Investigational Drug Targeting Inflammatory Bowel Disease Enters Second Human Clinical Trial
August 09 2006 - 11:42AM
PR Newswire (US)
SYDNEY, Australia and WASHINGTON, Aug. 7 /PRNewswire/ -- Novogen
Limited's (NASDAQ:NVGN) investigational anti-inflammatory compound
NV-52, is entering its second human clinical study following the
successful completion of toxicology testing. NV-52 is a novel
compound developed by Novogen to target inflammatory bowel disease.
This study was cleared to begin following the successful completion
of a Phase Ia study that confirmed the bio-availability of the drug
in oral form, and its safety when administered at an acute dose.
The clinical trial will be conducted at the Pacific Private
Hospital in Brisbane, Queensland under the direction of clinical
pharmacologist, Professor Laurie Howes, Professor of Pharmacology
and Therapeutics at Griffith University and a Professor of Medicine
at Bond University. In this study, 12 volunteers will be
administered NV-52 in a repeat dose over seven days. This study
seeks to extend the safety data by looking at the use of the drug
on a long-term basis, as well as testing the ability of the drug to
change certain inflammatory markers in the serum. Researchers hope
this will provide a platform to subsequently take the drug into
patients with inflammatory bowel disease. Formal toxicology testing
has indicated that NV-52 is a completely non- toxic compound,
causing no adverse effects in animals. NV-52 has also been
demonstrated to have no genotoxic or mutagenic effects. Professor
Howes said the lack of toxicity of the drug would enable it to be
used over extended periods of treatment which would make it highly
suitable for maintaining remission in inflammatory bowel disease.
"If the efficacy in humans is similar to that already observed in
mice, this new drug will have the potential to offer new
therapeutic opportunities in this difficult disease indication,"
Professor Howes said. NV-52 is a novel compound designed by Novogen
from its isoflavonoid technology platform. While displaying a broad
range of anti-inflammatory effects, it is being developed
clinically to treat inflammatory bowel disease. Inflammatory bowel
disease, which includes ulcerative colitis and Crohn's disease,
affects approximately 1 in 1000 individuals, causing pain,
diarrhea, rectal bleeding, weight loss and fatigue and may progress
to bowel perforation. It is believed that such conditions may
predispose affected individuals to colon cancer. The cause of these
diseases is poorly understood and no current management strategy is
totally effective. Current treatments do not provide a cure, and
all produce significant unwanted side effects. The disease usually
recurs, with relapse rates of up to 80 percent within the first
year post-remission. On this basis, the most effective management
strategy is to devise improved maintenance therapy, treatment
regimens which prolong the periods of remission without unwanted
side effects. Previous animal studies indicated NV-52 appears to be
ideally suited as a maintenance therapy to prevent relapse of
disease. The Company expects that completion of this current study
in human volunteers will enable the commencement of the Phase II
development program in which patients with inflammatory bowel
diseases will be treated with the drug to determine its utility in
prolonging disease remission. About Novogen Novogen is an
Australian based biotechnology company in the business of research
and development of drugs derived from its phenolic technology
platform. The Company manages its research and development programs
utilizing the expertise and clinical research capabilities of
universities and hospitals in Australia, USA and Europe. Novogen's
drug program is researching and developing compounds for the
treatment of cancer, cardiovascular disease and anti infmamatory
disease. To date Novogen has had 51 patents granted and a further
240 patents are pending. Novogen's consumer business has conducted
the largest and most comprehensive isoflavone clinical testing
program in the world. Novogen's consumer brands Promensil, and
Trinovin are clinically supported, natural products for women and
men's health. Patents supporting Novogen's consumer brands have
been granted in USA, Europe, Canada and Australia. Further
information on the Novogen Group can be found at
http://www.novogen.com/. This news release does not constitute an
offer to sell or the solicitation of an offer to buy any
securities. The common stock and warrants sold in the offering have
not been registered under the Securities Act of 1933, as amended
(the "Securities Act"), or any state securities laws and may not be
offered or sold in the United States absent registration or an
applicable exemption from registration requirements under the
Securities Act or applicable state securities laws. 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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