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Sydney, 20 July 2022 – Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is lending its support to Glioblastoma (GBM) Awareness Day 2022 and remains firmly focused on developing a treatment that may help improve the lives of GBM patients worldwide.
GBM is the most common and most aggressive form of primary brain cancer, and approximately 13,400 Americans are expected to receive a GBM diagnosis in 2022. Survival and mortality rates have remained virtually unchanged for decades, as has the standard of care.
Kazia is hoping to change this with its drug paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma. Paxalisib is currently part of a multi-drug platform study known as GBM AGILE, which has been designed to identify promising new therapies for glioblastoma.
Currently there are over 40 GBM AGILE sites recruiting patients to the paxalisib arm of the study across the US, Canada and most recently Switzerland. More European sites are expected to open over the coming months, with expansion into China in 2H CY2022.
Kazia CEO, Dr James Garner, said, “Kazia is pleased to be supporting GBM Awareness Day again this year, and its mission to shine a light on the realities of GBM and raise awareness for patients and families who are living with this devastating disease. We are hopeful that more focus on the disease from industry, academia, government and the general population will help drive forward potential new treatment options to improve the prognosis of GBM patients.”
ABOUT GBM AWARENESS DAY
Glioblastoma Awareness Day is an annual event spearheaded by the National Brain Tumor Society. This year’s event will take place on Wednesday July 20, 2022 and will feature a #GBMDay virtual panel that brings together patients, caregivers, and leaders in research and treatment who are working for a brighter future for those with glioblastoma.
For more information about GBM Awareness Day, please visit https://braintumor.org/take-action/gbm-awareness-day/
ABOUT 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 the United States in January 2021 and in Canada in November 2021.
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 in the European Union.
Patients recruited to the paxalisib arm will be compared against a shared control group. The duration of paxalisib’s enrolment is initially estimated to be approximately 30-36 months, and final data is provisionally anticipated by the end of CY2023.
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. Seven additional studies are active in various 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 commenced 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.
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