Sydney, Australia and New Canaan, Connecticut. Novogen today 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. 

About NV-27 

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 processes causing restenosis are complex, but occur as a direct result of vessel injury during the stenting procedure, local inflammation and remodelling, together with the same processes of atherosclerosis that caused the vessel to block initially. NV-27 has been demonstrated to inhibit those processes in vitro via a variety of mechanisms. Importantly, orally administered NV-27 has been extremely effective in protecting against restenosis following endothelial injury in animal studies. NV-27 therefore appears to be ideally suited as an orally delivered agent to reduce restenosis following coronary artery stenting. 

About restenosis 

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’.  

Depending on the type of stent used, the type of lesion and whether or not the patient is a diabetic and/or a smoker, restenosis may occur in up to 50% of procedures. The stent then needs to be replaced with another. If the disease is very severe, a patient may undergo bypass surgery where the coronary arteries are replaced with veins from other parts of the body. Again, restenosis can occur, requiring the surgery to be repeated. 

Whilst the addition of immunosuppressive or anti-proliferative agents such as coating on stents (so called drug-eluting stents) have reduced the occurrence of restenosis, it still remains a significant clinical problem, the results of which can be catastrophic.  

Novogen Limited (ASX: NRT NASDAQ: NVGN) is an Australian biotechnology company that has patented isoflavone technology for the treatment and prevention of degenerative diseases and disorders. Over the past ten years, Novogen has conducted the largest and most comprehensive isoflavone clinical testing programs in the world. Novogen is involved in drug discovery and product development for disorders that are commonly associated with aging and coordinates an international clinical research and development program with external collaborators, hospitals and universities. For more information, visit www.novogen.com.