SYDNEY, March 16, 2016 /PRNewswire/ -- US-Australian
drug discovery company, Novogen Limited (ASX:NRT; NASDAQ:NVGN)
today announced that it has received a cash refund of $2.8M from the Australian Taxation Office under
the R&D Tax Incentive Program for the financial year ending
30 June 2015. This will support the
Company's preparations to progress Cantrixil (TRXE-002-1), its lead
superbenzopyran (SBP) drug candidate, to Phase 1 clinical trial in
2016.
According to Novogen CEO, Dr James
Garner, it was expected that the Company would continue to
comply with the internationally competitive Australian Government
tax incentive scheme and receive commensurate cash benefits in
future years, enabling Novogen to continue to reinvest in early
stage drug initiatives and product development opportunities.
"These funds reinforce the Company's strong financial position
as we move towards commencing a Phase 1 clinical trial for
Cantrixil in the second half of 2016," Dr Garner said.
"We have completed the necessary GLP toxicology program on
Cantrixil to enable a first-in-human study. The final results of
that program have been accepted for presentation at the Annual
Meeting of the American Association for Cancer Research (AACR) in
April 2016. The accepted abstract
will be available to view on the Novogen and AACR websites on
15 April 2016. We have also completed
large-scale GMP manufacture of the API and the production of
sterile drug product for clinical studies is well advanced. The
Company continues to expect that these data provide a sound basis
to move forward into the clinic. We are currently working with
experienced clinicians and expert consultants to finalise the study
design," he added.
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 (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 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