SYDNEY, Aug. 11, 2016
/PRNewswire/ -- Australian oncology-focused biotechnology
company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that
it has submitted an Investigational New Drug (IND) application to
the United States Food and Drug Administration (FDA) for Cantrixil
(TRX-E-002-1) in ovarian cancer.
The IND is a detailed regulatory filing which is required to
initiate clinical studies in the United
States. It has been compiled over the past twelve months,
following a decision to move Cantrixil into clinical development at
the Company's strategic pipeline review in August 2015.
The IND submission includes a comprehensive package of data,
encompassing preclinical pharmacology and toxicity, manufacturing,
quality control and clinical development plans. Novogen will be
able to move forward to the next step of setting up the clinical
trials program thirty days after submission, unless FDA reviewers
have questions or concerns which cannot be resolved during that
time.
Dr Kimberley Lilischkis, Director
of Clinical & Regulatory Affairs at Novogen, commented,
"The Cantrixil IND is a critical
step on the path to the clinic. We will work closely with the FDA
to resolve any queries they may have. Following that, we expect to
initiate the study swiftly in the last quarter of 2016, with
participation from centres in the US and Australia."
Cantrixil is a first-in-class development candidate which is
being studied as a therapy for ovarian cancer, administered
directly into the abdominal cavity via the intra-peritoneal route.
Preclinical data has shown broad-based evidence of anti-tumour
activity in animal models of ovarian cancer,[1] and a toxicology
program conducted under GLP (Good Laboratory Practice (GLP) has
demonstrated a toxicity profile that appears appropriate for use in
humans at therapeutic doses.[2]
Dr James Garner, CEO of Novogen,
added, "This is an important
milestone in Novogen's transition to a clinical stage drug
development company. I am delighted that the team has succeeded in
delivering on schedule, in accordance with our prior guidance of an
August 2016 submission. The Cantrixil
trial has received strong interest from clinicians in Australia and the
United States. The team is working with Quintiles, our
contract research organisation, to select and initiate the most
appropriate trial sites and prepare for the phase I study."
About the Cantrixil (TRX-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 tumour 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 is planned to commence in the fourth
quarter of 2016.
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an oncology-focused
biotechnology company based in Sydney,
Australia. 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, with the most advanced
molecule, Cantrixil, slated to enter clinical trials in late 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.
[1] AB Alvero, A Heaton, E
Lima, et al. (2016). Molecular Cancer
Therapeutics, 15(6):1279-90 (June
2016)
[2] K Lilischkis, A Heaton, A Alvero, et al. (2016).
Abstract LB201, Annual Meeting of the American Association of
Cancer Research (New Orleans,
LA)
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SOURCE Novogen Ltd