KZIA Kazia Therapeutics Ltd

Australian Investigational Product Promotes Healing in Venous Stasis Ulcers STAMFORD, Conn., July 12 /PRNewswire/ -- Novogen today announced the results of a Phase II clinical trial of its investigational wound healing compound, Glucoprime, in venous stasis ulcers. The trial was conducted in Australia by Novogen subsidiary, Glycotex Inc., which holds the rights to the Novogen glucan technology. The trial involved 60 patients with chronic deep venous stasis ulcers of the legs. In the double-blind trial, patients were randomized either to a placebo arm, or to low-dose (0.1%) Glucoprime arm or high-dose (1%) Glucoprime arm. The Glucoprime was formulated as a gel and applied to the wound surface three times weekly. Treatment was over 12 weeks and the ulcers were monitored for size every two weeks. Glucoprime was assessed for its effect on both the rate of wound closure and the degree of healing. Glucoprime promoted the rate at which wounds healed, with Glucoprime- treated ulcers healing at a significantly faster rate (2 millimeters per day) compared to placebo-treated ulcers. The overall mean level of healing over the 12 weeks was 10 percent for the placebo group, 59 percent for the low-dose, Glucoprime arm, and 55 percent for the high-dose, Glucoprime arm. The outcome was confounded by the large discrepancy in the size of the ulcers, with the two Glucoprime treatment groups having substantially larger average ulcer sizes than the placebo group, despite patients being randomized. This discrepancy will be addressed in future studies based on guidance issued by the U.S. Food and Drug Administration (FDA) on development of products for treatment of chronic wounds, which suggest stratification based on ulcer size prior to randomization. The trial was conducted at two sites in Australia -- Royal North Shore Hospital, Northern Metropolitan Area Health Service in Sydney, and Heidelberg Repatriation Hospital in Melbourne. The Principal Investigators were Dr. Rod Lane and Professor Michael Woodward. Dr. Rod Lane said the results were very encouraging, given the chronic nature of the wounds and the fact that every other product his team had looked at over the years had failed to promote healing to a meaningful level. "This is a substantial community health problem, and one that is likely to get larger as our life expectancy increases," Dr. Lane said. "Glucoprime is a highly promising compound," Dr. Lane added. Professor Michael Woodward said there was a need for better products to promote wound healing. "The pain, suffering and cost for medical treatment of leg ulcers is immense, and these results are very encouraging," Professor Woodward said. Executive Director of Glycotex, Inc., Professor Graham Kelly, said the result confirmed confidence in the ability of Glucoprime to promote wound healing. "The fact that it has had such a positive effect in such difficult wounds where standard care has failed suggests that the technology has utility across a wide range of tissue repair applications," Professor Kelly said. "Our intention in the first instance is to conduct a regulatory study with a view to getting this product approved for marketing for treatment of venous stasis ulcers." Glycotex is also planning on pursuing other applications of this product and the technology in general across a range of wound healing applications. About venous stasis ulcers Venous stasis ulcers accompany conditions such as varicose veins where blood flow from the legs back to the heart is impeded. Pooling of blood in the lower limbs leads to skin breakdown and eventual ulceration that generally requires intensive therapy to reverse. Effective healing of these ulcers is very difficult and few treatments have been developed and approved. The development of a cost-effective and practical treatment in the trophic (skin) ulcer area remains an imperative for medicine. Approximately 1 to 2 percent of the adult population of the Western world suffers from ulceration due to venous insufficiency at some stage, a situation which costs the public health system upwards of US$3 billion a year in the UK and the US alone (Journal of Vascular Surgery, Nov 2000). About Glucoprime Glucoprime is a patented form of (1->3) (1->6)-beta-D-glucan, a carbohydrate extracted from yeast cell walls and which activates the cells within a wound that control the wound healing process. Glucoprime is an investigational product and, as such, is not marketed in the United States or other countries. About Glycotex, Inc. Glycotex is a U.S.-based company specializing in the development of products intended to promote tissue repair. Glycotex is a subsidiary of Novogen (84.3 percent shareholding) and is licensed by Novogen to develop the glucan technology platform. About Novogen Novogen is a bio-pharmaceutical company focused on the development of therapeutics derived from its phenolic and glucan technology platforms. Novogen is listed both on the Australian Stock Market (ASX:NRT) and NASDAQ (NASDAQ:NVGN). More information can be found at http://www.novogen.com/. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. 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 CONTACT: David Sheon, +1-202-518-6321, for Novogen Web site: http://www.novogen.com/

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