Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA)'s cancer drug, paxalisib, which targets glioblastoma, will now reach patients in Canada through a new study at Sunnybrook Health Sciences Centre in Toronto, Ontario.
The company’s flagship drug, paxalisib, is a candidate in GBM AGILE, a multi-drug platform study designed to identify promising new therapies for glioblastoma.
Sponsored by the Global Coalition for Adaptive Research (GCAR) and under the leadership of principal investigator Dr James Perry, Professor of Medicine at the University of Toronto and Lead Investigator for GBM AGILE in Canada, the study will trial Bayer’s regorafenib and Kintara Therapeutics (NASDAQ:KTRA)’ VAL-083 alongside paxalisib.
Sunnybrook Health Sciences Centre, one of Canada’s premier academic health sciences centres, joins more than two dozen US sites working with paxalisib since the start of this year.
“We are delighted to see the study open new arms in Canada,” Perry said.
“More than 1,200 Canadians are diagnosed with glioblastoma each year, and the need for new treatment options has never been more acute.”
Expansion into Canada and beyond
Sunnybrook’s participation marks the first opportunity for Canadian patients to access the drug.
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.
The Sydney-based drug development company expects the pivotal study to reach Europe and China in the coming months.
About paxalisib
Brain-penetrant inhibitor paxalisib is being developed by Kazia 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.
It was also granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for the highly aggressive brain tumour, diffuse intrinsic pontine glioma (DIPG), in August 2020.