Cardio3 BioSciences Receives Authorization to Enroll Patients in Italy in its Phase III Clinical Trial CHART-1
MONT-SAINT-GUIBERT, Belgium, October 23, 2013 /PRNewswire/ –
- 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, seven countries have granted authorization for Cardio3 BioSciences' Phase III (CHART-1) - Six leading clinical centers will participate in CHART-1 in Italy
The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the
discovery and development of regenerative, protective and reconstructive therapies for the
treatment of cardiac diseases, today announces it has received authorization from the
Italian Medicines Agency (AIFA) to begin its Congestive Heart failure Cardiopoietic
Regenerative Therapy (CHART-1) European Phase III trial for C-Cure(R) in Italy.
After the recent authorization in Spain, and earlier in United Kingdom, Belgium,
Israel, Serbia and Hungary, Italy is the seventh country to have authorized this unique
study. There will be six leading clinical centers participating to the trial in Italy.
The CHART-1 trial represents the world’s first Phase III trial for a pre-programmed
cellular therapy targeting heart failure.
Professor Marco Metra, the Principal Investigator in Italy commented: “We are proud to
participate in this Phase III trial evaluating the benefit of C-Cure(R) cardiopoietic
cells for the treatment of severe heart failure.We believe that theCHART-1 studyis oneof
the most importantcurrent studieson improving thetreatment of chronicheart failure.We
hopethat this innovativetreatment willimprovethe qualityof life of patientssuffering from
thisprogressiveanddebilitating disease, one of the most importantunmetmedical needs today.
E’ tempo d’iniziare! Anche nel nostro paese! ”
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are verypleased with the
progressof ourPhaseIII clinical study. Adding another bigEuropeancountry likeItaly, which
will open six sites,will enable usto pursue the studyaccording toour development plan.”
The Phase III trial is a prospective, multi-centre, randomized, sham-controlled,
patient-and evaluator-blinded study comparing treatment with C-Cure(R) 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.
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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(R) is an innovative pharmaceutical product
that is being developed for heart failure indication. C-Cure(R) 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(R)ez, the most technologically injection
catheter with superior efficiency of delivery of bio therapeutic agents into the
Cardio3 BioSciences’ shares are listed on NYSE Euronext Brussels and NYSE 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.
For more information contact: Cardio3 BioSciences Dr Christian Homsy, CEO Anne Portzenheim, Communication Manager http://www.c3bs.com Tel: +32-10-39-41-00 firstname.lastname@example.org Citigate Dewe Rogerson Chris Gardner Tel: +44(0)207-638-9571
SOURCE Cardio3 BioSciences