SYDNEY, Oct. 22, 2018 /PRNewswire/ -- The Australian
oncology-focused biotech Kazia Therapeutics announced today that it
will collaborate with world-leading treatment and research centre
Dana-Farber Cancer Institute to investigate the use of Kazia's
potential new therapy for brain cancer, GDC-0084, in breast cancer
that has spread to the brain.
The phase 2 clinical trial will investigate the effects of
GDC-0084 in combination with the current standard of care,
Herceptin (trastuzumab), in patients with HER2-positive breast
cancer that has metastasised to the brain. About 10-15% of women
with stage IV breast cancer develop brain
metastases, according to Breastcancer.org.
The study is estimated to recruit between 22 and 49 patients,
and will take up to three years to complete.
Kazia is developing GDC-0084 as a potential treatment for the
primary form of brain cancer, glioblastoma multiforme. The drug targets the signaling pathway
implicated in about 90% of glioblastoma cases, and is
differentiated from other brain cancer treatments by its ability to
cross the so called 'blood-brain' barrier that prevents many drugs
from fully impacting the brain.
Kazia CEO, Dr James Garner said:
"We strongly believe in the potential for GDC-0084 to bring benefit
to patients with other forms of brain cancer beyond glioblastoma,
and it is exciting to be working with the team at Dana-Farber to
explore its potential use in this very challenging disease. It is
extremely rewarding to be able to work with specialist researchers
of this calibre, at a centre held in such high reputation, and we
are committed to seeing this important study move forward."
Explaining the rationale behind the investigation of GDC-0084 as
a HER2-positive breast cancer treatment, Kazia's GDC-0084 Clinical
Program Director Dr Jeremy Simpson
said:
"HER2 is a protein that promotes the growth of cancer
cells. Approximately 20-30% of early-stage breast cancers show
amplification of a gene associated with HER2, and these patients
are generally treated with Herceptin, an anti-HER2 monoclonal
antibody.
"The efficacy of Herceptin is well established. However, breast
cancer can nevertheless spread to other parts of the body, a
process described as metastasis, and in about a third of such cases
the brain is the site to which it spreads. Such brain metastases
are often highly resistant to Herceptin, in contrast to the primary
tumour, and there remains a substantial need for new therapies in
this patient population. Recent research suggests that the PI3K
pathway may represent an important part of this resistance
mechanism, and so there is a sound rationale to explore GDC-0084, a
brain-penetrant PI3K inhibitor, as a potential treatment for
patients with breast cancer that has metastasized to the
brain."
The Dana-Faber study will run alongside an ongoing phase II
clinical trial of GDC-0084 in adults with newly-diagnosed
glioblastoma. Trial sites are open in the US, with further sites to
open in Australia in 2019.
Dana-Farber Cancer Institute is based in Boston, Massachusetts, and is a principal
teaching affiliate of Harvard Medical
School.
Analysts forecast that the HER2-positive treatment market is
estimated to reach $12.7 billion by
2023[1].
[1] September 2014,
Her-2 Positive Breast Cancer Global Drug Forecast and Market
Analysis to 2023, Global Data PharmaPoint, GDHC86PIDR
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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