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

October 16, 2009

BELGRADE, Serbia, October 16 /PRNewswire/ –

– 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

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.


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


    Citigate Dewe Rogerson

    Chris Gardner/Nina Enegren                      Tel : +44(0)207-638-9571

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

SOURCE Cardio3 BioSciences

Source: newswire

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