Novogen bowel disease drug set to enter Phase I trial

Biopharmaceutical company Novogen's (ASX:NRT) anti-inflammatory compound NV-52 is set to enter Phase I trials at the Gold Coast Hospital.

"The patients have been recruited, it's just a matter of when the clinical site schedule it," said Novogen research director Alan Husband. "It will either be this week or next week."

NV-52 is a synthetic analogue based on the phenolic structure of naturally-occurring isoflavones and the drug 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.

NV-52 has been shown to be effective in animal studies in reducing the severity of acute inflammatory events in the bowel as well as inhibiting the initiation of these events.

"It works by inhibiting the inflammatory cascade involving thromboxane, and that's known to be one of the mediators that leads to exacerbation of these inflammatory bowel diseases," said Husband. "It's also been demonstrated to work more effectively in preventing disease relapse than actually treating concurrent disease, and that's the sort of therapeutic window we're looking for with drugs for this condition."

The Phase I study will involve initial testing in six healthy human volunteers to determine its safety and the mechanics of accumulation and elimination in humans. "We have extensive experience in the kinetics and safety profile of this class of compounds and expect that the Phase I goals of safety and tolerability will be met in this study," said the principal investigator of the study, Prof Laurie Howes from Griffith University.

"Once we have confidence that the drug is as safe and as well tolerated in humans as well as it obviously is in animals then we would progress to escalating doses and start to use people with the target conditions," said Husband.