Despite significant therapeutic advances, heart failure remains the predominant cause of mortality in the Western world. Ischaemic cardiomyopathy and myocardial infarction are typified by the irreversible loss of cardiac muscle (cardiomyocytes) and vasculature composed of endothelial cells and smooth muscle cells, which are essential for maintaining cardiac integrity and function. The recent identification of adult stem cells has triggered attempts to directly repopulate these tissues by stem cell transplantation as a novel therapeutic option. Reports describing provocative and hopeful examples of myocardial regeneration with adult bone-marrow-derived stem and progenitor cells have increased the enthusiasm for the use of these cells.

Biogenea - Cellgenea Ltd's scientific people is now focusing on current preclinical and clinical advances in bone-marrow-derived stem or progenitor cell therapies for regeneration or repair of the ischemic myocardium and their multiple related mechanisms involved in myocardial repair and regeneration. Biogenea-Cellgenea Ltd will now produces cell suspensions and advanced medicinal stem cell products containing a synergetic stem cell population and a combination of Bone marrow-derived mesenchymal stem cells, mononuclear cells, and circulating endothelial progenitor both for the treatment of heart diseases.

Biogenea-Cellgenea Ltd is planning to commence a Phase I clinical trial evaluating the safety of Cardiogenea administration in the treatment of acute myocardial infarction (AMI).

This first step will allow commencement of the second clinical study for Cardiogenea, a proprietary stem cell product candidate, and its first trial in the cardiovascular disease area. The company believes that Cardiogenea may have broad potential in a number of clinical areas based on its multiple mechanisms of action, its potential to be used "off-the-shelf" like a pharmaceutical product, and the safety and benefit demonstrated in preclinical studies by the company and its collaborators.

Today's effort represents another milestone for the company and for the Cardiogenea program. We believe that Cardiogenea has the potential to significantly enhance the treatment of heart attacks and other ischemic disorders and also o improve the quality of life of thousand patients. We look forward to exploring its safety and functionality in treating acute myocardial infarctions as well as other serious medical conditions.

The Phase I study will be an open label, multi-centre dose clinical trial evaluating the safety and maximum tolerated dose of multiple stem cell doses administration of Cardiogenea following an AMI. Following standard treatment, enrolled patients will receive Cardiogenea delivered via a micro-infusion catheter. These patients will then be evaluated and compared to patients receiving standard-of-care only.