GDC-0084 Progress Update: On Track for Phase II Commencement in 2017

2017-08-22 12:06 2029

SYDNEY, Aug. 22, 2017 /PRNewswire/ -- Novogen Ltd (ASX: NRT; NASDAQ: NVGN), an Australian oncology drug development company, is pleased to provide an update to investors on progress with its clinical-stage drug development candidate, GDC-0084. GDC-0084 was in-licensed from Genentech, Inc in October 2016, after completion of a phase I clinical trial in advanced glioma.

Key Highlights

  • Phase II clinical trial on track to commence in fourth quarter of calendar 2017
  • Master Services Agreement signed with Chiltern Oncology, a leading international contract research organization, in relation to conduct of the phase ll development program
  • Patents granted in five territories, including USA and Australia, since licensing from Genentech

Novogen CEO, Dr James Garner, commented on recent progress, "The GDC-0084 study is on track to commence this year, in line with our prior guidance to the market. 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."

Phase II Clinical Trial in Glioblastoma On Track

Novogen previously announced its intent to commence a phase II clinical trial of GDC-0084 prior to the end of calendar 2017, and remains on track to fulfil this objective. It is expected that the trial will commence in the fourth quarter.

The Company has benefited greatly from the advice and input of several specialist clinicians in the United States with expertise in brain cancer, and also from the guidance of its Scientific Advisory Board.

Contract Research Organization Engaged

Novogen has signed a Master Services Agreement (MSA) with Chiltern Oncology in relation to conduct of the phase II clinical trial of GDC-0084. Chiltern Oncology is a leading international contract research organization, with a specialist capability in trials of novel anti-cancer agents. The MSA details key terms of the proposed working relationship, but implementation of the study will be subject to further contractual negotiations.

Intellectual Property Secured

As part of the license agreement with Genentech, Novogen assumed responsibility for protection of intellectual property associated with GDC-0084. Since taking over this responsibility, Novogen has successfully secured patents in several jurisdictions, including the United States, Australia, and Israel, as well as key countries in Asia and Eurasia.

Next steps

Clinical trial design: Consultation with FDA expected to occur prior to initiation of the study to discuss key features of the clinical trial design.

Manufacturing: Novogen acquired approximately 48kg of drug substance as part of the transaction with Genentech, and part of this has now been manufactured into an initial batch of capsules for oral administration in the clinical trial. This material is now undergoing routine confirmatory testing before being released for use.

Novogen looks forward to sharing additional progress reports with investors periodically as the study advances.

About the GDC-0084 development candidate

GDC-0084 is a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is distinguished from other molecules in the class by its ability to penetrate the blood-brain barrier. PI3K inhibitors have shown evidence of clinical activity in a broad range of tumor types, and one product in the class has reached market for several hematological malignancies. GDC-0084 was developed by Genentech, who completed a phase I study in patients with recurrent glioma, and was licensed to Novogen in October 2016.  A phase II clinical trial is slated to begin in the fourth quarter of calendar 2017.

About Novogen Limited

Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an emerging oncology-focused biotechnology company, based in Sydney, Australia. Novogen has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best- in-class agents in a range of oncology indications.

The lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme. Licensed from Genentech in late 2016, GDC-0084 is anticipated to enter phase II clinical trials in 2017. A second clinical program, TRX-E-002-01 (Cantrixil) commenced a phase I clinical trial in ovarian cancer in December 2016. In addition, the company has several preclinical programs in active development, the largest of which is substantially funded by a CRC-P grant from the Australian Federal Government.

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Source: Novogen Limited
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