Clinical study commences for brain cancer drug
Kazia Therapeutics, an Australian oncology drug development company, has announced the commencement of an international phase II clinical trial of its lead program, GDC-0084.
A small molecule inhibitor of the PI3K/AKT/mTOR pathway, GDC-0084 is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer. The mainstay of current pharmacological treatment, temozolomide, is effective only in about one-third of patients, and median survival is approximately 12–15 months from diagnosis.
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.
The phase II study will initially be conducted predominantly at leading US-based centres, in collaboration with specialist clinicians in the neuro-oncology field, under an Investigational New Drug (IND) filing with the US FDA. Commencement of the trial follows the decision of the FDA to grant orphan drug designation to GDC-0084 in glioblastoma in February 2018.
Since in-licensing the program, Kazia has been working closely with clinicians and advisers to build a comprehensive development program which aims to move GDC-0084 towards a product registration in the swiftest and most effective way. This has included extensive regulatory consultation, manufacture of drug product for use in the phase II clinical trial, optimisation of the intellectual property portfolio and implementation of additional animal studies to support the further development of the drug.
“The entire team has been working hard to design and implement the GDC-0084 clinical study,” said Kazia CEO Dr James Garner. “We are very pleased to now have the trial underway and look forward to working with the participating clinicians. 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.”
It is anticipated that the study will provide an initial data read-out in early 2019.
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