Kazia Therapeutics: GDC-0084 Phase Ii To Begin Shortly
Edison | Dec 21, 2017 05:15AM ET
Novogen has changed its name to Kazia Therapeutics Ltd ADR (NASDAQ:KZIA) and undertaken a 10:1 share consolidation following shareholder approval in November. It has also out-licensed its preclinical super-benzopyran development programme, and has added a dose optimisation lead-in component to the Phase II trial of GDC-0084 in glioblastoma, which is expected to commence in early 2018. Although the more focused pipeline and longer Phase II trial for GDC-0084 prompts us to trim our valuation to between A$69m and A$127m, we believe the changes will be positive in the long run, increasing the chance of success in the GDC-0084 development programme.
GDC-0084 Phase II to start early in the new year
Kazia is on track to initiate a Phase II study of its oral PI3K inhibitor GDC-0084 in glioblastoma early in the new year. It has received its first ethics committee approval and the US site will open for recruitment in early 2018. The trial design now includes a lead-in component to optimise dosing before the randomised study begins. Identifying an optimised dosing regimen would be likely to increase the prospects of success for the Phase II study, which compensates for the extra 12-15 months it is expected to add to the overall Phase II programme. The open-label lead-in should provide an initial data readout in late 2018 or early 2019.
Kazia Therapeutics GDC-0084 Phase Ii To Begin Shortly
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