MONT-SAINT-GUIBERT, Belgium, October 13, 2014 /PRNewswire/ --
Cardio3 BioSciences’ Phase III (CHART-1)
Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies, announces today it has received authorization from Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C-Cure® in Switzerland.
After the recent authorization in Bulgaria, and earlier in Sweden, Ireland, the United Kingdom, Belgium, Israel, Serbia, Hungary, Spain, Italy, and Poland, Switzerland is the 12th 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. Earlier this year, the Company received approval from the DSMB (Data Safety and Monitoring Board) to continue CHART-1 without any changes to the original protocol. The members of the DSMB analyzed safety data 1-month post treatment and unanimously concluded that C-Cure® and
C-Cathez® show no safety issue. Now in the final stages of this clinical trial, and with recruitment continuing to be strong, Cardio3 BioSciences is expected to finalize the recruitment of the last patients towards end of 2014. In parallel, CHART-2, the FDA-approved Phase III clinical trial, will also start around the end of the year.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are approaching the final recruitment phase of our Phase III clinical study for C-Cure® and remain on schedule to finalize recruitment towards end of 2014. The addition of Switzerland in our clinical study is a very positive sign. It is yet another demonstration that ischemic heart failure is an indication for which there is an urgent need for a truly curative therapy. Our hope that C-Cure® will become that therapy is growing every day.”
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.
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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® 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-Cathez®, 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.
For more information, please contact:
Cardio3 BioSciences
Christian Homsy, CEO
Julie Grade, Corporate Communications Manager
http://www.c3bs.com
Tel. : +32-10-39-41-00
jgrade@c3bs.com
Citigate Dewe Rogerson
Chris Gardner
Tel : +44(0)207-638-9571
Chris.Gardner@citigatedr.co.uk
SOURCE Cardio3 BioSciences
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