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PROGEN'S FIRST U.S. CLINICAL TRIAL WITH PI-88 BEGINS.

The first two patients have been enrolled in Progen Industries Limited (Nasdaq:PGLAF) (ASX:PGL), Brisbane, Australia, Phase I/II trial of anti-cancer drug PI-88.

The trial, which has received ethics committee approval is being conducted in two phases at the University of Colorado Health Sciences Center (CUHSC) in the United States.

The first phase (Phase I) will determine the appropriate dose and safety of the drug when administered subcutaneously (injected under the skin) to patients with advanced malignancies.

The second phase (Phase II) will evaluate the drug's effect on tumour progression in patients with advanced melanoma, and gather information about PI-88's ability to inhibit the formation of blood vessels (angiogenesis) feeding the tumours. This phase will involve patients who have received therapies that have failed or do not have any other treatment options available.

Progen's vice president of Research and Development, Dr. Robert Don said the trial is a significant milestone in Progen's ongoing research and development program with PI-88.

"This trial represents an exciting opportunity for us to learn more about the drug's ability to control cancer," Don said.

"Existing research shows that PI-88 has multiple modes of action that enable it to target both the growth and spread of cancers, giving it a unique advantage over many other cancer treatments."

Don said PI-88 inhibited the action of heparanase, an enzyme involved in the spread of tumours to secondary sites (metastasis), and also inhibited the growth of new blood vessels (angiogenesis) that supply tumours and allow them to grow and spread.

Don said Progen had chosen melanoma as the disease target for the first Phase II study with PI-88 because it allowed for samples of skin lesions (biopsies) to be taken and also enabled direct observation of changes in blood vessels.

The principal investigator conducting the trial is Dr. S. Gail Eckhardt, an associate professor at the CUHSC and a clinician with a long-standing interest in angiogenesis inhibitors as therapies for cancer.

"Tumour angiogenesis continues to be a very important target for anti-cancer therapy. PI-88 is a compound that is unique among other angiogenesis inhibitors, and we are looking forward to investigating its potential in treating cancer patients," Dr. Eckhardt said.

The PI-88 trial at the CUHSC follows the completion of a Phase Ib trial of the drug in cancer patients in February this year at the Centre for Developmental Cancer Therapeutics involving the Peter McCallum Cancer Institute and the Royal Melbourne Hospital.

A Phase I trial examining subcutaneous administration of PI-88 in healthy volunteers is nearing completion at the specialist clinical research organization, Medeval, in the United Kingdom.

Progen's strategic alliance partner, Medigen Biotechnology Corporation, is currently conducting an independent Phase Ib trial of PI-88 in Taiwanese patients suffering advanced forms of cancer.

Progen plans to form a strategic alliance with a reputable pharmaceutical or biotechnology company at the completion of Phase II trials to take PI-88's development through Phase III trials and eventually onto the market.

About the research leaders

Dr. Gail Eckhardt has been the principal investigator on over 40 Phase I/II trials and co-investigator on a further 50 experimental drug trials. She is widely recognized as a leading researcher in cancer and the role of angiogenesis (blood vessel formation) in cancer.

Dr. Rene Gonzalez, associate professor at the CUHSC and a well-established melanoma specialist involved in multiple melanoma clinical trials, will assist Dr. Eckhardt with the Phase II trial.

About Progen

Progen Industries is a biotechnology company committed to the discovery, development and commercialisation of small molecule pharmaceuticals for the treatment of a variety of diseases for which there is a significant demand for new therapies. The company's lead drug candidate, PI-88, is under development as a potential treatment for cancer and cardiovascular disease.

The company's drug discovery efforts are focused on the development of potent, selective inhibitors of carbohydrate-protein interactions, which are implicated in a range of different diseases. The company has a world-class facility that manufactures drug candidates under Good Manufacturing Practices (GMP) for clinical trials.

Progen Industries is collaborating with internationally respected researchers. A collaboration with Professor Mark von Itzstein from Australia's Griffith University has been established to develop inhibitors of the enzyme heparanase.

For more information, visit http://www.progen.com.au or call 415/776-6499.
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Comment:PROGEN'S FIRST U.S. CLINICAL TRIAL WITH PI-88 BEGINS.
Publication:Worldwide Biotech
Geographic Code:8AUST
Date:Sep 1, 2001
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