Novogen says new study shows oral therapy with NV-52 feasible

By Ted A. Knutson

Washington, March 2 - Novogen Ltd. said Thursday a recently completed phase 1 clinical trial of NV-52, an anti-inflammatory compound to treat inflammatory bowel disease, has demonstrated rapid absorption indicating potential for development as an oral therapy.

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.

The drug was given orally to six 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 six subjects.

Maximum plasma concentrations occurred about four hours after drug administration and the plasma half life, time at which half of the drug was eliminated, was about eight hours.

There were no adverse events reported during the study.

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, diarrhea, 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.

Novogen is a North Ryde, Australia-based biotechnology company.

The announcement was made in a 6-K filing with the Securities and Exchange Commission.

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