KZIA Kazia Therapeutics Ltd

Novogen Cardiovascular Drug Enters Second Human Clinical Trial SYDNEY, Australia, July 6 /PRNewswire-FirstCall/ -- Pharmaceutical company Novogen Limited (NASDAQ:NVGN)(ASX:NRT) is commencing a second human clinical trial to evaluate its investigational cardiovascular drug. The new study will be conducted at the Baker Heart Research Institute in Melbourne using the compound trans-NV-04. Trans-NV-04 is an advanced version of Novogen's experimental NV-04 compound. In the current study, trans-NV-04 will be tested in human subjects who are at risk of cardiovascular disease, but are otherwise healthy. Initially the trial will evaluate safety and tolerability in a dose ranging study. This will be followed by a randomized, cross-over, placebo controlled and double- blind study in subjects receiving either trans-NV-04 or placebo. Effects on a number of cardiovascular risk factors, including arterial stiffness, blood pressure, plasma lipids, circulating adhesion and inflammatory molecules, insulin sensitivity and plasma cortisol will be compared between groups. A trans-NV-04 analogue has been tested in human volunteers in a pre-phase I study reported previously. In that study the effects of direct infusion of the drug into the brachial artery induced elasticity in blood vessels (dilation) and increased forearm blood flow. In the initial human trial, six out of six subjects responded favorably following direct infusion of the compound into the blood stream leading to significant increases in blood flow in a particular artery. Follow-up laboratory studies have identified trans-NV-04 as potentially even more effective than the parent compound but retaining its low side effect and high safety profile. Previous laboratory studies conducted by the Baker team have demonstrated that trans-NV-04, in addition to promoting blood vessel relaxation, acts as an antioxidant and inhibits smooth muscle cell growth in blood vessels, factors contributing to build up of obstructive vascular plaques or atherosclerosis. The current human study will enable a dosing regime to be established which has the potential to be used in healthy subjects to reduce cardiovascular risk factors and in people suffering from atherosclerosis, to reduce the damage in diseased arteries and to hasten the recovery from surgical interventions used to manage such disease, such as by-pass surgery and angioplasty. Novogen's Research Director, Professor Alan Husband, said the trial represented a significant milestone in the Novogen cardio-vascular drug program. "We have already demonstrated that our compounds produce clinically relevant effects in improving cardiovascular function," Professor Husband said. "This human clinical trial is intended to demonstrate that improved cardiovascular function can be realized in patients who are at risk of cardiovascular incidents and subsequently in patients suffering from life- threatening cardiovascular disease." Professor Husband said most currently available drugs used to treat these disorders produced undesirable side effects. "In contrast trans-NV-04 is expected to be sufficiently safe to be administered over long periods without side effects," Professor Husband said. Atherosclerosis, hypercholesterolaemia and associated vascular disease are prevalent in the Western world. It is estimated that more than 300 million individuals in the seven major pharmaceutical markets suffer from hypercholesterolaemia. An estimated US$17.7 billion is spent annually on cardiovascular drugs in the United States alone. The NV-04 research effort has been assisted by an award of A$3.7 million through the Australian government's R&D START program. Trans-NV-04 is an investigational drug not yet approved for marketing in the United States. Novogen is advancing clinical development of its compounds to a point where it can maximize shareholder value through out-licensing. Novogen has developed a patented suite of intellectual property around its technology platform and is coordinating its international research and clinical development programs in collaboration with some of the world's leading medical research centers. More information on the Novogen group of companies and their associated technology developments can be found at http://www.novogen.com/ and at http://www.marshalledwardsinc.com/. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. DATASOURCE: Novogen Limited CONTACT: Professor Alan Husband, Research Director of Novogen Limited, +011 61 (02) 9878 0088; or David Sheon, +1-202-518-6321, for Novogen Limited Web site: http://www.novogen.com/ http://www.marshalledwardsinc.com/

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