SYDNEY, Nov. 29, 2021 /CNW/ -- Kazia Therapeutics
Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug
development company, is pleased to inform stakeholders that the GBM
AGILE study in glioblastoma (NCT03970447) has opened at Sunnybrook
Health Sciences Centre in Toronto,
Ontario. This marks the first Canadian site to open to
paxalisib, and the first opportunity for Canadian patients to
access the drug.
Sunnybrook Health Sciences Centre, under the leadership of
principal investigator, Dr James
Perry, will join more than two dozen US sites currently
recruiting to the paxalisib arm. Three further sites in
Canada are presently working
through the administrative requirements to open to paxalisib and
are expected to do so in coming weeks.
Key Points
- GBM AGILE is a multi-drug platform study, designed to identify
promising new therapies for glioblastoma. It is sponsored by the
Global Coalition for Adaptive Research (GCAR) and three drug
candidates are currently participating: Bayer's regorafenib,
Kazia's paxalisib, and VAL-083 from Kintara Therapeutics.
- The first US site opened to the paxalisib arm in January 2021. At present, more than two dozen US
sites are recruiting to the paxalisib arm.
- Sunnybrook Health Sciences Centre is the first Canadian site to
commence recruitment to the paxalisib arm, with several additional
sites in Canada expected to come
online during CY2021.
- Expansion of GBM AGILE to Europe and China is anticipated over coming months.
Dr James Perry, Professor of
Medicine at the University of Toronto,
Principal Investigator at Sunnybrook Health Sciences Centre, and
Lead Investigator for GBM AGILE in Canada, commented, "We are delighted to see
the study open new arms in Canada.
At least 1,200 Canadians are diagnosed with glioblastoma each year,
and the need for new treatment options has never been more acute.
My colleagues and I have been working closely with the Global
Coalition for Adaptive Research to bring this exciting and
innovative study to Canadian patients."
GBM AGILE
The paxalisib arm of GBM AGILE is recruiting two groups of
patients: newly diagnosed patients with the unmethylated MGMT
promotor, a genetic marker that denotes near-total resistance to
temozolomide, the existing FDA-approved standard of care, and
recurrent patients who have progressed despite treatment with
temozolomide. The paxalisib arm commenced recruitment in
January 2021 and has been recruiting
solely in the United States since
that time. The opening of McGill
University to the paxalisib arm represents the commencement
of clinical trial activity for paxalisib in Canada.
The primary endpoint of GBM AGILE is overall survival, which is
considered the gold standard for the evaluation of new cancer
therapies, and which is the preferred approval endpoint for
regulators such as the US FDA. Kazia expects GBM AGILE to serve as
the pivotal study for registration in key markets, including
Canada.
The study will recruit up to 200 patients on paxalisib in total,
and these will be compared against a shared control group. The
total data set for paxalisib will therefore likely include up to
approximately 450 patients from GBM AGILE. The duration of
paxalisib's enrolment is initially estimated to be approximately
30-36 months.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) is an
oncology-focused drug development company, based in Sydney, Australia.
Our lead program is paxalisib, a brain-penetrant inhibitor of
the PI3K / Akt / mTOR pathway, which is being developed to treat
glioblastoma, the most common and most aggressive form of primary
brain cancer in adults. Licensed from Genentech in late 2016,
paxalisib commenced recruitment to GBM AGILE, a pivotal study in
glioblastoma, in January 2021. Eight
additional studies are active in other forms of brain cancer.
Paxalisib was granted Orphan Drug Designation for glioblastoma by
the US FDA in February 2018, and Fast
Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted
Rare Pediatric Disease Designation and Orphan Designation by the US
FDA for DIPG in August 2020.
Kazia is also developing EVT801, a small-molecule inhibitor of
VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to
be active against a broad range of tumour types and has provided
compelling evidence of synergy with immuno-oncology agents. A phase
I study opened to recruitment in November
2021.
For more information, please visit www.kaziatherapeutics.com or
follow us on Twitter @KaziaTx.
This document was authorized for release to the ASX by
James Garner, Chief Executive
Officer, Managing Director.
About Sunnybrook
Sunnybrook Health Sciences Centre is inventing the future of
health care for the 1.3 million patients the hospital cares for
each year, through the dedication of its more than 10,000 staff and
volunteers.
An internationally recognized leader in research and education,
a full affiliation with the University of
Toronto distinguishes Sunnybrook as one of Canada's premier academic health sciences
centres. Sunnybrook specializes in
caring for high-risk pregnancies, critically ill newborns and
adults, offering specialized rehabilitation, and treating and
preventing cancer, cardiovascular disease, neurological and
psychiatric disorders, orthopaedic and arthritic conditions, and
traumatic injuries. The hospital also has a unique and national
leading program for the care of Canada's war veterans.
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SOURCE Kazia Therapeutics Limited