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GEN News Highlights : Sep 22, 2011

Cardio3 Establishes U.S. Subsidiary in Advance of Phase III Heart Failure Cell Therapy Trial

New subsidiary will also support links with Mayo Clinic, which developed cardiopoietic technology on which firm’s treatments are based.

Belgian cardiac cell therapies firm Cardio3 BioSciences established a U.S. subsidiary in Rochester, MN, to support its clinical and development activities and to bolster existing links with the Mayo Clinic and other U.S. collaborators. Cardio3’s lead product, C3BS-CQR-1 (C-Cure®), is a stem cell-based cardiac lineage in clinical development for the treatment of heart failure. Phase III studies are projected to start in 2012.

Having a base in the U.S. will allow the firm to substantiate early evidence of the feasibility, safety, and efficacy of C-Cure in a larger-scale setting, including Phase III studies, and strengthen its ongoing research and commercialization relationship with the Mayo Clinic, which developed the cardiopoiesis technology on which Cardio3’s platform has been built.

Founded in 2007, Cardio3 is focused on the development of regenerative and protective therapies for the treatment of cardiac disease. Lead product candidate C-Cure is based on a patient’s own bone marrow stem cells, which are treated with a cardiopoietic cocktail before being re-injected into the heart to generate heart muscle cells. The firm says the treatment acts both directly, through the proliferation, engraftment, and terminal differentiation of the injected cells, as well as indirectly, through the beneficial effect on the patient’s existing cardiac stem cells of factors secreted by the transplanted cells.

Positive six-month data from a Phase II trial in heart failure patients were reported in November 2010. The study, in Belgium, Serbia, and Switzerland, showed that patients treated using C-Cure in addition to standard care demonstrated significant increases in left ventricular ejection fraction over and above those treated in the control group. Data also suggested that the treatment led to favorable heart muscle remodeling, improved heart muscle performance, and led to improved fitness. Bone marrow from 70% of 30 patients was successfully processed into C-Cure; Cardio3 says it aims to increase this to 80% in its Phase III clinical program.