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Cardio3 BioSciences Reports Positive Three-Month Data From its Clinical Trial of C-Cure(R) in Heart Failure
Date:6/29/2010

votal clinical program for C-Cure. Cardio3 BioSciences is continuing to take the steps to bring to patients this 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 trial commented: "C-Cure could represent a major breakthrough in the field of cardiac regenerative medicine offering the potential of a life-saving treatment potentially avoiding the need for heart transplants. This trial represents a "first-in-man" therapy using cells 'programmed' to become heart cells. The early stage data that we have seen are encouraging and provides us with very valuable insights that we can use in the design of larger studies to fully examine the efficacy of C-Cure in heart failure patients."

The current C-Cure study is a randomised, prospective, multi-center trial to evaluate the safety and efficacy of C-Cure beyond optimal clinical care in patients with heart failure. It recruited 45 patients in Belgium and Serbia. The primary end point of the trial is change in left ventricular ejection fraction (a measure of how well the heart is functioning) at six months post treatment.

Using the insights from the trial and input from regulators in Europe and the US, Cardio3 BioSciences is now designing a pivotal clinical trial program for C-Cure expected to start in 2011. With the Phase II stage completed and to allow for potential modifications to the trial protocol, Cardio3 BioSciences will not continue recruitment into the existing trial but will continue to gather all data for the six month analysis.

About Cardio3 BioSciences


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