Mayo linked heart regeneration biotech touts good data
Cardio3, a
Belgium-based biotech firm that licenses Mayo Clinic research, is touting the results from the first three months of the clinical trial of its regenerative heart treatment in humans.
Using stem cells from a patient's bone marrow, this company treats cardiac problems by regenerating heart tissue with a therapy called C-Cure.
Here's some from the announcement released Tuesday.
Results showed C-Cure to have a very good safety profile with no adverse events related to C-Cure, as assessed by an independent board. The study is also examining a number of measures of efficacy.
With three month follow up data in-hand, Cardio3 BioSciences has observed positive and encouraging trends in a number of physiological
and clinical parameters.
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Cardio3 Biosciences intends to publish the study results once the full six month dataset is available and has been analysed.
Dr Christian Homsy, CEO of Cardio3 BioSciences said: "The data so far from our trial is very encouraging. We showed that C-Cure is safe at three months. We also saw positive trends in other measures that suggest that C-Cure, as anticipated from animal model data, is acting on heart muscle in a way that could yield important clinical benefits. We now look forward to seeing the full six-month follow-up data and completing the analysis of the trial."
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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.
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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.

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