SYDNEY, June 14, 2016
/PRNewswire/ -- US-Australian drug discovery company Novogen Ltd
(ASX: NRT; NASDAQ: NVGN) today announced that a patent for the
ATM-3500 series had been granted in Australia. The ATM-3500 series includes the
investigational agent known as Anisina (ATM-3507).
Novogen North America CEO, Dr Andrew
Heaton, commented: "This patent provides full protection for
Anisina in Australia through to
2035. Together with the SBP patent that was granted in February,
today's news means that all three of Novogen's development
candidates -- Cantrixil, Anisina and Trilexium -- are
fully covered in Australia. With
our strategy of utilizing the extensive global patent superhighway
convention we anticipate a very smooth roll out of these patents
globally."
Anisina is the first of a novel class of investigational
anti-cancer agents known as anti-tropomyosins (ATMs), which
selectively target an essential structural component of the cancer
cell, causing cell death and tumor reduction in experimental
models.
Dr Justine Stehn, Program
Director for the ATM program, added: "The granting of this patent
reflects the innovation inherent in the ATM technology, and gives
us confidence to continue moving forward towards clinical
trials."
IND-enabling activities for Anisina are currently underway, with
the intent of initiating clinical trials in 2017. Manufacture of
API (Active Pharmaceutical Ingredient) in accordance with GMP (Good
Manufacturing Practice) is in progress, and a battery of tests,
including stability, sterility, and other parameters, will be
undertaken after this is complete, in accordance with regulatory
requirements.
In parallel, the company is performing a standard range of
mandated GLP (Good Laboratory Practice) toxicology studies so as to
establish the safe dosing range for clinical studies. Preclinical
work remains ongoing to fully characterize the effects of the drug
and to establish the most appropriate population for a phase I
clinical trial.
About the Anisina (ATM-3507) drug candidate
Anisina (ATM-3507) is the first drug candidate in the Company's
anti-tropomyosin (ATM) program. Based on initial research at the
University of New South Wales (UNSW),
the ATM family have been developed through a rational drug design
program to target the Tpm3.1 protein, a critical structural
component of cancer cells. Anisina has been shown to be effective
in vitro and in vivo against a broad range of cancer
types, including neuroblastoma and prostate cancer. The drug is
currently undergoing IND-enabling toxicology studies in preparation
for the initiation of clinical trials.
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 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
(e.g. ovarian, uterine, colorectal and gastric carcinomas). A
first-in-human clinical study is planned to commence in the second
half of 2016.
About the Trilexium (TRXE-009) drug candidate
Trilexium (TRXE-009) is the Company's second SBP drug candidate.
It has shown evidence of potent anti-cancer activity across a wide
range of tumor types, and additional preclinical work is underway
to further characterize the drug's activity, and to identify
potential indication(s) for clinical development.
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 (superbenzopyrans and anti-tropomyosins) with the
potential to yield first-in-class agents across a range of oncology
indications. The three lead molecules Cantrixil, Anisina, and
Trilexium are in preclinical development for various cancer types,
with the most advanced molecule, Cantrixil, slated to enter
clinical trials in late 2016. For more information, please visit
www.novogen.com.
™ Trademark of Novogen Limited
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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/novogen-patent-covering-anisinatm-has-proceeded-to-grant-300284023.html
SOURCE Novogen Ltd