NEW CANAAN, CT and SYDNEY, AUSTRALIA -- (Marketwire) -- 08/05/09 -- 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.