Australian oncology-focused biotechnology company Kazia Therapeutics (ASX:KZA) has announced it has executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to commence its participation in the GBM AGILE pivotal study in glioblastoma.
GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is an international platform study that has been established specifically to facilitate the approval of new medicines for glioblastoma.
The study will open a new arm with Kazia’s investigational new drug, paxalisib (formerly GDC-0084), and will now move into an operational phase with the recruitment of patients to the paxalisib arm expected to begin in early 2021.
Kazia CEO, Dr James Garner, said, “We have spent the last nine months or so working closely with the GCAR team to plan paxalisib’s entry into GBM AGILE, and we are very gratified to now be moving into the operational phase of the study.
"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. 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.”
Dr Meredith Buxton, CEO of GCAR, added, “We are pleased to welcome paxalisib into GBM AGILE. Our mission is to help drive the development of new therapies for glioblastoma, by creating an efficient model for testing and confirming new potentially beneficial treatments for patients with GBM. We look forward to continuing to work closely with the Kazia team to bring paxalisib into the study and support its evaluation.”