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.
For more information, please visit: www.novogen.com
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SOURCE Novogen Limited