NEW YORK – Kazia Therapeutics and Kintara Therapeutics said on Thursday that studies involving their drugs will begin enrolling patients within the GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) platform trial.
Within GBM AGILE, an international adaptive study sponsored by the Global Coalition for Adaptive Research (GCAR), collaborators aim to find new treatments for glioblastoma. The study's design allows for multiple therapies from different pharma companies to be evaluated simultaneously.
Kazia, based in Australia, began a trial of its drug, paxalisib, in newly diagnosed unmethylated and recurrent glioblastoma. California-based Kintara's drug, VAL-083, is being evaluated in newly diagnosed patients with both unmethylated and methylated MGMT glioblastoma.
Paxalisib is a PI3K/AKT/mTOR pathway inhibitor that Kazia licensed from Genentech in 2016. Kintara's drug, VAL-083, is a small-molecule chemotherapeutic. The paxalisib and VAL-083 studies will be open for enrollment at more than 30 sites across the US, with additional global sites in Canada, Europe, and China to follow.
"This is an important and innovative effort, utilizing a platform approach and cutting-edge adaptive design to rapidly identify whether drugs such as paxalisib can bring benefit to patients with glioblastoma," James Garner, Kazia CEO, said in a statement. "There is a profound need for new therapeutic options in this disease, and GBM AGILE has been designed to accelerate the process of making new drugs available to patients and clinicians. We have seen encouraging data with paxalisib in earlier clinical studies, so we hope that success in GBM AGILE may pave the way to providing a new treatment in this disease."