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Clinical Center of Serbia, Institute for Cardiovascular Diseases Treats First Patient in Trial of Pioneering Stem Cell-Derived Therapy for Heart Failure

Friday, October 16, 2009 General News J E 4
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BELGRADE, Serbia, October 16 --

- Clinical Trial Designed to Evaluate the Ability of Cardio3Biosciences' C-Cure(R) to Restore Heart Function

Clinical Center of Serbia, Institute for Cardiovascular Diseases today announced that it has treated its first patient with a revolutionary cell-based therapy for heart failure. The patient is participating in an international trial of C-Cure(R), a second generation cell therapy developed by Cardio3 BioSciences, a leading Belgian biotechnology company specializing in stem cell-based therapies for the treatment of cardiovascular disease.

C-Cure is produced by taking a patient's own bone marrow cells and, through a proprietary process, differentiating them into 'cardiopoietic' cells that can regenerate damaged heart muscle. The 'cardiopoietic' cells are injected into the heart of a patient with heart failure where they are designed to behave identically to those cells lost in heart failure without carrying the risk of rejection, something that has not been achieved with previous cell therapies for this indication.

Heart failure is a serious and common condition in which the heart cannot pump enough blood through the body, leaving the patient debilitated and unable to conduct a normal life. It can result from heart attacks or a number of other causes. Patients suffering from the condition can experience shortness of breath and extreme exhaustion. It affects 20 million patients in Europe, US and Japan. Therapies available for chronic heart failure aim at slowing down the disease progression, but with the exception of heart transplant, existing drugs or devices do not cure chronic heart failure.

The trial, a randomized, prospective, multi-center trial, is designed to evaluate the safety and efficacy of C-Cure beyond optimal clinical care in patients with heart failure. Patients will be randomized to C-Cure in addition to optimal standard therapy versus optimal standard therapy alone. The trial will also evaluate socio-economic implications of therapy. The trial is being carried out at various sites in the European Union, and now Serbia.

Dr. Jozef Bartunek, Co-Principal Investigator for the trial commented: "C-Cure is a major breakthrough in the field of cardiac regenerative medicine. This clinical trial will be the very first to apply autologous, guided cardiac progenitor cells. This next generation stem cell product could contribute to the physical and functional regeneration of cells in the chronically infarcted heart."

Pr. Miodrag Ostojic, Principal Investigator for the trial in the Clinical Center of Serbia, Institute for Cardiovascular Diseases said: "Heart failure is one of the greatest causes of premature death in the world and we are very pleased to be participating in the trial of a product that could potentially transform the treatment of the condition and the outcome for patients."

About Cardio3 BioSciences

Cardio3 BioSciences is a leading Belgian biotechnology company specialising in stem cell-based therapies for the treatment of cardiovascular disease. The Company's lead product, C-Cure, is a highly innovative approach to the treatment of heart failure, one of the world's most pressing unmet medical needs. Based on a strategy developed by Cardio3 BioSciences' founders and leveraging technology from Mayo Clinic, C-Cure allows the differentiation of a patient's own cells into 'cardiopoeitic' cells which grow into new heart cells and repair heart muscle.

The Cardio3 BioSciences team has extensive experience in developing and commercialising new pharmaceutical products and medical technologies and the Company's strategy is to drive the clinical development of C-Cure and to market the product itself in major territories. Cardio3 BioSciences was founded in July 2007 and is based in Mont-Saint-Guibert in the Walloon region of Belgium.

Disclosures

Mayo Clinic has a financial interest in technology related to this research and may stand to gain from the successful outcome of the research. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company.

About Clinical Center of Serbia, Institute for cardiovascular diseases

The Clinical Center of Serbia represents the top of the tertiary healthcare system in Serbia. It consists of 22 institutes and five centers, which cover all fields of clinical medicine for the adult population. The Division of Cardiology of the Clinical Center of Serbia is the leading center for interventional cardiology in country, with approximately 1000 primary percutaneous coronary interventions (PCIs) per year and additional 1200 elective cases per year. As far as medical care, the Institute for Cardiovascular Diseases treats patients with various cardiovascular diseases - from infective endocardidis, through heart failure up to implantation of pacemakers and performing coronary angiography and PCIs. The Division of Cardiology is a teaching hospital, an affiliated institution of Medical Faculty of Belgrade, and also conducts postgraduate studies in cardiology.

As far as research work, The Division of Cardiology has conducted studies on programs such as Biomatrix, PK Stealth, PK Nobori, Reality (Taxus Vs. Cypher), Protex, PK Xtent which have served for FDA approval of those devices.

    For more information contact:

    Cardio3 BioSciences

    Dr Christian Homsy, CEO                         Tel: +32-10-39-41-00
    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

    Clinical Center of Serbia, Institute for Cardiovascular Diseases
    Mr. Drago Jovanovic, PR Manager Tel: +381(0)11-3613653


SOURCE Cardio3 BioSciences

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