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NRT - ASX Company Announcement
7 February 2000
Part 1/1
HOMEX - Sydney
Anti-Cancer Drug enters Phase 1 Clinical Trials
Australian pharmaceutical company, Novogen Limited, today announced
that its anti-cancer drug, NV-06, has been approved for human
clinical trialing and will enter a Phase 1 trial immediately.
The initial trial is to be conducted at a major public hospital in
Sydney, Australia, which has granted ethical approval for the trial
to proceed. The trial will provide preliminary pharmacokinetic and
tolerability data on the intravenous form of the drug to enable
subsequent cancer treatment trials to be performed.
NV-06 is a synthetic version of a naturally-occurring human phenolic
hormone discovered by Novogen scientists that has demonstrated
significant anti-cancer activity in the laboratory against a wide
range of human cancer cells including breast, prostate, large bowel,
and leukaemia cancers. The company is developing the compound for the
treatment of prostate cancer, the most common cause of cancer related
deaths in men.
Professor Alan Husband, Research Director at Novogen, said the
approval for clinical trialing marked a significant milestone in the
company's drug development program.
"Typically only about 1 in 1,000 new drug compounds that enter
pre-clinical testing ever make it to Phase 1 clinical trials because
of unacceptable toxicity, difficulties in synthesis or lack of
efficacy in laboratory models of disease," Professor Husband said.
"NV-06 has passed all these tests.
"NV-06 is now at the stage where industry standards predict a one in
five chance of successfully reaching new drug registration stage,"
Professor Husband said.
Results of the trial would form part of a submission to the United
States, Food and Drug Administration (FDA), for approval for human
clinical trials to be conducted in cancer patients in the USA.
Professor Husband said the success of NV-06 in treating human
prostate tumours in animals and its acceptance for human testing
confirmed the original vision of Novogen's founder, Dr Graham Kelly.
"Dr Kelly formed the view that phenolic hormones produced in the
human body from plant derived isoflavones are not only essential to
maintenance of human health but have a profound effect on regulating
cellular growth and differentiation," Professor Husband said.
"Their selective effect on cancer cells is manifested via a variety
of pathways including induction of cell differentiation, inhibition
of cell proliferation, and induction of programmed death among cancer
"The observation of a lower incidence of prostate cancer in
populations where legumes form an important part of the diet was the
original trigger for the concept that legumes contain substances
which have important health benefits.
"Our subsequent discovery of the phenolic compounds which the human
body manufactures from the isoflavones found in legumes provided the
key to a whole range of new pharmaceutical opportunities."
Novogen had completed a pilot production facility for the manufacture
of NV-06 to approved pharmaceutical standards and would continue to
manufacture the drug throughout the clinical development program.
Novogen's Managing Director, Mr Christopher Naughton said the market
for a prostate cancer treatment was considerable with more than
300,000 new cases of prostate cancer diagnosed each year in the US,
"There are currently no other therapeutic treatments available for
prostate cancer," Mr Naughton said.
"Current treatments rely on drugs which simply block the action of
male hormones, on radical surgical interventions or on radiotherapy.
"If successful in the ensuing clinical trials, we would expect NV-06
to take a significant share of the available market."
The Australian Government's R&D Start program had provided funding of
up to $2.79M to assist in the development of NV-06.
Novogen expects to make submissions to the FDA for US clinical trials
approval during the course of 2000.
Novogen is listed on the ASX (code NRT) and in the US on the NASDAQ
(code NVGN)
Issued for : Novogen Limited
For further
information : Mr Christopher Naughton, Managing Director,
Novogen Limited
Professor Alan Husband, Research Director,
Novogen Limited,
Tel(02)9878 0088
Issued by : Westbrook Communications
Contact: David Reid Tel (02) 9231 0922
Home (02) 9569 9575
ends - AAP
07-02 1133

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