Benzinga | Nov 29, 2021 08:06AM EST

Kazia Therapeutics Announces The GBM AGILE Study In Glioblastoma Has Opened At Sunnybrook Health Sciences Centre In Toronto, Ontario

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.