A Phase 2 trial evaluating Novogen‘s GDC-0084 therapy in glioblastoma patients should begin by year’s end, the Australian company announced.
“The GDC-0084 study is on track to commence this year, in line with our prior guidance to the market,”Dr. James Garner, CEO of Novogen, said in a press release. “Novogen has made excellent progress in designing and setting up a world-class clinical trial for this exciting potential new treatment. The need for new therapeutic options in brain cancer is substantial, and we hope that GDC-0084 will have an important role to play.”
GDC-0084 is a small molecule inhibitor of the PI3K/AKT/mTOR pathway, which is often abnormal and overactive in cancer, leading to faster growth of cancer cells. This drug can penetrate the blood-brain barrier, suggesting it may be a treatment for brain tumors.
Novogen licensed GDC-0084 from Genentech in October 2016, after the completion of Phase 1 clinical trials to treat advanced glioma. In scheduling its Phase 2 trial of GDC-004 to treaet gliobastoma, Novogen has consulted with several brain cancer specialists as well as top scientists, incorporating their advice into future plans for GDC-0084.
Novogen has also signed a master services agreement with Chiltern Oncology, a leading international research group that conducts trials involving new anti-cancer drugs. Novogen and Chiltern will jointly develop the upcoming Phase 2 trial for GDC-0084. The agreement encompasses key details of the proposed working relationship, but it is also open to further contractual negotiation leading up to and during the study.
Novogen has also taken steps to protect its intellectual property associated with GDC-0084. Since signing the licensing deal with Genentech, it has obtained patents for GDC-0084 in the United States, Australia, Israel and several European and Asian countries.
It will also consult with the U.S. Food and Drug Administration before beginning the study, in order to discuss what must be factored into the clinical trial design.
In addition, Novogen has obtained 48kg of GDC-0084 from Genentech. Part of that shipment has been manufactured into a batch of capsules to be used for oral administration during the clinical trial. The capsules are now undergoing routing confirmatory testing before being used for the trials.