+++++++++++++++++++++++++ Australian pharmaceutical company, Novogen Limited, has commenced the human clinical trialling phase of its NV-04 cardiovascular drug program. The Phase I clinical trial in human volunteers is being conducted at the Baker Medical Research institute in Melbourne.
The objective is to evaluate the safety and tolerability of the Novogen drug and to determine its effect on widening of blood vessels (dilatation) which is a mechanism of enhancing blood flow and reducing blood pressure.
The purpose of the trial in healthy subjects is to confirm favourable results obtained in animals in which improved dilatation of blood vessels has been demonstrated with the drug.
Reduced dilatation of arteries is part of the disease process in patients with heart disease, high blood pressure, high blood cholesterol and diabetes.
In separate animal research projects undertaken by the Melbourne research team at the Baker Medical Research Institute it has been shown previously that NV-04 and closely related compounds from the Novogen library promote blood vessel relaxation, lower blood pressure, act as antioxidants and inhibit smooth muscle cell growth in blood vessels, factors contributing to build up of obstructive vascular plaques or atherosclerosis.
Novogen's Research Director, Professor Alan Husband, said "Not only have laboratory studies demonstrated that the synthetic derivative NV-04 was effective, but its derivation from naturally occurring compounds meant it was expected to be sufficiently safe to be administered over long periods without side effects.
"The commercial potential for the NV-04 program is significant with an estimated US$17.7 billion spent annually on cardiovascular drugs in the United States alone," Prof Husband said,
-in view of the anticipated low side effect profile of this class of compounds, we expect to have a share of this growing market."
The NV-04 program has been assisted by an award of $3.75m through the Australian Government's R&D START Program.
For further Information: Professor Alan Husband, Research Director, Novogen Ltd Mr Christopher Naughton, Managing Director, Novogen Ltd. Tel (02) 9878 0088 http://novogen.com
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