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Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients
Date:11/17/2010

ther increasing this successful rate to 80% in its Phase III clinical program.

Dr. Christian Homsy, CEO of Cardio3 BioSciences said: "The highly promising data we report today build on the favourable safety profile we have observed through this Phase II trial and documents in patients our belief that we have with C-Cure a product candidate with the potential to make a real difference in the treatment of heart failure. It is important to note that the improvements in heart function suggested by the trial, were identified in the context of a Phase II trial aimed at assessing the safety and feasibility of C-Cure therapy. It is all the more encouraging to have seen significant differences in some key efficacy indicators despite the fact that the study was not powered, in terms of the number of patients, to demonstrate efficacy."

"As noted in the company's press release of 29 June 2010, with the Phase II stage completed and to allow for potential modifications to the trial protocol, Cardio3 BioSciences has not proceeded to Phase III recruitment into the trial but has continued to gather all data for the six month analysis."

"Through the Phase II trial, we gained significant experience in working with a highly innovative stem cell therapy in a clinical setting, and we are using this acquired knowledge in the design of our planned Phase III programme. Cardio3 BioSciences is committed in taking the steps needed to bring to patients a new treatment for a condition where current therapies do not address the underlying cause of the disease."

Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center in Aalst, Belgium and Co-Principal Investigator of the C-Cure Clinical Trial added: "The data reported today are very positive for this 'first in man' trial using stem cells 'directed' to become heart cells. Early efficacy signals are impressive as they come on top of the optimal therapy currently available for patients with heart failure. T
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SOURCE Cardio3 BioSciences
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