GDC-0084 is being developed for glioblastoma multiforme, the most common and most aggressive form of primary brain cancer.
Chemotherapy treatment temozolomide is only effective in one-third of patients.
Furthermore, the median survival rate is 12 to 15 months from diagnosis, meaning there is a demand in the market for superior treatments.
Kazia’s CEO Dr James Garner said: “The need for new therapies in this disease remains immense, and we believe that GDC-0084 may have a valuable role to play in improving outcomes for patients with glioblastoma.”
FDA grant in February paved way for phase II clinical trial
Commencement of the trial follows the decision of the US FDA to grant orphan drug designation to GDC-0084 in glioblastoma in February 2018.
This phase II study will initially be conducted predominantly at leading US-based centres.
The study will commence screening patients after the Easter holidays.
It is anticipated that the study will provide an initial data read-out in early calendar 2019.
Phase II builds on a successful phase I study
Kazia licensed GDC-0084 in late 2016 from Genentech, a member of the Roche Group, where it had previously completed a phase I clinical study in 47 patients with advanced glioma.
Genentech’s phase I study demonstrated a favourable safety profile and provided signals of efficacy.
Genentech also conducted an extensive preclinical program which showed encouraging results for GDC-0084 in animal models of glioblastoma.
Two clinical-stage programs
Kazia is an emerging cancer-focused biotech with two clinical-stage programs.
As well as GDC-0084, Kazia is developing Cantrixil to treat ovarian cancer which is currently in phase I trial.
Kazia expects a read-out of maximum tolerated dose and safety from its phase I study in ovarian cancer in the current June half.