SYDNEY, July 22, 2019 /PRNewswire/ -- Kazia Therapeutics
Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused
biotechnology company, is pleased to announce that Memorial Sloan
Kettering Cancer Center (MSK) in New
York, NY will investigate the potential use of Kazia's
investigational new drug, GDC-0084, in combination with
radiotherapy in a phase I clinical trial for cancer that has spread
to the brain (brain metastases and leptomeningeal metastases). This
research will explore a new use of GDC-0084 and will run
concurrently with other ongoing studies in different forms of brain
cancer.
![Logo Logo](https://mma.prnewswire.com/media/766762/Kazia_Logo.jpg)
Dr James Garner, Chief Executive
Officer of Kazia Therapeutics commented, "MSK is one of the world's
leading cancer treatment centers, and we are privileged to be
supporting them in this state-of-the-art project. Many cancers have
the potential to spread to the brain, and they become very
difficult to treat when they do. The work being done at MSK will
investigate whether GDC-0084 has the potential to enhance the
effects of radiotherapy, which remains the current standard of care
in most cases."
Key Points
- MSK will initiate a phase I clinical trial of GDC-0084 in
combination with radiotherapy for patients with solid tumor brain
metastases (cancer that has spread to the brain) and leptomeningeal
metastases that harbors a genetic alteration in the PI3K
pathway.
- The trial is expected to recruit 18-30 patients and will take
about two years to complete.
- The trial will be led by MSK, with Kazia providing support
including study drug and a financial grant.
- Initiation of this study brings to five the total number of
ongoing clinical trials with GDC-0084, each in different forms of
brain cancer.
Up to 30% of patients with metastatic cancer will develop
secondary tumors (metastases) in the brain. Radiotherapy remains
the standard of care, but 30-50% of patients will progress within
one year, despite best available treatment. In animal models of
certain cancers, activation of the PI3K pathway has been shown to
contribute to radiotherapy resistance. GDC-0084 is a PI3K inhibitor
that can cross the blood-brain barrier, and as such it may be able
to reduce the problem of resistance to radiotherapy. This clinical
trial has been developed to test that hypothesis.
The trial is expected to recruit 18-30 patients, all of whom
will have cancer that has spread to the brain. Patients will be
genetically tested for a specific alteration in the PI3K pathway,
and only those with a relevant mutation will be enrolled. This is
an example of an approach to clinical research that is sometimes
referred to as 'precision medicine' or 'personalized medicine', in
which treatments are carefully targeted to those patients most
likely to benefit. It is expected that the trial will begin
recruitment in the second half of calendar 2019.
The study in two parts. The first part will aim to determine the
maximum tolerated dose (MTD) of GDC-0084 when given together with
radiotherapy. Once that dose has been determined, the second part
of the study will enroll an additional twelve patients at that dose
to explore preliminary signals of efficacy.
The Principal Investigator for the study is Dr T Jonathan Yang,
Director of Metastatic Disease Program in MSK's Department of
Radiation Oncology. Dr Yang is a graduate of Yale University School of Medicine and a
Board-certified radiation oncologist, with a specialist interest in
treating tumors of the central nervous system. He is an
extensively-published clinical researcher who has participated in a
substantial number of clinical trials in brain cancer.
The initiation of the study brings to five the number of ongoing
clinical trials with GDC-0084:
Sponsor
|
Phase
|
Indication
|
Registration
|
Kazia
Therapeutics
|
II
|
Glioblastoma
|
NCT03522298
|
Alliance for Clinical
Trials in Oncology
|
II
|
Brain
metastases
|
NCT03994796
|
Dana-Farber Cancer
Institute
|
II
|
Breast cancer brain
metastases
(with
Herceptin)
|
NCT03765983
|
St Jude Children's
Research Hospital
|
I
|
DIPG (childhood brain
cancer)
|
NCT03696355
|
Memorial Sloan
Kettering Cancer Center
|
I
|
Brain
metastases
(with
radiotherapy)
|
(TBA)
|
It is expected that the study will take approximately two years
to complete. Kazia will provide support, including a financial
grant for a portion of the costs. The study will be conducted under
an 'investigator IND' with the US FDA, in which the primary
regulatory responsibilities for the study will be assumed by MSK.
Implementation of the study is conditional upon approval from the
Institutional Review Board at MSK, and this approval has yet to be
obtained.
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, GDC0084 entered a phase II clinical trial in 2018. Initial
safety data was released in May 2019,
and efficacy data is expected in 2H 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 at the AACR annual
conference in April 2019 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 Ltd