Norwood Abbey planning clinical trial

Norwood Abbey is in the midst of planning an international clinical trial examining the use of its Gonadotropin Releasing Hormone (GnRH) analogue drugs to revive the immune system in patients with HIV/AIDS.

The phase II trial, which will be based at the University Hospital in Basel, Switzerland, will use GnRH analogues in combination with standard HIV treatment regimes, which reduce the viral load. GnRH analogues work by temporarily suppressing sex hormone production, allowing thymus regeneration and production of new T cells, to replace those lost due to the viral infection.

The aims of the trial will include restoration of the immune system in patients with HIV/AIDS, preparation of the immune system to better respond to vaccines, and potential use in gene therapy.

"It is our belief that if we can turn the immune systems of these patients back on, we will initially be able to stabilise the condition of these patients and eventually eradicate the virus from the patients body. The beauty of this treatment is that it is the patient's own body and Mother Nature that do all the work," said Associate Prof Richard Boyd, the Monash researcher who leads the immunology team at Norwood.

The drugs have already been tested in Australia in prostate cancer patients and patients receiving bone marrow transplants, showing improved thymus function and minimal side effects.

According to Norwood executive chairman Peter Hansen, the trial will be run by an international team of researchers with the endorsement of the US National Institutes of Health's Vaccine Research Centre. The team is currently putting the trial protocol together, he said, with a lot of work going into the methodology and particularly the timing of the GnRH treatment.

In addition, the trial data will belong to Norwood for use in possible submissions to regulatory agencies. The company expects that the trial will get underway at the end of this year, or beginning of 2004, with results available by the end of 2004. And as the drug has already been approved for use in breast and prostate cancer patients, safety studies are not required.

"The best part of the story is the quality of people with whom we are associated," said Hansen. Norwood Immunology recently appointed a board of eminent researchers from around the world, who have been instrumental in bringing the company's R&D activities to the fore.

Monash takes equity position

Norwood Immunology has entered into a full licensing agreement with Monash University covering all aspects of the immunology project. As a result of the agreement, the University has taken an equity position in the company through its commercialisation arm Monash Commercial, initially set at 3.125 per cent.

"Norwood Abbey's core expertise is in the management, marketing and commercialisation of medical technologies. The decision by Monash to take equity underscores the special quality of Norwood Abbey and shows the way forward in marrying research and business. Norwood has invested in excess of $6.0 million in the project and currently believes that, even after planned capital raisings, it will continue to hold a very substantial majority shareholding," said Hansen.

"This equity partnership recognises Monash's belief in Norwood's ability to translate these scientific discoveries into a commercially viable project," said Monash Deputy Vice-Chancellor Prof Gary Bouma.