Positive phase I data for Novogen's bowel disease drug

By Ruth Beran
Thursday, 02 March, 2006

A recently completed phase I clinical trial of biopharmaceutical company Novogen's (ASX:NRT) anti-inflammatory compound NV-52 has shown rapid absorption indicating its potential as an oral therapy, according to the company.

NV-52 has been designed as an orally-delivered non-toxic agent for the maintenance of remission in inflammatory bowel disease, such as ulcerative colitis and Crohn's disease. It is a synthetic analogue based on the structure of naturally-occurring isoflavones -- oestrogen-like compounds found in certain foods such as soybeans.

Prof Laurie Howes, a clinical pharmacologist from Griffith and Bond Universities, led the phase I study, which was conducted at the Gold Coast Hospital. NV-52 was given orally to six healthy young male volunteers as a single dose with plasma and urine samples taken just before the drug was administered and up to 48 hours afterwards.

Results showed that after the initial appearance of the drug in plasma, levels in all subjects rose rapidly, indicating rapid absorption. Maximum concentration of the drug in the patients' plasma was four hours after the drug was taken, and in 8 hours half of the drug was eliminated from the plasma.

"These results indicate that oral therapy with the drug is feasible," said Howes in a statement.

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