SYDNEY, Aug. 7, 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
development candidate, Cantrixil (TRXE-002-1).
Phase I Clinical Trial in Ovarian Cancer Progressing to Plan
Novogen commenced a phase I clinical trial of Cantrixil in
ovarian cancer in December 2016. The
study is primarily designed to understand the safety profile of
Cantrixil in human subjects, and to establish a Maximum Tolerated
Dose (MTD) for the drug.
In accordance with common practice for phase I studies, patients
will initially be administered very low doses of Cantrixil, with
doses carefully escalated in subsequent patients under careful
monitoring by clinicians according to safety and tolerability
criteria. Once the MTD has been established, the study will expand
recruitment to additional patients in order to further establish
safety and explore signals of clinical efficacy.
As at 1st August, the Cantrixil study had
successfully progressed through a number of dose levels and
participating patients were being carefully monitored for safety.
The study continues to recruit patients under the oversight of the
investigating clinicians.
Five hospitals are participating in the study, and all sites are
open to recruitment, after approval by their respective Human
Research Ethics Committees. The participating sites are listed
below.
Site
|
State
|
Country
|
Westmead
Hospital
|
NSW
|
Australia
|
Flinders Medical
Centre
|
SA
|
Australia
|
ICON Cancer
Care
|
QLD
|
Australia
|
Peggy & Charles
Stephenson Cancer Center
|
Oklahoma
|
USA
|
Mary Crowley Cancer
Research Center
|
Texas
|
USA
|
A sixth hospital had originally planned to participate, but
withdrew from the study as the clinician due to oversee the trial
moved to a different role with another hospital. The withdrawal is
not anticipated to have any material impact on the study
timeline.
The duration of the study will depend on how many times the dose
levels can be escalated before the MTD is established. A higher MTD
will result in a longer study, but typically implies a better
tolerated drug. Based on the current study progress, Novogen
anticipates that it will be able to report the MTD in the first
quarter of calendar 2018. It is anticipated that exploratory
efficacy data from the additional patients will be available later
in calendar 2018.
Novogen CEO, Dr James Garner,
commented, "We are pleased with progress to date in the phase I
study of Cantrixil. Novogen is fortunate to be working with
highly-experienced clinicians at leading trial centers. We remain
excited by the potential for Cantrixil to become an important
addition to the treatment landscape in ovarian cancer and are
grateful to those patients who are participating in the study."
Novogen looks forward to sharing additional progress reports
with investors periodically as the study advances.
Manufacturing
To support continued conduct of the phase I clinical trial in
ovarian cancer, Novogen is in the process of engaging a Contract
Manufacturing Organization to produce a second batch of clinical
trial material under Good Manufacturing Practice conditions. This
material will be used to ensure uninterrupted supply to clinical
trial sites as the study progresses.
Intellectual Property
The intellectual property portfolio around Cantrixil has been
strengthened with the granting of two new patents.
The patent covering Cantrixil has proceeded to grant in
the United States on 11 July 2017. In addition, the patent covering
Cantrixil has also proceed to grant in the European Union on
2 August 2017. These are important
milestones for Cantrixil as they serve to protect the intellectual
property associated with the molecule in the world's largest two
markets.
Novogen has applied for patent protection in a total of 25
jurisdictions worldwide, and these applications continue to move
forward according to each authority's specific process.
About the Cantrixil (TRXE-E-002-1) development
candidate
Cantrixil is a cyclodextrin-based formulation of the active
ingredient, TRX-E-002-1, which has shown in vitro and in
vivo anti-cancer activity in a range of tumor types. The
Company anticipates that, if approved, the drug product would be
used as an intra-peritoneal chemotherapy, either alone or in
combination with other agents, and in one or more cancers of the
abdominal or pelvic cavity (e.g. ovarian, uterine, colorectal or
gastric carcinomas). A first-in-human clinical study in patients
with ovarian cancer is currently underway.
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, TRXE-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