Novogen Limited (SYDNEY, Australia) announced that its investigational anti-inflammatory compound NV-52, an isoflavonoid-based drug candidate, is entering its second human clinical study following the successful completion of toxicology testing. The clinical trial will be conducted at the Pacific Private Hospital in Brisbane, Queensland, under the direction of clinical pharmacologist Laurie Howes, MB, BS, PhD, FRACP, professor of pharmacology and therapeutics at Griffith University and professor of medicine at Bond University. In this study 12 healthy 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. The company believes that completion of this current study 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.

This study was cleared to begin following the successful completion of a phase Ia study that confirmed the bioavailability of the drug in oral form, and its safety when administered at an acute dose. Toxicology testing in animals has indicated that NV-52 is a completely nontoxic compound, causing no adverse effects. NV-52 has also been demonstrated to have no genotoxic or mutagenic effects. In a mouse model of inflammatory bowel disease, administration of NV-52 resulted in reduction in the occurrence and severity of clinical signs, reduced body weight loss, reduced recovery time, and reduction in colonic ulceration.

—A. Techman

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