Kazia Therapeutics’ (ASX: KZA) lead drug GDC-0084 has been selected for use in GBM AGILE, which is an international academic-led glioblastoma study.
According to Kazia, GBM AGILE is an adaptive phase II/phase III study that will test multiple drug candidates for potential use in treating glioblastoma, which is the most common and aggressive form of brain cancer in adults.
Backing the study is the Global Coalition for Adaptive Research (GCAR), which is a non-profit organisation comprising some of the world’s leading scientists and clinicians in the brain cancer field.
GBM AGILE global principal investigator Dr Timothy Cloughesy said there was an “urgent need” for new glioblastoma treatments.
He added the study provides an opportunity for industry to test new therapeutic agents in a cutting-edge, registration level study that is “considerably lower cost” and takes less time than a company driven trial.
“GDC-0084 has the potential to become an important treatment option for brain cancer, and this study is the best way to definitively determine its efficacy in this challenging disease,” Dr Cloughesy said.
Once a binding agreement has been executed, Kazia expects recruitment for the study will begin in the June or September quarter next year with 200 patients to be recruited for the GDC-0084 arm.
With the US Food and Drug Administration and other regulatory agencies accepting GBM AGILE data, Kazia anticipates the trial will provide a path to market for its GDC-0084.
“GBM AGILE offers three enormous advantages to Kazia,” Kazia chief executive officer Dr James Garner said.
“First, the highly innovative adaptive design allows us to test GDC-0084 in the fastest and most cost-effective way possible.”
“Second, the considerable technical, scientific and operational capability in GCAR gives us access to resources that we could never hope to draw upon otherwise.”
He added the third advantage was the quality of the study and calibre of participating sites would give GDC-0084 the best opportunity to demonstrate its potential.
Promising early results
Last month, Kazia reported early data from its own phase 2 study into the effects of GDC-0084 in newly diagnosed glioblastomas had shown the drug may delay the cancer’s progression.
At the time, Kazia said it was too early to calculate overall survival, but 75% of patients were still alive at the cut-off date signalling GDC-0084 may provide clinical benefits.
“The fact that the majority of patients in the first stage of the study remain alive more than a year after diagnosis suggests that a meaningful overall survival benefit may emerge as the study matures … that would be a remarkable finding,” Dr Garner said.
Kazia’s shares lifted almost 4% in early morning trade to reach $0.665.