MONT-SAINT-GUIBERT, Belgium, April 12, 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 that it has been granted Good Manufacturing Practice (GMP) Certification for its new production facilities in Mont-Saint-Guibert. Certification was granted by the Federal Agency for Medicines and Health Products (FAMHP), the authority responsible for the quality, safety and efficacy of medicines and health products in Belgium.
GMPs are regulatory requirements that provide guidelines for necessary processes, procedures and documentation to assure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use. The FAMHP inspected Cardio3 BioSciences' Mont-Saint-Guibert facilities to certify such continued compliance.
The Mont-St-Guibert production facilities are used in the manufacture and testing of Cardio3 BioSciences' lead product C3BS-CQR-1, a regenerative therapy currently in development for the treatment of heart failure. C3BS-CQR-1 is expected to enter a Phase III study in 2012.
Dr Christian Homsy, CEO of Cardio3BioSciences, said: "We've followed GMP guidelines from the start of our activities and are very pleased to have demonstrated, via this recent audit and registration and also our recent ISO certification for our cardiac catheter work, our continuing commitment to quality practices. Gaining GMP certification from the health authorities is also a key step for Cardio3 BioSciences ahead of our planned Phase III trial for C3BS-CQR-1, a product we believe offers a potentially revolutionary new approach for the treatment of heart failure, one of the world's most significant unmet medical needs."
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 Center Aalst, Belgium.
The Company's lead product candidate C3BS-CQR-1 is an innovative pharmaceutical product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis, a process to mimic in adult stem cells the natural signals triggered in the early stages of life during the cardiac tissue development. Cardio3 BioSciences has developed C-Cath®, the next-generation 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 http://www.c3bs.com Dr Christian Homsy, CEO Tel: +32(10)39-41-00 Anne Portzenheim, Communication Manager [email protected] Citigate Dewe Rogerson Tel : +44(207)638-9571 Chris Gardner/Nina Enegren [email protected] Hill & Knowlton Tel : +32(2)737-95-00 Katia Delvaille [email protected]
SOURCE Cardio3 BioSciences