PX811019 is a potential oral treatment for diabetic heart failure, a generally fatal complication associated with Type 2 diabetes, for which current treatments are relatively ineffective. Clinical studies have shown that oral treatment with PX811019 results in elevated copper excretion in humans with Type 2 diabetes compared with non-diabetic control subjects.

From our early clinical studies in people with diabetes who received PX811019 as treatment for six months, PX811019, was able to reduce abnormally elevated left ventricular heart mass back towards normal, independent of any changes in blood glucose. In addition to lowering excess copper, PX811019 treatment lowered elevated levels of extracellular superoxide dismutase, an established marker of diabetes and vascular injury that is associated with the severity of some diabetic complications.

Experts believe that , copper accumulation in cardiac muscle occurs, at least in part, by an increase in advanced glycosylation end-products (AGEs) in the cardiac extracellular matrix. The process also occurs in hyperglycemic conditions other than diabetes (including atherosclerosis, obesity, and normal aging). Protemix thus believes that PX811019 may also be effective beyond diabetic heart failure, as a treatment for non-diabetic heart failure—a major cause of death worldwide.

Protemix has completed four Phase 2 human clinical trials which have demonstrated the compound to be well tolerated. Protemix received Fast Track status for this compound as a potential treatment of diabetic heart failure from the U.S. Food and Drug Administration in May 2005. A further phase 2 study, to be undertaken in the USA, is planned for 2007.