A recently
completed Phase 1 clinical trial of an investigational drug to treat
inflammatory bowel disease has demonstrated rapid absorption indicating
potential for development as an oral therapy.
The drug, NV-52, is an anti-inflammatory compound developed by Australian
pharmaceutical company, Novogen Limited (Nasdaq: NVGN) (Australia: NRT).
The Phase I study was conducted at the Gold Coast Hospital under the
direction of clinical pharmacologist, Professor Laurie Howes, Professor of
Pharmacology and Therapeutics at Griffith University and a Professor of
Medicine at Bond University.
NV-52 is a synthetic analogue based on the phenolic structure of
naturally-occurring isoflavones, well known for their range of health benefits
when consumed in certain foods and is undergoing development as an orally-
delivered non-toxic agent for the maintenance of remission in inflammatory
bowel disease.
NV-52 was given orally to 6 healthy young male volunteers as a single
dose. Plasma and urine samples were taken immediately prior to drug
administration and up to 48 hours following drug administration.
After the initial appearance of the drug in plasma, levels rose rapidly in
all subjects indicating rapid absorption. The drug appeared to have
reasonably consistent bioavailability in all 6 subjects.
Maximum plasma concentrations occurred approximately 4 hours after drug
administration and the plasma half life (time at which half of the drug was
eliminated) was approximately 8 hours.
Importantly, there were no adverse events reported during the study.
Professor Howes said the results indicated that NV-52 given as an oral
dose was rapidly absorbed and produced appreciable plasma levels in all
volunteers.
"These results indicate that oral therapy with the drug is feasible,"
Professor Howes said.
The completion of this study in human volunteers is the first step in the
clinical development of the drug, demonstrating its safety and the mechanics
of accumulation and elimination in humans.
Inflammatory bowel disease, which includes ulcerative colitis and Crohn's
disease, affects around 1 in 1,000 individuals causing pain, diarrhoea, rectal
bleeding, weight loss and fatigue and may progress to bowel perforation.
Moreover it is believed that such conditions may predispose affected
individuals to colon cancer.
The cause of these diseases is poorly understood and no current management
strategy is effective.
Current treatments do not provide a cure, and all produce significant
unwanted side effects.
The disease usually recurs, with relapse rates of up to 80 per cent within
the first year post-remission.
On this basis, the most effective management strategy is to devise
improved maintenance therapy and treatment regimens which prolong the periods
of remission without unwanted side effects.
Previous animal studies indicated NV-52 appears to be suited as a
maintenance therapy to prevent relapse of disease.
Novogen is an Australian biopharmaceutical company specialising in the
development of therapeutics based on the isoflavonoid chemical structure. The
Company is developing a range of therapeutics across the fields of oncology,
cardiovascular disease and inflammatory diseases and phenoxodiol, its lead
anti-cancer agent is currently in advanced Phase II clinical trialing with its
US listed subsidiary Marshall Edwards Inc. (Nasdaq: MSHL).
More information on the Novogen Group can be found at
novogen and www.marshalledwardsinc.
Under U.S. law, an investigational 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
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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
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development and/or FDA approval, or the failure to obtain such approval, of
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Novogen Limited
www.novogen
www.marshalledwardsinc