Novogen's Investigational Drug for Inflammatory Bowel Disease Has Positive Results Following Phase Ib Trial
December 04 2007 - 8:01AM
Marketwired
STAMFORD, CT and SYDNEY, AUSTRALIA indicates that treatment may
be possible with just a single daily dose.
The drug, NV-52, is a novel compound being developed by
Australian pharmaceutical company Novogen Limited (ASX: NRT)
(NASDAQ: NVGN), as an oral agent for the maintenance of remission
in IBD.
IBD is a debilitating illness which comprises two syndromes --
ulcerative colitis involving mainly the colon and Crohn's disease
which can affect the entire gastrointestinal tract. IBD sufferers
experience periods of diarrhoea, bleeding, pain and extreme
fatigue, and in intractable cases may require surgical resection of
portions of the bowel.
IBD is characterised by periods of remission, during which
symptoms are controlled by a variety of drugs. However, relapse
where symptoms recur is very common and often needs
hospitalisation. There is no cure for IBD, and currently available
medications are unable to prevent disease 'flares.' As well, all
therapies have side effects which compromise quality of life
significantly.
The NV-52 Phase Ib study was conducted under the direction of
clinical pharmacologist, Professor Laurie Howes, Professor of
Pharmacology and Therapeutics at Griffith and Bond
Universities.
In this latest study, NV-52 was administered just once daily
over a seven day period to nine healthy volunteers. During that
time, the levels of NV-52 were measured in the blood, and a wide
range of safety assessments undertaken.
Following this once daily dosing regime, concentrations of NV-52
were maintained in the plasma of the volunteers at the level
associated with suppression of colitis in the mouse model of IBD.
This suggests that if the drug can be demonstrated to be effective
in humans, only once daily dosing of NV-52 would be required to
enable control of symptoms in IBD patients. Importantly, there were
no adverse events and no side effects reported during the
study.
"These results indicated that oral therapy with just one dose of
NV-52 each day would provide plasma levels in IBD patients that
were similar to those which were effective in mice," Professor
Howes said. "Furthermore, chronic dosing with NV-52 caused no
abnormalities in any of the volunteers, confirming NV-52's
excellent safety profile. Further studies are now appropriate to
determine whether NV-52 is effective in maintaining remission in
IBD patients."
Program Leader of the Novogen Anti-inflammatory and
Cardiovascular Drug Research Program, Dr. Cath Walker, said, "These
data suggest that NV-52 appears to be a safe and non-toxic therapy
which, if proven to be effective in humans, will enable the
prolonged maintenance of remission in IBD in the absence of drug
side effects."
NV-52 is a synthetic phenolic derivative. NV-52 given orally is
protective in a mouse model of colitis, where it has been effective
at not only reducing the severity of acute inflammation in the
bowel, but at inhibiting its initiation. Formal toxicology testing
has demonstrated that NV-52 is a completely non-toxic compound,
causing no adverse effects in animals, as well as no genotoxic or
mutagenic effects.
About Novogen Limited:
Novogen Limited (ASX: NRT) (NASDAQ: NVGN) is an Australian
biotechnology company that has patented isoflavone technology for
the treatment and prevention of degenerative diseases and
disorders. Over the past ten years, Novogen has conducted the
largest and most comprehensive isoflavone clinical testing programs
in the world. Novogen is involved in drug discovery and product
development for disorders that are commonly associated with aging
and coordinates an international clinical research and development
program with external collaborators, hospitals and universities.
For more information, visit 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
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"forward-looking statements" within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
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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
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For Further Information: Christopher Naughton Managing Director
Novogen Limited TEL (02) 9878 0088 http://www.novogen.com Contact:
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