SYDNEY, Nov. 24, 2015 /PRNewswire/ --
- Novogen engages Novotech as CRO for upcoming Phase 1
clinical study
- Cantrixil Phase 1 clinical trial to be conducted in patients
with refractory/recurrent peritoneal malignancies with malignant
ascites, including ovarian cancer
US-Australian drug discovery company, Novogen Limited (ASX:NRT:
NASDAQ: NVGN), announced today that it has engaged Novotech as the
Contract Research Organisation (CRO) to conduct its Phase 1
clinical study for the drug candidate, Cantrixil, which will
commence in 2016.
This first-in-human study will investigate the safety and
feasibility of Cantrixil administered via the intraperitoneal route
for patients with refractory /recurrent peritoneal malignancies
with malignant ascites.
According to Novogen's Clinical and Regulatory Affairs Manager,
Kimberley Lilischkis, PhD, the
Cantrixil Phase 1 study will be weighted towards ovarian cancer
patients with the selection of a gynecological oncology site.
"However, patients with other cancer types will also be
eligible to enrol in this first study since early preclinical data
suggests the drug candidate may benefit patients with a range of
cancer types," Dr Lilischkis said.
"Patients with malignant ascites have been chosen because
ethically this patient group stands to receive the most benefit and
face the least risk from the insertion of a peritoneal port or
catheter, which can be used for drug administration but also for
the on-going drainage of malignant ascites."
Dr Lilischkis said Novogen was continuing to progress Cantrixil
through the necessary preclinical regulatory requirements and
safety evaluations and was on track to complete the 'in-life' phase
of the toxicity studies by the end of 2015. The Company expected to
receive the final report in early 2016 once a comprehensive
pathology review was completed.
Acting CEO, Iain Ross said the
appointment of Novotech was a key milestone in progressing
Novogen's first oncology drug candidate, Cantrixil, to the clinic.
"Novogen is confident that Novotech will add significant value to
the clinical trial program bringing their standard of excellence to
the development of this promising drug candidate," Mr Ross
said.
Novotech is a prominent Australian-based CRO with extensive
background in oncology drug development and a broad range of
clinical trial outsourcing services. Novotech has well-established
working relationships with the Australian sites and KOLs working
with Novogen on this study. This CRO has world-class electronic
data and trial management systems that will support the data
management, monitoring and safety reporting activities for this
study. Novotech is the only Australian-based CRO that has a Quality
Assurance system with ISO9001:2008 accreditation and has a superb
track record in managing early phase oncology studies.
"We're delighted to be working with Novogen on this important
study. The development of Cantrixil has the potential to add an
important new tool in the fight against cancer, and we are looking
forward to leveraging our previous experience in all phases of
oncology drug development to the management of this program," CEO
of Novotech, Alek Safarian,
said.
About the Cantrixil drug candidate
The candidate Cantrixil drug product is cyclodextrin-based
containing the active ingredient, TRXE-002-1. The Company
anticipates that if approved the drug product would be used as an
intra-cavity chemotherapy to be injected directly into the
peritoneal cavity. The aim of intraperitoneal administration is to
achieve high localized drug levels within the peritoneal cavity and
attenuate the spread of resident tumor initiator cells. The target
indication sought for Cantrixil is early-stage cancers of the
abdominal cavity (eg. ovarian, uterine, colorectal and gastric
carcinomas) with Cantrixil being used as an adjuvant first-line
therapy. On completion of the requisite safety studies, Cantrixil
will enter the clinic in late-stage patients with abdominal cancers
including ovarian cancer. The active pharmaceutical ingredient,
TRXE-002, has pan anti-cancer activity resulting in
caspase-dependent apoptosis via c-Jun activation and pERK
downregulation. The actual drug target remains unidentified.
About Novogen Limited
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 preclinical
proof-of-concept studies in the field of oncology, the Company's
immediate focus is to undertake the respective toxicology programs.
The 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, Novogen is yet to identify the adult indication and
is intending to open an all-comers Phase 1 trial initially based on
its preclinical 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, 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, 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, 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,
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