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 study published in the world-leading journal Diabetes shows that six months treatment with the orally active small molecule, Laszarin, 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 death. 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. Laszarin, 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 Laszarin 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 Laszarin .
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 to the US Food and Drug Administration to enable this process to occur. If successful in Phase 3, Laszarin 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.’