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Cardio3 BioSciences Completes Patient Enrolment in First Stage of Pivotal Trial of C-Cure(R) in Heart Failure

Wednesday, December 16, 2009 Heart Disease News J E 4
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MONT-SAINT-GUIBERT, Belgium, December 15

- 45 Patients Enrolled in Study Designed to Evaluate the Ability ofCardiopoietic Cells to Restore Cardiac Function

Cardio3 BioSciences, a leading Belgian biotechnology company specialisingin cell-based therapies for the treatment of cardiovascular diseases,announced today that it has completed, two months ahead of schedule,enrolment in the first stage of its pivotal Phase II/III trial of C-Cure, aunique stem cell therapy for heart failure. Forty-five patients have nowenrolled in the study which is being conducted at centres in Belgium andSerbia. The C-Cure trial will ultimately enroll 240 patients making it one ofthe largest randomized trials in regenerative therapies for heart failure.

C-Cure is produced by taking a patient's own bone marrow cells and,through a proprietary process, differentiating them into cardiopoietic cellsthat can regenerate damaged heart muscle. The cardiopoietic cells areinjected into the heart of a patient with heart failure where they aredesigned to behave identically to those cells lost in heart failure withoutcarrying the risk of rejection, something that has not been achieved withprevious cell therapies for this indication. C-Cure is the outcome ofmultiple years of research conducted at Mayo Clinic (Rochester, Minnesota,USA) and at the Cardiovascular Center in Aalst (Aalst, Belgium).

Safety data from this stage of the trial is expected to be available inMay 2010. The second stage, which will recruit 195 further patients isexpected to start in the third quarter of 2010 and involve further sites inEurope and in the United States. The trial design is a randomized,prospective, multi-center trial, to evaluate the safety and efficacy ofC-Cure beyond optimal clinical care in patients with heart failure. The trialwill also evaluate socio-economic implications of therapy.

Dr Christian Homsy, CEO of Cardio3 BioSciences said: "We believe C-Cureholds the promise for a treatment that could fundamentally change the futureof heart failure patients, one of the world's greatest medical needs. Thefact that we have been able to fully enroll the first stage of the trial twomonths ahead of schedule speaks to the interest physicians have in thispotential new therapy and brings us a step nearer a new treatment for acondition where at present current therapy does not address the underlyingcause of the disease."

Heart failure is a serious and common condition in which the heart cannotpump enough blood through the body, leaving the patient debilitated andunable to conduct a normal life. It can result from heart attacks or a numberof other causes. Patients suffering from the condition can experienceshortness of breath and extreme exhaustion. It affects 20 million patients inEurope, US and Japan and this number is predicted to double by 2020.Therapies available for chronic heart failure aim at slowing down the diseaseprogression, but with the exception of heart transplant, existing drugs ordevices do not cure chronic heart failure.

Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center inAalst, Belgium and Co-Principal Investigator of the C-Cure trial commented:"C-Cure represents a major breakthrough in the field of cardiac regenerativemedicine offering the potential of a curative treatment which could savelives and avoid the need for heart transplants. The trial is progressing verywell and we look forward to seeing the safety data next year and to beginningthe larger second stage to fully examine the efficacy of C-Cure for thesepatients."

About Cardio3 BioSciences

Cardio3 BioSciences is a leading Belgian biotechnology companyspecialising in stem cell-based therapies for the treatment of cardiovasculardisease. The Company's lead product, C-Cure, is a highly innovative approachto the treatment of heart failure, one of the world's most pressing unmetmedical needs. Based on a strategy developed by Cardio3 BioSciences' foundersand leveraging technology from Mayo Clinic, C-Cure allows the differentiationof a patient's own cells into cardiopoeitic cells which grow into new heartcells and repair heart muscle.

The Cardio3 BioSciences team has extensive experience in developing andcommercialising new pharmaceutical products and medical technologies and theCompany's strategy is to drive the clinical development of C-Cure and tomarket the product itself in major territories.

Cardio3 BioSciences was founded in July 2007 and is based inMont-Saint-Guibert in the Walloon region of Belgium.

Disclosures

Mayo Clinic has a financial interest in technology related to thisresearch and may stand to gain from the successful outcome of the research.Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectualproperty licensed to the company.For more information contact: Cardio3 BioSciences: Dr Christian Homsy, CEO, Tel: +32-10-39-41-00, chomsy@c3bs.com . Mayra Beydoun, Brand & Communication Manager, Tel : +32-10-39-41-00, mbeydoun@c3bs.com . http://www.c3bs.com Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, Tel : +44(0)207-638-9571, chris.gardner@citigatedr.co.uk .

SOURCE Cardio3 BioSciences
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