SYDNEY, Dec. 16, 2014
/PRNewswire/ -- Novogen Limited (ASX:NRT;
NASDAQ:NVGN), Australian/US
biotechnology company, today
announces that it has confirmed that its lead candidate product,
TRXE-009, originally developed for the treatment of brain cancers,
has been shown in pre-clinical studies also to be highly active
against melanoma.
The Company believes this is an important breakthrough discovery
for two reasons. The first is that it confirms that TRXE-009 is an
important new potential treatment for melanoma, including for the
treatment of secondary brain cancers due to melanoma, for which
there currently are no effective therapies. The second is that it
offers evidence for the first time of an hypothesized link between
brain cancer and melanoma.
The link has long been considered a possibility because nerve
cells and melanocytes (the melanin pigment-bearing cells in skin
that lead to melanoma) have a common origin in the embryo known as
the neural crest. This primitive tissue gives rise to the neural
cells that go on to form the brain, spinal cord, and peripheral
nerves, as well as cells that form the structures of the skull;
melanocytes also come from this embryonic tissue. Up till now, no
functional link has been found between brain cells and melanocytes,
or between brain cancer and melanoma. TRXE-009 is the first
compound to demonstrate the possibility of a common link,
suggesting that is the first drug with the ability to identify
cancers arising in cells that have the neural crest as their common
origin.
TRXE-009 has been confirmed as a potential new treatment for
both adult and paediatric neural cancers. TRXE-009 previously has
been announced as a world-first in having exceptionally high
killing activity against adult brain cancer (glioblastoma
multiforme) stem cells, and against the paediatric brain cancers -
medulloblastoma and DIPG (diffuse interstitial pontine glioma) -
all tumors that are highly resistant to known chemotherapies. That
same high potency is now confirmed against melanoma cells, with
activity unaffected by the tumor's BRAF gene status.
Dr Graham Kelly, Novogen Group
CEO, said, "This latest finding brings the value of TRXE-009 into
true perspective for us. We initially developed the compound for
brain cancer. We saw it as the first chemotherapy with the
potential to make a meaningful difference to the survival prospects
of patients, both adult and children, with primary brain
cancer."
"From there we looked at its ability to kill other cancers of
neural origin, and discovered that the same potency against brain
cancer cells extended to neuroblastoma cells, a potential deadly
cancer in children that arises in peripheral nerve tissue outside
of the brain."
"With the realisation that we arguably had the first anti-cancer
drug capable of recognising cancers arising in tissues with a
common neural crest origin, it was an obvious next step to look at
melanoma, with the outcome that we are announcing today," Kelly
explained.
Novogen will be delivering TRXE-009 as a proprietary construct
known as Trilexium. Trilexium has been developed to maximise the
bio-availability of the drug to cancer cells in the body. Animal
xenograft studies of human cancer have confirmed the efficacy of
Trilexium.
Kelly said, "This finding completely changes the outlook for
this drug candidate. From a drug that was due to come into the
clinic specifically for the treatment of adult and childhood neural
cancers, we now are presented with a prospective treatment for
malignant melanoma, including the treatment of secondary brain
cancers due to melanoma for which there currently is no effective
therapy."
"We naturally are keen to bring Trilexium into the clinic as
soon as possible," said Kelly. "But
our entire focus at the moment in terms of a clinical program is
the product candidate, Cantrixil. That is where our efforts are
centred and where our current financial resources are committed,
with the objective of achieving the key inflection point of
transiting into a clinical-stage company as a firm strategy.
Trilexium will enter the clinic only when we have been successful
in raising funds specifically ear-marked for this project. Those
discussions are current with interested stakeholders."
About Novogen Limited
Novogen is a public, Australian 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, including the cancer stem cells. The
molecular target is a trans-membrane electron-transfer pump
mechanism oncogene that is common to all cancer cells. Cells die by
respiratory distress and mitochondrial disintegration.
The ATM compounds target the micro-filament component of the
cancer cell's cytoskeleton and have been designed to combine with
anti-microtubular drugs (taxanes, vinca alakaloids) to produce
comprehensive and fatal destruction of the cancer cell
cytoskeleton.
The Company pipeline comprises three SBP drug candidates
(TRXE-002, TRXE-009, TRXE-0025) and one ATM drug candidate
('Anisina').
About TRXE-009
TRXE-009 is an SBP compound generated by the Company's VAL-ID
(Versatile Approach to Library-based Iterative Design) drug
discovery process, with structure-activity relationship driving
design based on activity against brain cancer stem cells and the
known required chemical criteria to facilitate passage across the
blood-brain barrier.
About Trilexium
Trilexium is a construct of drug candidate, TRXE-009, in a
proprietary oil-based formulation selected for its ability to
maximize passage of drug across the cancer cell plasma
membrane.
About Melanoma
Malignant melanoma (Stage 4), where the cancer has spread away
from the site of origin, remains a major unmet clinical need with
limited effective treatment options. Main sites of metastasis are
lungs, liver, brain, bones, and distant lymph nodes and skin.
Immunotherapies (ipilumumab, vemurafenib, vaccines), chemotherapy
(dacarbazine, vinblastine), radiotherapy and surgery are used to
prolong life in Stage 4 disease, but these modalities provide
little benefit where metastases has occurred to the brain.
Further information is available on our websites
www.novogen.com
For more information please contact:
Corporate Contact
Dr. Graham Kelly
Executive Chairman & CEO Novogen Group
Graham.Kelly@novogen.com
+61-2-9472-4100
Media Enquiries
Cristyn Humphreys
Operations Manager Novogen Group
Cristyn.Humphreys@novogen.com
+61-2-9472-4111
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SOURCE Novogen Ltd