Cardio3 BioSciences Receives Authorization to Begin World's First
Phase III Clinical Trial in Regenerative Medicine for Heart Failure
MONT-SAINT-GUIBERT, Belgium,
November 22, 2012 /PRNewswire/ --
The Belgian biotechnology company, Cardio3 BioSciences
(C3BS), a leader in the discovery and development of regenerative
and protective therapies for the treatment of cardiac diseases,
today announces it has received authorization from the Belgian
Federal Agency for Medicines and Health Products (FAMHP) to begin
its Congestive Heart failure Cardiopoietic Regenerative Therapy
(CHART-1) European Phase III trial for C3BS-CQR-1 in Belgium. This represents a world premiere for
a regenerative medicine product targeting heart failure to be
tested in the context of a Phase III trial. C3BS-CQR-1 is an
autologous stem cell therapy for heart failure.
The Phase III trial is a prospective, multi-centre, randomized,
sham-controlled, patient-and evaluator-blinded study comparing
treatment with C3BS-CQR-1 to a sham treatment. The trial will
recruit a minimum of 240 patients with chronic advanced symptomatic
heart failure. The primary endpoint of the trial is a
composite endpoint including mortality, morbidity, quality of life,
Six Minute Walk Test and left ventricular structure and function at
9 months post-procedure.
Studies in additional countries will commence once national
regulatory approvals have been received.
The Cardio3 BioSciences therapy, called C3BS-CQR-1, involves
taking stem cells from a patient's own bone marrow and through a
proprietary process called Cardiopoiesis, re-programming those
cells so that they go onto becoming heart cells. The cells, known
as cardiopoietic cells, are then injected back into the patient's
heart through a minimally invasive procedure using a catheter
called C-Cathez®, with the aim of repairing
damaged tissue and improving heart function and patient clinical
outcomes. C3BS-CQR-1 is the outcome of multiple years of research
conducted at Mayo Clinic (Rochester,
Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert,
Belgium) and Cardiovascular Centre
in Aalst (Aalst, Belgium). This
Phase III trial builds on the successful outcome of the Phase II
trial conducted between 2009 and 2010 in multiple clinical sites in
Belgium, Serbia and Switzerland.
Dr Christian Homsy, CEO of
Cardio3 BioSciences, said: "Heart failure remains a significant
unmet clinical need associated with high morbidity, mortality and
escalating healthcare costs. We believe C3BS-CQR-1 has a potential
to become an alternative to heart transplantation which is the only
curative treatment for heart failure available today. Our Phase III
trial is the first to begin anywhere in the world for a
regenerative therapy for this indication. We look forward to
confirming the promising results we have already seen in our Phase
II study."
Dr Jozef Bartunek, Principal
Investigator, added: "Regenerative therapies have the potential
to revolutionize the treatment of heart disease and other
conditions and we are excited to be working with Cardio3
BioSciences on what is a ground breaking study. The results seen in
the earlier trials were encouraging and if repeated in this larger
study would bring nearer a potentially disruptive treatment for the
expanding epidemic of heart failure."
Cardio3 BioSciences has completed a Phase II trial with
C3BS-CQR-1, which demonstrated that heart failure patients improved
heart function and exercise capacity following treatment compared
to patients receiving current standard of care. Moreover,
feasibility and safety of the C3BS-CQR-1 treatment regimen were
established.
About Cardio3 BioSciences
Cardio3 BioSciences is a Belgian leading biotechnology
company focused on the discovery and development of regenerative
and protective therapies for the treatment of cardiac diseases. The
company was founded in 2007 and is based in the Walloon region of
Belgium. Cardio3 BioSciences
leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular
Centre Aalst, Belgium.
The Company's lead product candidate C3BS-CQR-1 is an innovative
pharmaceutical product that is being developed for heart failure
indication. C3BS-CQR-1 consists of a patient's own cells that
are harvested from the patient's bone marrow and engineered to
become new heart muscle cells that behave identically to those lost
to heart disease. This process is known as Cardiopoiesis.
Cardio3 BioSciences has also developed
C-Cath®ez, the most technologically injection catheter
with superior efficiency of delivery of bio therapeutic agents into
the myocardium.
C3BS-CQR-1, C-Cure, C-Cath, Cardio3
BioSciences and the Cardio3 BioSciences and C-Cath logos are
trademarks or registered trademarks of Cardio3 BioSciences SA, in
Belgium, other countries, or both.
Mayo Clinic holds equity in Cardio3 BioSciences as a result of
intellectual property licensed to the company. In addition to
historical facts or statements of current condition, this press
release contains forward-looking statements, which reflect our
current expectations and projections about future events, and
involve certain known and unknown 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. These forward-looking statements are
further qualified by important factors, which could cause actual
results to differ materially from those in the forward-looking
statements, including timely submission and approval of anticipated
regulatory filings; the successful initiation and completion of
required Phase III studies; additional clinical results validating
the use of adult autologous stem cells to treat heart failure;
satisfaction of regulatory and other requirements; and actions of
regulatory bodies and other governmental authorities. As a result,
of these factors investors and prospective investors are cautioned
not to rely on any forward-looking statements. We disclaim
any intention or obligation to update or review any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For more information contact:
Cardio3 BioSciences
Dr Christian Homsy, CEO
Anne Portzenheim, Communication Manager
www.c3bs.com
Tel : +32-10-39-41-00
aportzenheim@c3bs.com
Citigate Dewe Rogerson
Chris Gardner/Nina Enegren
Tel : +44(0)207-638-9571
nina.enegren@citigatedr.co.uk
Hill & Knowlton
Katia Delvaille
Tel : +32-2-737-95-00
katia.delvaille@hkstrategies.com
SOURCE Cardio3 BioSciences