GDC-0084 is an orally-administered therapy which is under development as a treatment for glioblastoma multiforme (GBM), the most common and most aggressive form of brain cancer.
GBM affects circa 130,000 patients worldwide annually, and has one of the poorest outcomes of any cancer, with only 3-5% of patients alive five years after diagnosis.
The GDC-0084 therapy is designed to inhibit tumour growth by targeting an important biochemical control mechanism that is thought to be critical to the growth of the tumour.
GDC-0084 was licensed by Novogen from Genentech, a member of the Roche Group, in October 2016.
Since the transaction, Novogen has completed the transfer of the FDA Investigational New Drug (IND) application from Genentech to Novogen.
Novogen has also taken possession of around 48.8 kilograms of premanufactured drug substance that had been prepared by Genentech in anticipation of a phase II study.
This material is now being formulated into oral capsules for use in the phase II clinical trial.
The study will be a randomized, two-arm study with 200 patients receiving either GDC-0084 or temozolomide as maintenance therapy after completion of standard radiotherapy treatment.
The primary endpoint of the study will be progression-free survival (PFS), with patients followed for overall survival.
PFS can be considered an acceptable endpoint for approval of oncology drugs by FDA.
Novogen anticipates that the phase II study will commence in the second half of calendar 2017, and will take circa 18 months to reach full recruitment, with PFS data available 12 months thereafter.