SOURCE: Novogen, Limited

December 04, 2007 08:01 ET

Novogen's Investigational Drug for Inflammatory Bowel Disease Has Positive Results Following Phase Ib Trial

STAMFORD, CT and SYDNEY, AUSTRALIA--(Marketwire - December 4, 2007) - A recently completed Phase Ib clinical trial of a new drug to treat inflammatory bowel disease (IBD) indicates that treatment may be possible with just a single daily dose.

The drug, NV-52, is a novel compound being developed by Australian pharmaceutical company Novogen Limited (ASX: NRT) (NASDAQ: NVGN), as an oral agent for the maintenance of remission in IBD.

IBD is a debilitating illness which comprises two syndromes -- ulcerative colitis involving mainly the colon and Crohn's disease which can affect the entire gastrointestinal tract. IBD sufferers experience periods of diarrhoea, bleeding, pain and extreme fatigue, and in intractable cases may require surgical resection of portions of the bowel.

IBD is characterised by periods of remission, during which symptoms are controlled by a variety of drugs. However, relapse where symptoms recur is very common and often needs hospitalisation. There is no cure for IBD, and currently available medications are unable to prevent disease 'flares.' As well, all therapies have side effects which compromise quality of life significantly.

The NV-52 Phase Ib study was conducted under the direction of clinical pharmacologist, Professor Laurie Howes, Professor of Pharmacology and Therapeutics at Griffith and Bond Universities.

In this latest study, NV-52 was administered just once daily over a seven day period to nine healthy volunteers. During that time, the levels of NV-52 were measured in the blood, and a wide range of safety assessments undertaken.

Following this once daily dosing regime, concentrations of NV-52 were maintained in the plasma of the volunteers at the level associated with suppression of colitis in the mouse model of IBD. This suggests that if the drug can be demonstrated to be effective in humans, only once daily dosing of NV-52 would be required to enable control of symptoms in IBD patients. Importantly, there were no adverse events and no side effects reported during the study.

"These results indicated that oral therapy with just one dose of NV-52 each day would provide plasma levels in IBD patients that were similar to those which were effective in mice," Professor Howes said. "Furthermore, chronic dosing with NV-52 caused no abnormalities in any of the volunteers, confirming NV-52's excellent safety profile. Further studies are now appropriate to determine whether NV-52 is effective in maintaining remission in IBD patients."

Program Leader of the Novogen Anti-inflammatory and Cardiovascular Drug Research Program, Dr. Cath Walker, said, "These data suggest that NV-52 appears to be a safe and non-toxic therapy which, if proven to be effective in humans, will enable the prolonged maintenance of remission in IBD in the absence of drug side effects."

NV-52 is a synthetic phenolic derivative. NV-52 given orally is protective in a mouse model of colitis, where it has been effective at not only reducing the severity of acute inflammation in the bowel, but at inhibiting its initiation. Formal toxicology testing has demonstrated that NV-52 is a completely non-toxic compound, causing no adverse effects in animals, as well as no genotoxic or mutagenic effects.

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.

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.

Contact Information

  • For Further Information:
    Christopher Naughton
    Managing Director
    Novogen Limited
    TEL (02) 9878 0088
    http://www.novogen.com

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