SYDNEY, April 17, 2015
/PRNewswire/ -- US-Australian drug discovery company, Novogen,
today announced that it had signed a Memorandum of Understanding
with the Feinstein Institute for Medical Research ('Feinstein
Institute') of New York to
collaborate with the objective of developing effective treatments
for brain cancers.
The collaboration brings together the drug discovery expertise
of Novogen and the preclinical and clinical expertise of the
Feinstein Institute in neurosciences and oncology.
At the heart of the collaboration is the Company's
super-benzopyran (SBP) drug technology platform, distinguished by
its ability to kill the full spectrum of cells within a tumor
including both rapidly- and slowly-dividing cancer cells
(tumor-initiating cells).
The three key areas of research will be:
- the development of lead SBP drug candidate, TRXE-009, as a
treatment of both primary and secondary brain cancer in adults and
children, including glioblastoma and medulloblastoma;
- the potential ability of the SBP technology (based on early
evidence) to deliver an entirely novel approach to chemotherapy by
converting cancer stem cells into stem cells displaying normal stem
cell behaviour; and
- the development of drug candidates as radio-sensitizers
designed to augment the effectiveness of radiotherapy in treating
brain cancers.
TRXE-009 (Trilexium) is a pan-acting (across all forms of
cancer) anti-cancer cytotoxic molecule that is on track to enter
the clinic in early-2016 for the treatment of solid and non-solid
cancers. A particularly high activity against melanoma cells has
been announced previously and malignant melanoma is expected to be
a key clinical indication to be pursued. For this purpose, TRXE-009
will be delivered systemically in a way that the Company has
confirmed in animal studies delivers the drug in a bio-available
form in the bloodstream that delivers a potent anti-tumor effect on
tumors growing outside of the brain. The task now remains to
confirm that TRXE-009 can be delivered to brain cancer tissue in
adequate amounts.
TRXE-009 has proven to be particularly effective in vitro
against adult (glioblastoma) and paediatric (diffuse intrinsic
pontine glioma; medulloblastoma) brain cancer cells, marking it as
a unique and highly promising drug candidate for the treatment of
these cancers. The collaboration announced today is focused
specifically on these tumors and the need to optimize the delivery
of TRXE-009 to cancerous tissue within the brain.
Novogen CEO Graham Kelly, PhD,
said today, "We are confident that we have found the drug that can
successfully treat cancers arising in the brain as well as cancers
that spread to the brain from elsewhere. The ability of TRXE-009 to
kill brain cancer stem-like cells gives us particular confidence
that we can finally kill off the root cause of any cancer within
the brain.
"The proviso is that we can deliver it across the blood-brain
barrier, and that is something that we will not know with any
certainty until we bring TRXE-009 into the clinic. The
collaboration with the Feinstein Institute is designed to maximize
that likelihood. If we can do that, then we have a good chance of
delivering breakthrough treatment options to adults and children
with primary brain cancers and for patients with cancers such as
melanoma that involve the brain and elsewhere," added Kelly.
Using models developed in the laboratory by the Feinstein
Institute, the ability of TRXE-009 to treat various forms of human
brain cancer will be studied using a variety of new approaches,
such as direct micro-injection into the brain (convection enhanced
delivery) and intravenous administration with a range of constructs
known to facilitate the transport of drugs across the blood-brain
barrier, some of which have been developed by Novogen chemists.
"This collaboration between the Feinstein Institute and Novogen
is critical to supporting the discovery of new treatments for
patients who suffer from life-threatening brain cancer," said
John A. Boockvar, MD, who co-directs
the Feinstein Institute's Brain Tumor Biotech Center with
Marc Symons, PhD.
"Patients who suffer from brain cancer don't have optimal
therapies to turn to. By offering them new, improved treatments, we
will give hope to patients who face a devastating disease."
About Super-Benzopyrans and TRXE-009
Super-benzopyrans (SBPs) are small molecules based on an
expanded benzopyran molecular structure. They display pleiotropic
biological properties involving both pro-survival and pro-death
functions based on particular structural properties. TRXE-009 has
been selected for its cytotoxicity against cancer cells. The
mechanism of action is not fully elucidated and multiple molecular
targets are thought to be involved, including gene transcription
factors. Inhibition of ion exchange mechanisms leading to loss of
trans-membrane potential is a known target.
About The Feinstein Institute for Medical Research
Headquartered in Manhasset, NY,
The Feinstein Institute for Medical Research is home to
international scientific leaders in many areas including cancer,
Parkinson's disease, Alzheimer's disease, psychiatric disorders,
rheumatoid arthritis, lupus, sepsis, human genetics, pulmonary
hypertension, leukemia, neuroimmunology, and medicinal chemistry.
The Feinstein Institute, part of the North Shore-LIJ Health System,
ranks in the top 6th percentile of all National Institutes of
Health grants awarded to research centers. For more information,
visit www.FeinsteinInstitute.org.
About brain cancers
Cancers of the brain can be divided into those that originate
within the brain (primary brain cancers) and those that originate
outside of the brain (secondary or metastatic brain cancers); lung
cancer and melanoma are common causes of secondary brain cancers.
The most common type of primary brain cancer in adults is
glioblastoma and in children is medulloblastoma. Treatment options
involve surgery, radiotherapy and chemotherapy. Chemotherapy
options are limited by two main factors: (1) the poor sensitivity
of brain cancer cells to chemotherapy drugs; and (2) the difficulty
of transporting drugs to the brain across the blood-brain barrier.
Only 1 in 5 adults diagnosed with malignant brain cancer will
survive for at least 5 years. In the US and Australia, survival rates have improved less
than 2% over the past 30 years.
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 main drug technology platforms:
super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP
compounds have been designed to kill the full heterogeneity of
cells within a tumor, but with particular activity against the
cancer stem (tumor-initiating) cell.
The ATM compounds target the micro-filament component of the
cancer cell's cytoskeleton and have been designed to combine with
anti-microtubule drugs (taxanes, vinca alkaloids) to produce
comprehensive and fatal destruction of the cancer cell
cytoskeleton.
The Company pipeline comprises two SBP drug candidates
(TRXE-002, TRXE-009) and one ATM drug candidate
(Anisina).
Further information is available on our website
www.novogen.com.
For more information please contact:
Corporate
Contact
Dr. Graham
Kelly
Executive Chairman
& CEO
Novogen
Group
Graham.Kelly@novogen.com
+61 (0) 2 9472
4100
|
Media
Enquiries
Cristyn
Humphreys
Chief Operating
Officer
Novogen
Group
Cristyn.Humphreys@novogen.com
+61 (0) 2 9472
4111
|
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, TRXE-009, 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 TRXE-009, 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,
TRXE-009, 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 TRXE-009, 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