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Novogen Cardiovascular Drug Enters Phase I Clinical Trial
| Source: Novogen, Limited
SYDNEY, AUSTRALIA and NEW CANAAN, CT--(Marketwire - April 2, 2008) - 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.
Though 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.
About Novogen Limited:
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.
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