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Marshall Edwards Licenses the Investigational Anti-Cancer Compound NV-128 From Novogen Limited
| Source: Marshall Edwards, Inc.
NEW CANAAN, CT and SYDNEY, AUSTRALIA--(Marketwire - August 5, 2009) - Novogen Limited (ASX : NRT ) (NASDAQ : NVGN ) and Marshall Edwards, Inc. (NASDAQ : MSHL ) have
concluded a license agreement for Marshall Edwards to develop and
commercialize the oncology compound
NV-128.
NV-128 is a cancer compound which has been shown in pre-clinical studies to
promote cancer cell death in multi-drug resistant cancer cells by inducing
caspase-independent DNA degradation and cancer cell death via the AKT-mTOR
pathway.
The terms of the license consist of a single upfront payment to Novogen of
US$1.5million, a series of payments for reaching the milestones of US
Investigational New Drug (IND) approval, entering human testing at phases
II and III and receipt of a New Drug Application for marketing and a
royalty on sales of five per cent. Marshall Edwards will fund the ongoing
clinical programs and is responsible for the commercial development of the
drug.
Marshall Edwards is also the licensee of the Novogen developed
investigational anti-cancer drugs phenoxodiol and triphendiol that are
currently in clinical development. The Company has concluded recruitment
in the phase III Ovature trial for phenoxodiol in chemotherapy resistant
ovarian cancer, and has received approval from the US FDA to trial
triphendiol in clinical studies in the US for pancreatic cancer and
cholangiocarcinoma. Triphendiol also has orphan drug status from the FDA
for these indications and late stage melanoma.
The Chairman of Marshall Edwards, Professor Bryan Williams, said the
in-licensing of the mTOR inhibitor NV-128 is an exciting extension to the
MSHL portfolio. Each of the drugs in the company portfolio has the benefit
of preclinical activity against hard to treat cancers and an expected
safety profile that makes their potential as effective anti-cancer agents
highly promising.
"NV-128 has a different mode of action to our current drug candidates and
its advantages over other mTOR inhibitors auger well for an exciting and
valuable addition to the pharmaceutical armamentarium of new cancer
treatments."
About NV-128
NV-128 does not rely on the traditional approach of caspase-mediated
apoptosis, a death mechanism which is not effective in cancer cells that
have become resistant to chemotherapy. Rather, NV-128 uncouples a signal
transduction cascade which has a key role in driving protein translation
and uncontrolled cancer cell proliferation. Further, NV-128 induces
mitochondrial depolarization via the novel mTOR pathway. In cancer cells,
mTOR signals enhance tumor growth and may be associated with resistance to
conventional therapies. Inhibition of the mTOR pathway appears to shut
down many of these survival pathways, including proteins that protect the
mitochondria of cancer cells. Animal studies have shown that NV-128 not
only significantly retards tumor proliferation, inhibiting the progression
of ovarian cancers-engrafted into mice, but produces this effect without
apparent toxicity. This effect was shown to be due to caspase-independent
pathways involving inhibition of the mTOR pathway. Unlike analogues of
rapamycin, which target only mTORC1, NV-128's capacity to inhibit mTOR
phosphorylation enables it to inhibit both mTORC1 and mTORC2 activity.
This blocks growth factor-driven activation of AKT and the potential for
development of chemoresistance.
Marshall Edwards, Inc. is a US clinical development oncology company and is
majority owned by Novogen Limited.
Novogen Limited, based in Sydney, Australia, is an Australian biotechnology
company that is specializing in the development of therapeutics based on
regulation of the sphingomyelin pathway.
More information on phenoxodiol and on the Novogen group of companies can
be found at www.marshalledwardsinc.com and www.novogen.com.
Under U.S. law, a new drug cannot be marketed until it has been
investigated in clinical trials and approved by the FDA as being safe and
effective for the intended use. Statements included in this press release
that are not historical in nature are "forward-looking statements" within
the meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. You should be aware that our actual results
could differ materially from those contained in the forward-looking
statements, which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not limited
to, our failure to successfully commercialize our product candidates; costs
and delays in the development and/or FDA approval, or the failure to obtain
such approval, of our product candidates; uncertainties in clinical trial
results; our inability to maintain or enter into, and the risks resulting
from our dependence upon, collaboration or contractual arrangements
necessary for the development, manufacture, commercialization, marketing,
sales and distribution of any products; competitive factors; our inability
to protect our patents or proprietary rights and obtain necessary rights to
third party patents and intellectual property to operate our business; our
inability to operate our business without infringing the patents and
proprietary rights of others; general economic conditions; the failure of
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additional required financing; technological changes; government
regulation; changes in industry practice; and one-time events. We do not
intend to update any of these factors or to publicly announce the results
of any revisions to these forward-looking statements.