Protemix corporation announces discovery of way to repair hearts damaged by diabetes

August 30, 2004

Auckland, New Zealand (August 31, 2004): New Zealand biopharmaceutical company Protemix Corporation has announced the discovery of a treatment which appears to reverse heart disease in people suffering from diabetes and may lead to a more effective intervention in a major cause of death worldwide.

A study1 published in the September issue of the world-leading journal Diabetes shows that six months treatment with the orally active small molecule, LaszarinTM, brought about a significant reduction towards normal heart size in diabetic patients with cardiac enlargement.

Diabetes is often accompanied by enlargement and dysfunction of the heart and coronary heart disease and these are major causes of death2. According to the World Health Organisation, over 194 million people have diabetes.

The research led by Professor Garth Cooper and Dr. John Baker of Protemix demonstrates for the first time that defective metabolism of copper in people with diabetes is implicated in the development of heart disease. LaszarinTM, developed in New Zealand by Protemix, removes the excess copper from the body.

The study in preclinical models and in Phase 2 human clinical trials in subjects with type-2 diabetes, showed that LaszarinTM caused increased urinary output of copper compared with treated controls. The researchers found reversed heart failure in preclinical models. They also found that the damaged hearts in the preclinical models and humans had substantively regenerated after treatment with LaszarinTM .

Professor Cooper explained: 'The next step is to investigate this novel treatment, which is the first in its class, in Phase 3 trials in humans. We are currently submitting our Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) to enable this process to occur. If successful in Phase 3, LaszarinTM has a potential worldwide market of over two million people with diabetic heart failure.'

Professor Norman Sharpe, Medical Director, New Zealand Heart Foundation said: 'We hear the word breakthrough all too often, but this is a significant finding for diabetes research, which provides insight into the mechanisms of the disease. There is a distinct possibility for intervention and treatment. This work needs now to be transferred into larger scale clinical trials. It has been assumed since the beginning of time that heart muscle will not regenerate. This work refutes that.'

'This is great news for biotechnology and research in New Zealand. It shows that we can do high quality, international level research in this country. We have the wherewithal, the people and the facilities.'
Professor Harvey White, Director of Coronary Care and Cardiovascular Research, Greenlane Cardiovascular Service at Auckland Hospital commented: 'This is an important contribution from New Zealand which will make the cardiological and diabetic world sit up and take notice. This group has found a treatment, which has now been shown in man to improve the function of the heart. This could have a major impact on the management of diabetes, high blood pressure and coronary artery disease. There is further work to be done and we hope to be part of the team carrying out further studies in man.'

1 Cooper GJS and associates: Regeneration of the Heart in Diabetes by Selective Copper Chelation. Diabetes 53:2501-2508, 2004 2 Struthers AD, Morris AD: Screening for and treating left-ventricular abnormalities in diabetes mellitus: a new way of reducing cardiac deaths. Lancet 359:1430-1432, 2002

Heart disease is the major cause of death in diabetes. According to the American Diabetes Association, more than 65% of people with diabetes die from heart disease or stroke. With diabetes, heart attacks also occur earlier in life and often result in death.

LaszarinTM has been shown in experimental models to significantly alleviate heart failure following seven weeks of treatment, and without lowering blood glucose. It was also shown to substantially improve cardiomyocyte structure, and to reverse elevation in left ventricular collagen and β-1 integrin. Oral treatment with LaszarinTM has been demonstrated to result in elevated copper excretion in humans with type 2 diabetes and, following six months of treatment, caused elevated left ventricular mass to decline significantly toward normal. LaszarinTM has been shown to be well-tolerated by patients in clinical trials to date.

Protemix is a New Zealand biopharmaceutical company with research facilities located within The University of Auckland that develops novel therapies for cardiovascular disease, diabetes mellitus and other metabolic disorders. Protemix was founded in 1999 to commercialise the research of Professor Garth Cooper and Dr John Baker, both internationally recognised researchers with proven records of commercial success. Professor Cooper, Protemix's Chief Executive Officer and Chief Scientific Officer, discovered the peptide hormone amylin and invented amylin replacement therapy for diabetics. Professor Keith Mansford, former Chairman, Research and Development at SmithKline Beecham, is Chairman of the Board of Directors of Protemix. The Company's lead product candidate, LaszarinTM, is a therapeutic copper binding molecule currently being evaluated in late-stage clinical trials for the treatment of heart failure in people with diabetes.

Further information:

David Pool
Protemix Corporation Limited
Ph 64-9-303-5351, 64-21-978-224

U.S. Media Contact:

Joan Kureczka
Kureczka/Martin Associates
Ph 415-821-2413

Kureczka/Martin Associates

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