Cardio3 BioSciences Announces Results of the C-Cure(R) Phase II Clinical Trial at the 60th Annual American College of Cardiology MeetingBy Cardio3biosciences, PRNE
Monday, April 4, 2011
Positive Results for Innovative Heart-Specified Stem Cell Therapy Underscores Generalized Therapeutic Benefit in Heart Failure
MONT-SAINT-GUIBERT, Belgium, April 5, 2011 - The Belgian biotechnology company, Cardio3 BioSciences, a
leader in discovery and development of regenerative and protective therapies
for the treatment of cardiovascular diseases, today presented detailed data
from the Phase II clinical trial of C3BS-CQR-1 (C-Cure(R)), its novel stem
cell therapy for ischemic cardiomyopathy, at the 60th annual American College
of Cardiology in New Orleans, USA.
The data were presented by Dr. Jozef Bartunek, Associate
Director of the Cardiovascular Center in Aalst, Belgium and Co-Principal
Investigator of the C3BS-CQR-1 (C-Cure) trial. The trial demonstrates that
heart failure patients improved heart function and exercise capacity at 6
months following treatment of C-Cure, an innovative and proprietary stem cell
therapy based on the Company's "Cardiopoiesis" technology.
The Cardiopoiesis platform is based on fundamental research
conducted at Mayo Clinic and is designed to drive the differentiation of
adult bone marrow-derived stem cells into cardiac progenitor cells which have
the potential to promote heart regeneration when re-injected into the heart
of patients suffering from ischemic heart failure.
- 45 patients with heart failure secondary to ischemic heart
disease were recruited in Belgium and Serbia, and randomized to optimal
medical care or optimal medical care plus C-Cure treatment. Demographic and
clinical baseline data were similar between 24 controls and 21 patients
treated with C-Cure.
- The study showed that delivery of C-Cure is feasible without
peri-procedural complications. No evidence of cell-induced systemic toxicity
or pro-arrhythmogenicity was observed.
- Cardiac structural and functional parameters, assessed by
echocardiography at six months versus baseline showed the benefit of C-Cure
- On average, left ventricular ejection fraction (LVEF) was significantly augmented over baseline in the C-Cure versus control cohort (5.2 plus or minus 0.6% versus 1 plus or minus 0.7%, p<0.01), translating into a 18.1 plus or minus 2.3% relative increase in systolic function afforded by cell therapy. - Reduction of end-systolic volume was 3-times larger in the C-Cure group compared to the control group (from 171 plus or minus 9 to 150 plus or minus 9mL, and from 167 plus or minus 8 to 159 plus or minus 8mL, p=0.01, respectively). - In contrast to the control cohort, which displayed inter-individual variance, C-Cure treatment invariably led to a pattern of improved left ventricular function in all individuals at 6 months follow-up.
- The beneficial effects on cardiac structure and function in
the C-Cure group translated into meaningful improved fitness. The 6-min walk
test, an index of overall performance, increased from 396 plus or minus 26
at baseline to 449 plus or minus 35 m at six months in C-Cure (+52 plus or
minus 19 m) patients while it decreased from 412 plus or minus 19 to 391
plus or minus 25 m (-21 plus or minus 14 m) in the control group between the
same time points (p<0.01). To summarize, at 6 months post-therapy, C-Cure
treated heart failure patients walked 73 meters more than patients that
received optimal standard of care.
Dr. Jozef Bartunek explained: "Data presented today strongly
suggest that C-Cure is a promising treatment for heart failure, one of the
world's greatest unmet medical needs. A person living to the age of 40 has a
one-in-five risk of developing heart failure and, once the disorder is
apparent, a one-in-three chances of dying within a year of diagnosis. With
the C-Cure trial, we show improved left ventricular and clinical performance
consistent with a generalized therapeutic benefit. Moreover, we proved
feasibility and safety of the C-Cure treatment regimen. The overall signs of
efficacy in C-Cure treated patients are indeed encouraging and open a new
chapter in cardiovascular regenerative medicine."
Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: "Heart
failure affects 117 million people and cannot be cured today as current
therapies only reduce the severity of disease symptoms. Regenerative
therapies, such as C-Cure, may offer new hope to patients who currently have
limited choices and potentially avoid the need for heart transplantation. The
positive outcome of this study reiterates our belief that C-Cure can make a
real difference to patients suffering from heart failure. Indeed, we are
currently planning the next stages of C-Cure development and are committed to
taking the steps needed to successfully bring this new and important
treatment to patients. With C-Cure, we aim to become the first company with
an approved regenerative product for ischemic heart failure."
About Cardio3 BioSciences
Cardio3 BioSciences is a leading Belgian biotechnology company
focused on the discovery and development of regenerative and protective
therapies for the treatment of cardiovascular disease.
The Company's lead product candidate, C3BS-CQR-1 (C-Cure), is
a highly innovative stem cell approach for the treatment of heart failure,
one of the world's most pressing unmet medical needs. Based on a
comprehensive strategy developed by Cardio3 BioSciences and leveraging
technology licensed from Mayo Clinic, the C-Cure development programme is
designed to direct the patient's own stem cells into new heart cells with the
potential 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 current strategy is to drive the clinical
development of C-Cure and to market the product itself, if marketing
authorisation is obtained, on a wide geographical scale.
Cardio3 BioSciences was founded in July 2007 and is based in
Mont-Saint-Guibert (near Louvain-la-Neuve) in the Walloon region of Belgium.
In accordance with the Bayh-Dole Act, Mayo Clinic has licensed
the technology underlying C-Cure to Cardio3 BioSciences and received an
equity position in the company in the context of the license. Mayo Clinic,
and the inventors of the technology, Drs. Andre Terzic and Atta Behfar, have
a financial interest associated with the technology related to this research.
While no royalties have accrued to date, Mayo Clinic has rights to receive
future royalties which will be shared with Drs. Terzic and Behfar in
accordance with the Mayo Clinic Royalty sharing policy.
Certain statements, beliefs and opinions in this press release
are forward-looking, which reflect the Company's or, as appropriate, the
Company's directors' current expectations and projections about future
events. By their nature, forward-looking statements involve a number of
risks, uncertainties and assumptions that could cause actual results or
events to differ materially from those expressed or implied by the
forward-looking statements. These risks, uncertainties and assumptions could
adversely affect the outcome and financial effects of the plans and events
described herein. A multitude of factors including, but not limited to,
changes in demand, competition and technology, can cause actual events,
performance or results to differ significantly from any anticipated
development. Forward looking statements contained in this press release
regarding past trends or activities should not be taken as a representation
that such trends or activities will continue in the future. As a result, the
Company expressly disclaims any obligation or undertaking to release any
update or revisions to any forward-looking statements in this press release
as a result of any change in expectations or any change in events,
conditions, assumptions or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or representatives
nor any of its or their parent or subsidiary undertakings or any such
person's officers or employees guarantees that the assumptions underlying
such forward-looking statements are free from errors nor does either accept
any responsibility for the future accuracy of the forward-looking statements
contained in this press release or the actual occurrence of the forecasted
developments. No undue reliance should be placed on forward-looking
statements, which speak only as of the date of this press release.
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 firstname.lastname@example.org www.c3bs.com Citigate Dewe Rogerson Chris Gardner/Nina Enegren Tel : +44(0)207-638-9571 email@example.com Hill & Knowlton Tel : +32-2-737-95-00 Katia Delvaille firstname.lastname@example.org
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 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: April 5, belgium, Cardio3biosciences, Mont-saint-guibert