q2 / Q3 CY2020,
subject to a definitive agreement
- Kazia plans to participate in GBM AGILE in place of a
company-run registration study, and GBM AGILE will serve as the
path-to-market for GDC-0084
- Study is expected to recruit up to 200 patients into the
GDC-0084 arm
Dr Timothy Cloughesy, GBM AGILE
Global Principal Investigator, commented, "We see an urgent need
for new therapies in glioblastoma, and GBM AGILE has been designed
to provide an opportunity for industry to test new therapeutic
agents in a cutting-edge, registration-level study, at considerably
lower cost and in a faster time than would typically be possible
for a company-driven study. GDC-0084 has the potential to become an
important treatment option for brain cancer, and this study is the
best way to definitively determine its efficacy in this challenging
disease."
GBM AGILE is sponsored and administered by the Global Coalition
for Adaptive Research (GCAR), a non-profit organization which
includes many of the world's leading scientists and clinicians in
the field of brain cancer (www.gcaresearch.org).
The study commenced recruitment of its first investigational arm
in June 2019. GBM AGILE is designed
as a 'master protocol' study, into which different drug candidates
can be placed for testing against a common control arm. It is an
'adaptive study', utilizing Bayesian statistical techniques to
dynamically adjust the number of patients in a given arm according
to emerging signals of activity. This minimizes redundant patient
recruitment, saving cost and time. The primary endpoint is overall
survival (OS), which is considered the 'gold standard' for the
approval of new cancer therapies by FDA and other regulatory
agencies. Participating drugs are first examined in a stage 1
(phase II) component, which then progresses seamlessly into a stage
2 (phase III) component once pre-defined efficacy hurdles are
met.
Dr James Garner, Kazia CEO,
commented, "GBM AGILE offers three enormous advantages to Kazia.
First, the highly innovative adaptive design allows us to test
GDC-0084 in the fastest and most cost-effective way possible.
Second, the considerable technical, scientific, and operational
capability in GCAR gives us access to resources that we could never
hope to draw upon otherwise. Third, the quality of the study, and
the caliber of the participating sites, means that GDC-0084 will
have the best possible opportunity to demonstrate its potential. No
company our size could run a study like this single-handedly, so we
have adopted GBM AGILE as our primary path-to-market strategy for
GDC-0084."
Dr Garner was speaking from the inaugural International
Glioblastoma Drug Development Summit in Boston, MA, where Kazia is an invited speaker.
The Summit has convened many of the leading researchers,
clinicians, and industry participants in the field of glioblastoma
to discuss new approaches to the development of novel
therapies.
GBM AGILE has the potential to test new drug candidates in
several different patient subgroups. In addition to the
newly-diagnosed unmethylated group, which Kazia has already
identified as the primary target population, the intent is to also
test GDC-0084 in recurrent patients. The company may consider
future use in newly-diagnosed methylated patients in consultation
with clinicians as further data becomes available.
Kazia and GCAR have entered into a preliminary agreement to
begin set-up work for inclusion of GDC-0084 in GBM AGILE, and it is
expected that this work will take approximately four to six months.
The proceeds of Kazia's recent institutional financing round will
be used to support these activities. Patient recruitment is
expected to begin in Q2 / Q3 CY2020, and will be contingent upon
execution of a definitive agreement between the parties.
Dr Meredith Buxton, COO of GCAR,
added, "The future of drug development requires new approaches,
particularly in challenging diseases such as glioblastoma. GBM
AGILE is scientifically rigorous, highly efficient, and
statistically innovative, and has been designed to provide the best
possible platform to generate new treatment options for patients.
We look forward to working with the Kazia team to bring GDC-0084
into the study as swiftly as possible."
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