Novogen Encouraged by FDA for Phase II Study

KEY TAKEAWAYS:

• Novogen is set to take GDC-0084 into phase II clinical trial in the treatment of GBM.
• A clinical development plan proposal drafted by Novogen for GDC-0084 in those adult patients with GBM has been discussed in a Type B meeting held between Novogen Limited and the FDA.
• Novogen has elected to incorporate a lead-in component in the planned phase II study.

Following the successful completion of phase I of GDC-0084 in a clinical trial in advanced glioma, Novogen is set to take GDC-0084 into phase II clinical trial in the treatment of GBM (glioblastoma multiforme). The Phase I completion saw GDC-0084 in-licensed from Genentech, Inc during October 2016.

Presently, the company has signed a Letter of Intent (LOI) with the Chiltern Oncology, providing for the initiation of the set-up activities for the study. This comes a month later after Novogen declared having entered into a Master Services Agreement (MSA) with the Chiltern Oncology. Chiltern Oncology is a renowned foremost international Contract Research Organization (CRO).

GDC-0084, a candidate, developed by Genentech and licensed to Novogen in October 2016, is a minute molecule inhibitor, primarily of the P13K/AKT/mTOR pathway identified by its unique ability to infiltrate the blood-brain barrier.

All the patients subjected to the phase I study overseen by Genentech showed progress during or after the treatment with not less than one previous line of therapy. These patients had high-grade gliomas including glioblastoma.

A clinical development plan proposal drafted by Novogen for GDC-0084 in those adult patients with GBM was discussed in a Type B meeting held between Novogen Limited and the FDA on 21st September in Maryland at the FDA’s Center for Drug Evaluation and Research. Fortunately, the major design features of the study won’t be changed with the study scheduled to begin by the end of 2017.

Dr James Garner, Novogen CEO, stated, “We are grateful to FDA for their careful evaluation and considered advice and we are encouraged by their engagement with the program. The study remains on track for commencement by the end of calendar 2017, and we are confident that our approach is optimized for success.”

Novogen intends to effectively use the dosing in the planned patient population. To achieve this, it has elected to incorporate a lead-in component in the planned phase II study following a consultation with its clinician advisors.

To help de-risk the overall phase II program, a staged approach including a lead-in component has been considered. Furthermore, this approach will offer a preliminary data read-out after about 12-15 months of inception.

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