Novogen has announced the commencement of a phase I human clinical trial of the novel cardiovascular drug, NV-27. This drug is designed to reduce restenosis or re-blocking of arteries after surgery to clear blockages, commonly involving insertion of arterial stents. The study is being conducted in association with Bond University, Queensland, Australia under the direction of clinical pharmacologist, Professor Laurie Howes.

"We are very pleased to be involved in the development of this compound which has the potential to assist in the management of restenosis in coronary artery stenting" said Dr Laurie Howes, Professor of Pharmacology and Therapeutics at Griffith and Bond University Medical School in Queensland, Australia, and the Principal Investigator of this study.

"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 Prof Howes.

Program Leader of the Novogen anti-inflammatory and cardiovascular drug research program, Dr Cath Walker, said "Restenosis has been termed the 'Achilles heel' of interventional cardiology. There is an unmet therapeutic need for a simple, safe and durable solution to restenosis. NV-27 is well placed to address this need".

The current study is the first step in the clinical development of the drug. It will involve initial testing in a small number of healthy human volunteers to determine the safety and kinetics of NV-27 in humans. To date it has been demonstrated to be safe in animal studies and no toxic side effects are expected.

The drug, code named NV-27, has been developed from the Novogen flavanoid technology platform. It is a synthetic analogue based on the phenolic structure of naturally-occurring isoflavones. The drug has been designed to be administered orally as an adjunctive therapy to reduce restenosis following angioplasty (surgical unblocking of arteries) with or without stenting, or coronary artery bypass surgery.

The coronary arteries supply blood to the heart. Through a variety of mechanisms including aging, a diet high in fat, smoking and inadequate exercise, atherosclerosis causes these arteries to block, resulting in angina (heart pain) or more critically an acute myocardial infarction (heart attack).

These vessels can be unblocked by a process called angioplasty, where the vessel is reopened using a balloon inflated inside the artery. More commonly, a small metal scaffold called a stent can be inserted to hold the artery open for an extended period. Unfortunately, the vessel often blocks up again in a process called 'restenosis'.

Novogen Limited is biotechnology company that has patented isoflavone technology for the treatment and prevention of degenerative diseases and disorders.