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International Trials for Norwood's AIDS Research

Business Wire - June 18, 2003


MELBOURNE, Australia-- Norwood Abbey Ltd. announced that Australian research on rejuvenating the immune system, which could significantly help HIV/AIDS patients, has been seized upon by a team of distinguished international scientists for clinical trials.

It is planned that up to 50 patients will undergo treatment in Europe using a novel method aimed at preventing fatal AIDS-related illnesses, which has been developed by the Melbourne-based biotechnology business development company Norwood Abbey together with its partner Monash University. The trial will be centered around the renowned University Hospital in Basel, Switzerland and involve input from the American National Institutes of Health (NIH).

A leading researcher, Professor Manuel Battegay of Basel's University Hospital, today hailed the project as an "outstanding example of international cooperation."

A major problem confronting HIV/AIDS patients is the recovery of the specialized white blood cells, called T cells, which are destroyed by the HIV infection. These immune cells are not only needed to control the virus, but also to prevent other severe, often fatal, infections. The problem is that the thymus, the organ that exclusively produces the T cells, is most unexpectedly "turned off" early in life by the normal elevation of sex steroids from the onset of puberty. HIV/AIDS patients therefore have no means of restoring their immune defenses.

Monash and Norwood Abbey have shown in both clinical and animal studies that temporary chemical blocking of sex steroid production via the use of an existing class of drugs, GnRH analogues, can regenerate the thymus, and thereby replace lost T cells and also prompt existing T cells to function better.

"Rebooting" the immune system creates a source of new T cells, the body's main defense against disease. "It is our belief that if we can turn the immune systems of these patients back on, we will initially be able to stabilize the condition of these patients and eventually eradicate the virus from the patients body. The beauty of this treatment is that it is the patients' own body and Mother Nature that do all the work," commented Associate Professor Richard Boyd of Monash University.

"We currently have good anti-HIV drugs that act on the virus itself but we urgently need agents that specifically boost the immune system. GnRH analogues could potentially be used in this way," said Professor Sharon Lewin, Director of Infectious Diseases at the Alfred Hospital in Melbourne.

"If this therapy can be translated to HIV/AIDS patients, it promises to overcome one of the most important hurdles in HIV therapy," said Dr. Battegay. These thoughts were echoed by fellow Basel immunologist, Professor George Hollander. "We are delighted to be able to move to this globally important trial based on such excellent research developed in Melbourne."

The National Institutes of Health is part of the U.S. Government's Department of Health. Daniel Douek, Chief of the Human Immunology Section of the NIH Vaccine Research Center in Washington, said, "The NIH is gratified to be involved with pre-eminent HIV/AIDS research groups in Europe to help in this vital work. The work in Australia to potentially create a major component of the therapy for HIV treatment is most impressive." The Swiss-centered trial will be run simultaneously on HIV/AIDS patients in Australia.

The aims of the trial include:

-- Restoring a collapsed immune system

-- Programming or preparing the immune system to better respond to vaccines

-- Investigating its potential use in gene therapy

Associate Professor Richard Boyd also stated, "The GnRH analogues have been successfully used for many years in the treatment of prostate and breast cancer. As this is a new use for an existing class of drugs, the time to validate the new indication is relatively short and therefore treatment has the potential to be in the clinic within a couple of years."

Welcoming the trial, the chairman of Norwood Abbey, Mr. Peter Hansen, said today that he recently met the leaders of this new international research team and was impressed by their enthusiastic endorsement. "This is a further example of how a team combining researchers, a university and a biotechnology business development company can move quickly with the likelihood of outstanding results."

The planned HIV/AIDS study follows encouraging results from Melbourne-based studies involving patients with prostate cancer and patients undergoing bone marrow transplantation.

To find out more about the company, visit www.norwoodabbey.com.

Norwood Abbey Ltd. is a drug delivery and immunology company with three proprietary delivery platforms in various stages of commercialization and development. Its delivery technologies include laser-assisted delivery, micro-needle arrays, needle-less injection system and pressure wave technology for the transfer of both drugs and genetic material. In addition, the Company holds patent applications for the use of GnRH analogue drugs in the re-growth of the Thymus gland and production of new T-cells. GnRH drugs are already approved for the treatment of prostate and breast cancer and have been available on the market for many years.

CONTACT: Norwood Abbey Ltd.

Peter Hansen, 011-61-3-9782-7333

Jeff Bell, 011-61-3-9782-7333

or

U.S. Investor Contacts:

Lippert/Heilshorn & Associates, Inc.

Kim Sutton Golodetz, 212-838-3777, kgolodetz@lhai.com

Bruce Voss, 310-691-7100, bvoss@lhai.com

www.lhai.com

SOURCE: Norwood Abbey Ltd.


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