Cardio3 BioSciences Receives Approval for the Continuation of Its CHART-1 Phase III Clinical Trial from the DSMB
September 15 2014 - 6:55AM
Business Wire
The DSMB (Data Safety and Monitoring Board),
a committee composed of international independent experts,
unanimously recommends continuing the study according to the
original protocol, after having analyzed safety data relating to
C-Cure® and C-Cathez® in the ongoing Phase III
clinical trial conducted in Europe and Israel
Cardio3 BioSciences SA (C3BS) (Paris:CARD) (Brussels:CARD) (NYSE
Euronext Brussels and NYSE Euronext Paris: CARD), leader in the
discovery and development of regenerative, protective and
reconstructive therapies for the treatment of cardiac diseases,
today announces it has received the recommendation of the Data
Safety and Monitoring Board (DSMB) to continue the CHART-1 clinical
trial according to the original protocol. The recommendation is
based on a planned analysis performed on all patient safety data
available as per mid-August 2014.
The Data Safety and Monitoring Board is an independent committee
composed of independent international experts in charge of safety
evaluation of C-Cure® and C-Cathez® in the CHART-1 Phase III
clinical trial currently underway in several countries in Europe
and in Israel. The DSMB analyzed safety data 1-month post treatment
of all patients randomized in the trial.
The CHART-1 (Congestive Heart failure
Cardiopoietic Regenerative Therapy) trial
represents the world’s first Phase III trial for a pre-programmed
cellular therapy for the treatment of heart failure.
The members of the DSMB approved unanimously the continuation of
the trial having concluded that one month post treatment, C-Cure®
and C-Cathez® shows no safety issue that compromises the
continuation of the CHART-1 Phase III study.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We
are very pleased by the unanimous recommendation of the DSMB to
continue to pursue CHART-1. This planned analysis is a significant
step in our Phase III program and the positive outcome confirms all
the confidence placed in the trial by our partners and investors.
CHART-1 continues to progress well and the positive view of the
DSMB will add further impetus to recruitment which we look forward
to completing on schedule by the end of 2014.”
The Phase III trial is a prospective, multi-centre, randomized,
sham-controlled, patient-and evaluator-blinded study comparing
treatment with C-Cure® 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 nine months
post-procedure.
*** END ***
If you want to subscribe to the company newsletter, please fill
in the subscription form on the website www.c3bs.com
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 C-Cure®
is an innovative pharmaceutical product that is being developed for
heart failure indication. C-Cure® consists of a patient’s own cells
that are harvested from the patient’s bone marrow and engineered to
become new heart muscle. This process is known as
Cardiopoiesis.Cardio3 BioSciences has also developed
C-Cath®ez, the most technologically advanced injection catheter
with superior efficiency of delivery of bio therapeutic agents into
the myocardium.Cardio3 BioSciences’ shares are listed on Euronext
Brussels and Euronext Paris under the ticker symbol CARD.
C3BS-CQR-1, C-Cure, C-Cathez, Cardio3 BioSciences and the
Cardio3 BioSciences and C-Cathez 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.
Cardio3 BioSciencesDr Christian Homsy, CEOJulie Grade,
Corporate Communication ManagerTel : +32 10 39 41
00www.c3bs.comorCitigate Dewe RogersonChris Gardner,
Tel : +44 (0) 207 638 9571
Takung Art (AMEX:TKAT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Takung Art (AMEX:TKAT)
Historical Stock Chart
From Jul 2023 to Jul 2024
