SYDNEY, Aug. 31, 2015 /PRNewswire/ -- US-Australian
drug discovery company, Novogen Limited (ASX: NRT; NASDAQ: NVGN)
today confirmed its comprehensive scientific review has identified
high value opportunities for its ground-breaking technology
platforms in areas of unmet patient need. Novogen is moving as
quickly as practicable through the remaining preclinical projects
prior to entering into Phase 1 clinical trials with our 3 lead
compounds.
Acting Chief Executive Officer, Iain
Ross, said that following his appointment last month,
Novogen initiated a company-wide review, including a comprehensive
science review, to determine top priorities and enabling the
Company to focus valuable resources to achieve high value
opportunities in a highly competitive market place.
"In keeping with industry best practice and Novogen's commitment
to maintaining a high standard of scientific integrity, we've
formed a Scientific Review Committee to ensure rigor is applied to
all of our decision-making processes. Committee members include
retired Executive Vice President for Eli Lilly & Co and
President of Lilly Bio-Medicines, Bryce
Carmine, as well as two eminent academic researchers:
Professor Peter Gunning from
the University of New South Wales,
Australia, and Professor Gil Mor
from Yale University in the
USA."
"I am delighted to report our Scientific Review Committee has
identified realistic opportunities based on the extensive data
available for our lead drug candidates. We have therefore chosen to
tighten our focus on significant areas of unmet patient need. Given
scientific success we are confident these opportunities will enable
us to drive strong value for shareholders," Mr Ross said.
"The Company is in a strong financial position to expeditiously
drive our three drug candidates through their final requisite
pre-clinical safety programs and ultimately into Phase 1 clinical
trials. This will be our next critical decision point. In line with
our business strategy, we will be applying our resources to target
opportunities that could generate the greatest return."
"Pending the outcome of the required safety studies we are
committed to progressing Cantrixil and Anisina to Phase 1 clinical
trials in 2016 and Trilexium by 2017. We will be continuing to work
through the necessary regulatory requirements as thoroughly and as
quickly as practicable," Mr Ross said.
"Another significant outcome of our scientific review has been
the recognition of the depth of our medicinal chemistry expertise
across our two technology platforms. This secures for the Company
exceptional future growth opportunities, provides back-ups for our
existing lead compounds and opens up new avenues for future
discovery. Our actions have also strengthened our existing patent
protection."
Mr Ross said that following the scientific review, the Company
had decided to pursue a patent protection approach for its
degenerative and regenerative medicine program known as Jacob's
Hope. This program would now take a lower profile while we focus on
the nearer term core opportunities.
PRODUCT UPDATE
Cantrixil
Cantrixil is the Company's lead superbenzopyran (SBP) drug
candidate designed to be injected into the intra-peritoneal (IP)
cavity. We aim to treat ovarian cancer by targeting both
differentiated cancer cells and potentially cancer initiating
cells, the cells thought to be responsible for cancer recurrence
post chemotherapy.
Therefore, Novogen is continuing to progress Cantrixil through
its safety evaluation program and fulfil the necessary regulatory
requirements with a view to starting Phase 1 clinical trials in
2016. As Cantrixil is a cytotoxic drug, safety signals have been
identified in the cardiovascular and gastrointestinal systems that
require further evaluation. It is important to note that the
standard treatment for ovarian cancer patients has not
significantly changed over the past 30 years and their prognosis
remains exceptionally poor with as many as 80% of these patients
suffering a relapse and ultimately an early death. Therefore an
urgent unmet clinical need remains for all ovarian cancer patients.
The Cantrixil preliminary safety observations have been discussed
with the Medical Study Committee who concur that the benefits to
ovarian cancer patients may significantly outweigh the associated
risks while on treatment.
Novogen will inform shareholders once these evaluations have
been completed. Assuming success the Company will progress to
clinical trial in Australia
focussing on late-stage ovarian cancer patients who may or may not
have associated malignant ascites using an intraperitoneal mode of
delivery.
While it is not possible at this stage to be precise as to
when clinical trials will commence, the Company continues to target
2016 to commence a first-in-human trial for Cantrixil in
Australia.
Anisina
Anisina is the Company's lead anti-tropomyosin (ATM) compound,
which is a unique first-in-class anti-cancer agent. This small ATM
molecule targets a core protein component of the actin
microfilaments, tropomyosin Tpm3.1, essential for tumor cell
survival.
The pre-clinical evidence available supports the entry of
Anisina into the regulatory required safety evaluation program.
While this program is progressing, the Company will continue to
evaluate the potential lead adult cancer indications to target in
the clinic. This evaluation will guide us towards decisions that
support a pediatric neuroblastoma program for Anisina where it has
been shown to enhance the efficacy of anti-microtubule agents when
assessed in pre-clinical models of human pediatric
neuroblastoma.
Pending a successful safety evaluation outcome, the Company
is targeting 2016 to open an all-comers Phase 1 clinical trial in
Australia, where the primary
outcome will be safety. Novogen has re-affirmed our commitment to
pediatric neuroblastoma and has assembled the relevant therapeutic
medical experts to participate on an Anisina pediatric oncology
board.
Trilexium (TRXE-009)
TRXE-009 is the Company's second lead SBP drug candidate and our
least advanced drug candidate. The Company has identified a high
value opportunity where there are currently no approved treatments
and the current life-expectancy for patients is no more than 8
months.
Through our collaboration with a local pediatric medical
oncologist, the Company has confirmed that Trilexium is exquisitely
active against patient derived explants of Diffuse Intrinsic
Pontine Glioma (DIPG) in pre-clinical studies. DIPG is an
aggressive but rare brain tumor primarily affecting children.
Novogen has identified a drug formulation that in animals is able
to deliver Trilexium to brain tissue and researchers will soon
commence a proof-of-concept pre-clinical study in an orthotropic
model of DIPG.
Once this proof-of-concept study is completed, the Company plans
to commence the required safety evaluation program. By targeting
DIPG, the Company anticipates that this strategy may provide a
fast-to-market opportunity and is also planning to file for an
Orphan Drug Designation status with the FDA. At this stage,
first-in-human trials are targeted to commence by 2017.
About Novogen
Novogen is a public, Australian-US drug development company
whose shares trade on both The Australian Securities Exchange (NRT)
and NASDAQ (NVGN). The Novogen group includes US-based, CanTx Inc.,
a joint venture company with Yale
University. Novogen has two drug technology platforms [the
superbenzopyrans (SBPs) and anti-tropomyosins (ATMs)] yielding drug
candidates that are first-in-class with potential application
across a range of degenerative diseases. Given the encouraging data
from in vitro and in vivo pre-clinical proof-of-concept studies in
the field of oncology, our immediate focus is to undertake their
respective toxicology programs. Our target indication for Cantrixil
is ovarian cancer, and Diffuse Intrinsic Pontine Glioma (DIPG) for
Trilexium. While the initial target pediatric indication for
Anisina has been identified as neuroblastoma, we are yet to
identify the adult indication and are intending to open an
all-comers Phase I trial initially based on our pre-clinical
studies. 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