Novogen Limited's investigational anti-inflammatory compound NV-52 is entering its second human clinical study following the successful completion of toxicology testing.

NV-52 is a novel compound developed by Novogen to target inflammatory bowel disease.

This study was cleared to begin following the successful completion of a phase Ia study that confirmed the bio-availability of the drug, in oral form, and its safety when administered at an acute dose.

The clinical trial will be conducted at the Pacific Private Hospital in Brisbane, Queensland under the direction of clinical pharmacologist, Prof. Laurie Howes, Prof. of Pharmacology and Therapeutics at Griffith University and a Prof. of Medicine at Bond University.

In this study 12 volunteers will be administered, NV-52 in a repeat dose over seven days.

This study seeks to extend the safety data by looking at the use of the drug on a long-term basis, as well as testing the ability of the drug to change certain inflammatory markers in the serum. Researchers hope this will provide a platform to subsequently take the drug into patients with inflammatory bowel disease.

Formal toxicology testing has indicated that NV-52 is a completely non-toxic compound, causing no adverse effects in animals. NV-52 has also been demonstrated to have no genotoxic or mutagenic effects.

Prof. Howes stated the lack of toxicity of the drug would enable it to be used over extended periods of treatment which would make it highly suitable for maintaining remission in inflammatory bowel disease. "If the efficacy in humans is similar to that already observed in mice, this new drug will have the potential to offer new therapeutic opportunities in this difficult disease indication,"

NV-52 is a novel compound designed by Novogen from its isoflavonoid technology platform. While displaying a broad range of anti-inflammatory effects, it is being developed clinically to treat inflammatory bowel disease.

Inflammatory bowel disease, which includes ulcerative colitis and Crohn's disease, affects approximately 1 in 1000 individuals, causing pain, diarrhoea, rectal bleeding, weight loss and fatigue and may progress to bowel perforation. 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 totally 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, treatment regimens which prolong the periods of remission without unwanted side effects. Previous animal studies indicated NV-52 appears to be ideally suited as a maintenance therapy to prevent relapse of disease.

The company expects that completion of this current study in human volunteers will enable the commencement of the Phase II development program in which patients with inflammatory bowel diseases will be treated with the drug to determine its utility in prolonging disease remission.