SYDNEY, May 2, 2016 /PRNewswire/ -- US-Australian
drug discovery company, Novogen Limited (ASX: NRT; NASDAQ: NVGN)
today provided an update on progress regarding the development of
Cantrixil (TRXE-002-1), its lead superbenzopyran (SBP) molecule,
which is intended for the treatment of ovarian cancer.
Cantrixil remains on track to commence clinical trials in the
second half of 2016, as the Company has previously indicated. The
proposed design of the phase I study has been amended in light of
emerging data to focus more specifically on patients with ovarian
cancer in order to better understand its effects in the target
population, and it is no longer anticipated to be restricted to
patients with malignant ascites. It is envisaged that the study
will be conducted at centres in Australia and the
United States, and discussions are ongoing with potential
clinical investigators in both countries.
Given the international scope of the study, Quintiles (NYSE: Q),
a global clinical research organisation (CRO), has been engaged to
support execution of the study. Novogen plans to submit an
Investigational New Drug (IND) application to the United States
Food and Drug Administration (FDA) in August
2016, and expects to achieve First Patient In (FPI) to the
study in the fourth quarter of 2016.
In preparation for transition of Cantrixil into the clinic,
Novogen has concluded funding to the CanTx joint venture with
Yale University, and the CanTx entity
will be wound-up in an appropriate manner. All intellectual
property licensed from Novogen to CanTx will be returned to
Novogen, in accordance with the terms of the agreement between the
two companies.
CanTx was formed in November 2013
as a joint venture between Novogen, Yale
University, and certain of its faculty, with Novogen owning
85% of the company. The primary purpose of the joint venture was to
facilitate the application of Yale's
experimental models and preclinical test systems to Novogen's
molecules. Novogen licensed components of its intellectual property
to CanTx for investigation in the laboratories of Professor
Gil Mor, and this work has provided
useful data to guide further development of Cantrixil, Novogen's
lead superbenzopyran molecule, in the field of ovarian cancer.
A scientific review by Novogen's Board in August 2015 resolved to advance Cantrixil into
clinical development in this indication, and the Company's R&D
team have since been focused on designing and implementing an
appropriate first-in-human study.
Dr James Garner, CEO of Novogen,
said, "CanTx has been a helpful vehicle for performing some of the
supportive experiments that have informed our development of
Cantrixil. As we move into clinical trials, a simpler arrangement
will be advantageous and we will be returning the licensed
intellectual property to Novogen's stewardship. We believe this
represents the most appropriate use of shareholder funds, and the
most effective way to move Cantrixil forward."
As part of the wind-up process, Novogen may be required to
recognise an impairment to certain inter-company loans between
Novogen and CanTx, and these impairments will be appropriately
reported once they have been fully determined.
Dr Garner added, "We believe there is a strong basis to move
Cantrixil into the clinic and the team has been working assiduously
for some months on the necessary preparations. We have completed
most of the IND-enabling work, and are finalising protocol design
in collaboration with external advisors and potential
investigators, while also completing manufacture of the
investigational product. Our goal is to offer a meaningful new
treatment option for patients with ovarian cancer, and we plan to
give Cantrixil the best opportunity possible to demonstrate its
potential in a clinical setting."
About the Cantrixil (TRXE-002-1) drug candidate
Cantrixil is a cyclodextrin-based formulation of the active
ingredient, TRXE-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 cavity (eg ovarian, uterine, colorectal and gastric
carcinomas). A first-in-human clinical study is planned to commence
in the second half of 2016.
About Novogen Limited
Novogen is an oncology-focused, Australian-US drug development
company, traded on both the Australian Securities Exchange (NRT)
and on NASDAQ (NVGN). Novogen has two proprietary drug discovery
platforms, the superbenzopyrans (SBPs) and the anti-tropomyosins
(ATMs), which have provided first-in-class agents with potential
application across a range of oncology indications. The Company has
three lead molecules Cantrixil, Anisina, and Trilexium, which are
in advanced preclinical development for various cancer types, with
the most advanced molecule, Cantrixil, slated to enter clinical
trials in the second half of 2016. For more information, please
visit www.novogen.com.
Forward Looking Statement
This press release contains "forward-looking statements"
within the meaning of section 27A of the Securities Act of 1933 and
section 21E of the Securities Exchange Act of 1934. The Company has
tried to identify such forward-looking statements by use of such
words as "expects," "appear," "intends," "hopes," "anticipates,"
"believes," "could," "should," "would," "may," "target,"
"evidences" and "estimates," and other similar expressions, but
these words are not the exclusive means of identifying such
statements. Such statements include, but are not limited to any
statements relating to the Company's drug development program,
including, but not limited to the initiation, progress and outcomes
of clinical trials of the Company's drug development program,
including, but not limited to Cantrixil, Anisina, Trilexium, and
any other statements that are not historical facts. Such statements
involve risks and uncertainties, including, but not limited to,
those risks and uncertainties relating to the difficulties or
delays in financing, development, testing, regulatory approval,
production and marketing of the Company's drug components,
including, but not limited to, Cantrixil, Anisina, Trilexium, the
ability of the Company to procure additional future sources of
financing, unexpected adverse side effects or inadequate
therapeutic efficacy of the Company's drug compounds, including,
but not limited to, Cantrixil, Anisina, Trilexium, that could slow
or prevent products coming to market, the uncertainty of patent
protection for the Company's intellectual property or trade
secrets, including, but not limited to, the intellectual property
relating to Cantrixil, Anisina, Trilexium, and other risks detailed
from time to time in the filings the Company makes with Securities
and Exchange Commission including its annual reports on Form 20-F
and its reports on Form 6-K. Such statements are based on
management's current expectations, but actual results may differ
materially due to various factions including those risks and
uncertainties mentioned or referred to in this press release.
Accordingly, you should not rely on those forward-looking
statements as a prediction of actual future results.
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SOURCE Novogen Ltd