SYDNEY, March 4, 2015 /PRNewswire/ -- Australian/US
biotechnology company, Novogen Limited (ASX:NRT; NASDAQ:NVGN), today
announces that it has confirmed that one of its lead candidate
products, TRXE-009, is showing the potential to become an important
new therapy in the fight against adult and pediatric brain
cancer.
The latest study looked at the ability of TRXE-009 to kill a
library of patient-derived cell cultures from subjects with
glioblastoma multiform (GBM). The cells were cultured under
conditions that promote cancer stem cell growth. These stem-like
cancer cells are believed to be responsible for chemotherapy
resistance and tumor recurrence.
Killing these highly-resistant GBM cancer stem cells is
considered to be a fundamental requirement to successfully treating
this highly destructive disease.
All patient derived cancer cells represented in the library
responded to TRXE-009 at clinically relevant doses, suggesting a
strong therapeutic potential.
The studies were conducted by Drs John
Boockvar and Marc Symons at
the Feinstein Institute for Medical Research (Feinstein) and with
which Novogen is forging a strong collaboration to oversee
advancing TRXE-009 into the clinic for adult and pediatric brain
cancers.
These findings join with other recently announced pre-clinical
studies showing that TRXE-009 is highly cytotoxic of
chemo-resistant pediatric brain cancers such as Diffuse Intrinsic
Pontine Glioma (DIPG) as well as other pediatric neural and neural
crest-derived tumors (i.e. medulloblastoma and neuroblastoma,
respectively). Together, these studies suggest that TRXE-009 is a
unique drug candidate in preferentially targeting tumors with a
common embryonic origin in neural/neural crest cells.
The next step in this drug's development is to confirm it's
ability to cross the blood-brain barrier, a key filtering mechanism
that effectively blocks the majority of chemotherapic drugs from
reaching brain tissue.
TRXE-009 was designed to cross the blood-brain barrier and has
been formulated as a proprietary drug product known as Trilexium.
It is anticipated that Trilexium will have application in the
treatment of cancers both with and without brain involvement.
Trilexium is due to enter a Phase 1 study in early-2016.
In conjunction with Feinstein, alternative means of delivering
TRXE-009 to the brain are under investigation including direct
injection into the brain cancer by the process known as
convection-enhanced delivery, and the use of lipid brain-targeting
particles injected intravenously.
Dr. Graham Kelly, Novogen Group CEO, said, "TRXE-009
has been a drug development success story, thanks to a team led by
Andrew Heaton PhD and Eleanor Ager,
PhD. The TRXE-009 story started with the discovery of a compound
that was highly cytotoxic against GBM brain cells that came from
patients who had failed to respond to Temozolomide, the only
standard of care chemotherapy for GBM; it then showed itself to be
an equally effective killer of GBM cancer stem cells; it also is
highly active in vitro against a range of pediatric brain cancer
cells that are notoriously resistant o chemotherapy; it has been
designed to cross the blood-brain barrier; it shows little toxicity
against normal human brain cells (astrocytes) in vitro; in its
parenteral delivery form, the Trilexium drug-product is highly
active in animal models of xenografted human tumors, including GBM,
and is reasonably well tolerated. So far it has ticked every box
asked of it.
"The urgent need to find a successful treatment for devastating
cancers such as primary and secondary brain cancers in adults and
children is what is driving our collaboration with Feinstein to
bring TRXE-009 into the clinic," Kelly added.
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 the name give to a proprietary parenteral
formulation of TRXE-009 selected for its ability to maximize
systemic drug delivery and effectiveness in pre-clinical rodent
models of human cancer.
Further information is available on our website
www.novogen.com.
About the Feinstein Institute of Medical Research
Feinstein is the research entity of the North Shore-LIJ Health
System, New York, one of the
largest healthcare providers in the US and the largest integrated
health system in the State of New
York.
John Boockvar MD holds the
following appointments:
- Director, Brain Tumor and
Pituitary/Neuroendocrine Center
- Department of Neurosurgery
- The New York Head and Neck Institute
- Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital
- Investigator, Laboratory for Brain Tumor Biology and
Therapy
- Center for Neuroscience and Oncology
- Director, Brain Tumor Biotech Center
- Feinstein Institute for Medical Research
- Professor of Neurosurgery and Otolaryngology/Head and Neck
Surgery
- Department of Neurosurgery
- Hofstra-North Shore LIJ School of Medicine
Marc Symons PhD holds the following appointments:
- Investigator, The Feinstein Institute for Medical Research
- Co-Director, Brain Tumor Biotech Center, The Feinstein
Institute for Medical Research
- Director, Light Microscopy Facility, The Feinstein Institute
for Medical
- Professor, Department of Molecular Medicine and Department of
Neurosurgery, Hofstra North Shore-LIJ School of Medicine
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 [DRUG], 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/us-studies-confirm-ability-of-trxe-009-to-kill-brain-cancer-stem-cells-300045235.html
SOURCE Novogen Limited