- Oncology biotech company, Kazia Therapeutics' (KZA) paxalisib drug joins GBM AGILE pivotal study in glioblastoma
- Glioblastoma is aggressive cancer that occurs in the brain or spinal cord
- GBM AGILE is an international study that was formed to facilitate the approval of new medicines for glioblastoma
- One drug candidate is participating in the study and paxalisib will be the second drug to join
- On market close, Kazia remains flat and trading for 79.5 cents per share
Oncology biotech company, Kazia Therapeutics' (KZA) paxalisib drug joins GBM AGILE pivotal study in glioblastoma.
The company has signed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to commence the study.
Glioblastoma is an aggressive cancer that occurs in the brain or spinal cord.
Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) is an international study that was formed to facilitate the approval of new medicines for glioblastoma.
The leadership team behind GBM AGILE includes leading experts in glioblastoma and have worked in collaboration with the U.S. food and drug administration (FDA). It is sponsored by GCAR, a U.S. based non-profit organisation.
Currently the study is underway at 30 sites in the U.S. and Canada, with plans to launch in Europe and China in 2021.
One drug candidate is currently participating and paxalisib will be the second drug to join the study.
The study will open new doors for Kazia's new drug, paxalisib. It is expected that between 50 and 200 patients will receive paxalisib, depending on the saftey and efficany of the drug.
Kazia will pay an initial US$5 million (around A$7 million) to GCAR for paxalisib to join GBM AGILE.
CEO Dr James Garner said the company has spent the last nine month working with GCAR to plan paxalisib's entry into GBM AGILE.
"GBM AGILE is truly a ground-breaking clinical trial, driven by some of the world’s leading experts in the field, and we are proud to be a part of it. We
expect GBM AGILE to provide definitive clinical evidence for the approval of paxalisib by regulatory agencies in key markets," he said.
"This is a faster, more cost-effective, and higher quality study than any
company of our size could mount independently, and we are confident that it will provide the best possible opportunity for paxalisib to demonstrate its potential in this very challenging disease," he added.
Dr Indo Mellinghoff and Dr Eudocia Q Lee will be the principal investigators for the paxalisib arm.
Indo said he has seen little progress in the treatment of glioblastoma for over
two decades and there is an urgent need for new therapies.
"We have seen encouraging signals from the paxalisib program thus far, and my colleagues and I look forward to exploring its potential in the GBM AGILE pivotal study," he added.
On market close, Kazia remains flat and trading for 79.5 cents per share