Australian Investigational Product Promotes Healing in Venous Stasis Ulcers
July 12 2005 - 1:36PM
PR Newswire (US)
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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