Cardio3 BioSciences Receives Authorization to Enroll Patients in Sweden in its Phase III Clinical Trial CHART-1
June 10 2014 - 11:35AM
Business Wire
- CHART-1 trial represents the world’s
first Phase III trial in regenerative medicine for a pre-programmed
cellular therapy targeting heart failure
- To date, ten countries have granted
authorization for Cardio3 BioSciences’ Phase III (CHART-1)
Cardio3 BioSciences SA (C3BS) (Paris:CARD) (Brussels:CARD),
leader in the discovery and development of advanced regenerative
therapies for heart disease, today announces it has received
authorization from the Swedish Medical Products Agency
(LÄKEMEDELSVERKET) to begin its Congestive Heart failure
Cardiopoietic Regenerative Therapy (CHART-1) European Phase III
trial for C-Cure® in Sweden.
After the recent authorization in Ireland, and earlier in United
Kingdom, Belgium, Israel, Serbia, Hungary, Spain, Italy, Poland and
Ireland, Sweden is the tenth country to have authorized this unique
study, which aims to treat ischemic congestive heart failure.
The CHART-1 trial (Congestive Heart failure
Cardiopoietic Regenerative Therapy) represents
the world’s first Phase III trial for a pre-programmed cellular
therapy for the treatment of heart failure.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We
are very pleased with the progress of our Phase III clinical study.
Adding another European country will enable us to pursue the
CHART-1 study according to our objectives."
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 9 months
post-procedure.
*** END ***
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 USA 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
regenerate the heart. This process is known as Cardiopoiesis.
Cardio3 BioSciences has also developed C-Cathez®, the most
technologically 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-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.
Cardio3 BioSciencesDr Christian Homsy, CEOTel : +32 10 39
41 00Anne Portzenheim, Communication
Manageraportzenheim@c3bs.comwww.c3bs.comorCitigate
Dewe RogersonChris GardnerTel : +44 (0) 207 638 9571
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