Human Clinical Trials to Commence On Novogen's Skin Repair Compound NV-07a.

Business Editors/Health & Medical Writers

BIOWIRE2K

STAMFORD, Conn.--(BW HealthWire)--Sept. 27, 2001

The Queensland Institute for Medical Research (QIMR, Brisbane, Australia) is to commence human clinical trials of a novel synthetic dermatological compound, NV-07a, developed by pharmaceutical company Novogen Limited (NASDAQ:NVGN).

NV-07a has been developed for the repair of sun-damaged skin. The clinical trials have been designed to determine its role in correcting acute sun damage as well as preventing induction of skin cancer. The QIMR Human Ethics Committee has approved the trials, based on NV-07a pre-clinical safety and efficacy data.

In pre-clinical trials conducted by Novogen, NV-07a demonstrated an ability to undo the underlying damage to skin from exposure to ultraviolet light, even when applied to the skin after the damage was inflicted. Sun damage to skin can cause premature aging, but also causes a reduction in the immune response in the skin, which increases the susceptibility to development of various types of skin cancers.

Both of these effects were reversed by topical use of NV-07a as was reflected in reduced incidence of skin cancer in long term pre-clinical studies. NV-07a has commercial potential for use as an after-sun skin repair agent in cosmetics and skin care products.

Novogen's Research Director, Professor Alan Husband, said while public awareness needed to be maintained about the benefits of avoiding excessive sun exposure and the use of sun block creams to prevent sun damage, the World Health Organization's International Agency for Research on Cancer had issued a medical alert warning that the use of sun block creams was not as effective as previously thought.

"The use of these creams reduces sunburn but does not correlate with a reduction in risk of skin cancers such as basal cell carcinoma and cutaneous melanoma," Professor Husband said.

Despite the lack of efficacy for sun block creams already on the market, the current annual spend in the United States on UV sun block creams was $90 million and in Europe the figure was $100 million. The current total skin care market for the world is around $30 billion annually, of which about $6 billion is spent in the U.S.

Novogen's Managing Director, Mr. Christopher Naughton, said Novogen would be managing the clinical development program for NV-07a and then reviewing potential marketing partners for the commercialization of the product.

NV-07a is a phenolic compound from the same class of compounds as Novogen's anti-cancer drug phenoxodiol (now in human clinical phase I/II trials in Australia and the U.S.) and the cardiovascular compound NV-04 (now in pre-clinical trials).

Novogen currently markets internationally the non-prescription menopause product Promensil(TM), the post-menopausal product Rimostil(TM), and the men's health product Trinovin(TM).

The Company 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.

Statements herein that are not descriptions of historical facts are forward-looking and subject to risk and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in the Company's Securities and Exchange Commission filings under "Risk Factors", including risks relating to the early stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).