Cardio3 BioSciences Reports Positive Three-Month Data From its Clinical Trial of C-Cure(R) in Heart Failure
By Cardio3 Biosciences, PRNEMonday, June 28, 2010
MONT-SAINT-GUIBERT, Belgium, June 29, 2010 - Cardio3 BioSciences, a leading Belgian biotechnology company specialising
in regenerative therapies for the treatment of cardiovascular diseases, today
announces positive safety data and preliminary efficacy results from its
clinical trial of C-Cure(R), a breakthrough stem cell therapy for heart
failure.
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. Meaningful
differences were seen in ventricular size, ejection fraction and other
measures of heart muscle activity in C-Cure treated patients when compared to
control and to baseline. Partial data from a paired analysis of patients at
six-months follow-up is suggestive of these beneficial trends being
reinforced over time. 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."
"With the confidence and experience gained from this trial, we are moving
ahead with finalizing the design of our pivotal clinical program for C-Cure.
Cardio3 BioSciences is continuing to take the steps to bring to patients this
new treatment for a condition where current therapies do not address the
underlying cause of the disease."
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.
The primary end point of the trial is change in left ventricular ejection
fraction (a measure of how well the heart is functioning) at six months post
treatment.
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. With the Phase II stage completed and
to allow for potential modifications to the trial protocol, Cardio3
BioSciences will not continue recruitment into the existing trial but will
continue to gather all data for the six month analysis.
About Cardio3 BioSciences
Cardio3 BioSciences is a leading Belgian biotechnology company
specialising in regenerative therapies for the treatment of cardiovascular
disease. The Company's lead product, C-Cure(R), 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 licensed from Mayo Clinic, C-Cure is
designed to reprogram the patient's own stem cells into new heart cells to
rebuild the heart.
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.
About C-Cure and Heart Failure
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 28
million patients worldwide 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.
C-Cure is produced by taking a patient's own stem 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).
For more information contact:
Cardio3 BioSciences Dr Christian Homsy, CEO Tel: +32-10-39-41-00 Anne Portzenheim, Communication Manager Tel : +32-10-39-41-00 aportzenheim@c3bs.com www.c3bs.com Citigate Dewe Rogerson Chris Gardner/Nina Enegren Tel : +44(0)207-638-9571 chris.gardner@citigatedr.co.uk Hill & Knowlton Tel : +32-2-737-95-00 Katia Delvaille kdelvail@hillandknowlton.com
Cardio3 BioSciences, Dr Christian Homsy, CEO, Tel: +32-10-39-41-00; Anne Portzenheim, Communication Manager Tel : +32-10-39-41-00, aportzenheim at c3bs.com; Citigate Dewe Rogerson, Chris Gardner/Nina Enegren, Tel : +44(0)207-638-9571, chris.gardner at citigatedr.co.uk; Hill & Knowlton, Tel : +32-2-737-95-00, Katia Delvaille, kdelvail at hillandknowlton.com
Tags: belgium, Cardio3 BioSciences, June 29, Mont-saint-guibert