Cardio3 BioSciences Completes Patient Enrolment in First Stage of Pivotal Trial of C-Cure(R) in Heart Failure
By Cardio3 Biosciences, PRNEMonday, December 14, 2009
45 Patients Enrolled in Study Designed to Evaluate the Ability of Cardiopoietic Cells to Restore Cardiac Function
MONT-SAINT-GUIBERT, Belgium, December 15 - Cardio3 BioSciences, a leading Belgian biotechnology company specialising
in 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, a
unique stem cell therapy for heart failure. Forty-five patients have now
enrolled in the study which is being conducted at centres in Belgium and
Serbia. The C-Cure trial will ultimately enroll 240 patients making it one of
the 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
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. C-Cure is the outcome of
multiple 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 in
May 2010. The second stage, which will recruit 195 further patients is
expected to start in the third quarter of 2010 and involve further sites in
Europe and in the United States. The trial design is a randomized,
prospective, multi-center trial, to evaluate the safety and efficacy of
C-Cure beyond optimal clinical care in patients with heart failure. The trial
will also evaluate socio-economic implications of therapy.
Dr Christian Homsy, CEO of Cardio3 BioSciences said: "We believe C-Cure
holds the promise for a treatment that could fundamentally change the future
of heart failure patients, one of the world's greatest medical needs. The
fact that we have been able to fully enroll the first stage of the trial two
months ahead of schedule speaks to the interest physicians have in this
potential new therapy and brings us a step nearer a new treatment for a
condition where at present current therapy does not address the underlying
cause of the disease."
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 and this number is predicted to
double by 2020. 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.
Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center in
Aalst, Belgium and Co-Principal Investigator of the C-Cure trial commented:
"C-Cure represents a major breakthrough in the field of cardiac regenerative
medicine offering the potential of a curative treatment which could save
lives and avoid the need for heart transplants. The trial is progressing very
well and we look forward to seeing the safety data next year and to beginning
the larger second stage to fully examine the efficacy of C-Cure for these
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.
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 . www.c3bs.com Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, Tel : +44(0)207-638-9571, chris.gardner@citigatedr.co.uk .
For more information contact: Cardio3 BioSciences: Dr Christian Homsy, CEO, Tel: +32-10-39-41-00, chomsy at c3bs.com . Mayra Beydoun, Brand & Communication Manager, Tel : +32-10-39-41-00, mbeydoun at c3bs.com . www.c3bs.com Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, Tel : +44(0)207-638-9571, chris.gardner at citigatedr.co.uk .
Tags: belgium, Cardio3 BioSciences, Mont-saint-guibert