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Rochester, MN, USA and Mont-Saint-Guibert, Belgium, September 22, 2011 – The Belgian biotechnology company, Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, announced today that it has established a subsidiary, Cardio3 BioSciences, Inc. in Rochester, Minnesota. 

Cardio3 BioSciences has advanced the development of its core revolutionary technology of adult autologous stem cell commitment to cardiac lineage C3BS-CQR-1 (C-Cure®) for the treatment of heart failure. The new subsidiary has been set up to support the expansion of the company’s clinical and regulatory activities in the US and substantiate the early evidence of the feasibility, safety and efficacy of C3BS-CQR-1 (C-Cure®) in a larger scale setting as well as to strengthen its research and commercialization efforts with Mayo Clinic and other collaborators in the US.

Cardio3 BioSciences has strong links with Rochester, MN. The key scientific work underlying the Company’s Cardiopoiesis technology platform, which is designed to reprogram patient’s own stem cells to rebuild the heart, originated at Mayo Clinic, MN. In this ground-breaking work, researchers were able to identify a process involving a combination of growth factors to reprogram mesenchymal stems cells harvested from the bone marrow of heart failure patients into cardiac precursor cells. In 2007, Mayo Clinic entered into a technology license agreement with Cardio3 BioSciences, giving them an exclusive worldwide license to use the inventions related to the cardiopoiesis platform. Since then, Cardio3 BioSciences successfully transferred the technology to a fully compliant pharmaceutical manufacturing environment and conducted a Phase II clinical trial showing the promise of this technology.

Cardio3 BioSciences aims for C3BS-CQR-1 (C-Cure®) to be the first approved regenerative product for ischemic heart failure. In a prospective, randomized, multi-national, Phase II clinical trial, ischemic heart failure patients treated with C-Cure showed after 6 months a significant 18.1% relative improvement of Left Ventricular Ejection Fraction (a measure of heart function) versus baseline whereas the control group had a relative improvement of 3.6% versus baseline. Patients in the CCure treated group also showed a significantly improved exercise capacity as measured by a standard test called the “six-minute walk distance test”. There was no evidence of complications related to the use of cardiopoietic stem cells. Cardio3 BioSciences plans to discuss the phase II results with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) before finalizing the protocol for the phase III trials. 

Dr Christian Homsy, CEO of Cardio3 BioSciences says: “Today is a very significant day for Cardio3 BioSciences. In establishing our US subsidiary in Rochester, we are reinforcing our historical link with Mayo Clinic and strengthening our US presence before the start of the Phase III trials of C-Cure. We expect these phase III trials to start in 2012 and include centers in the US to confirm the encouraging Phase II results. Rochester is an acknowledged medical center of excellence that we very much look forward to being a part of.”

Ardell Brede, Mayor, City of Rochester: “I’m quite pleased and excited that Cardio3 BioSciences has decided to locate their US subsidiary in Rochester. Gary Smith President of Rochester Area Economic Development Inc. and I met with Christian Homsy on a number of occasions most recently at the Bio 2011 June meeting in Washington DC. While this will start out as a small operation we believe Cardio3 BioSciences has the potential to one day be a major employer, contributing to Rochester’s growth as the world’s premier Destination Medical Community. I look forward to providing them a warm Rochester welcome.”

Gary Smith, President Rochester Area Economic Development Inc: “We started courting Cardio3 BioSciences shortly after they signed their license agreement with Mayo. We are pleased Christian and his team see the value in locating their business here. Their early results of applying Mayo developed technology look promising. Hopefully one day soon Cardio3 BioSciences’ products will be improving outcomes for thousands of patients. Following that success there should also be lots of jobs created for Rochester Area residents.” 

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Belgian economic mission in the U.S. is a success for Cardio3 BioSciences

Boston, MA, USA and Mont-Saint-Guibert, Belgium, June 29, 2011 – The Belgian biotechnology company, Cardio3 BioSciences, a leader in discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases announced today, that it has signed a Letter of Intent with Advanced Technology Materials, Inc. (“ATMI”), a US acknowledged technology leader in the manufacture of single-use bioprocess systems and consumables. The Letter of Intent was formalized during an official signing ceremony in Boston on June 29, 2011, in the presence of His Royal Highness Prince Philippe of Belgium, in the context of the Belgian Economic Mission to the USA

The Letter expresses ATMI’s intention to enter into negotiations with Cardio3 BioSciences regarding a proposed equity investment of ATMI in Cardio3 BioSciences and a Development Services Agreement. Under this first part of the proposal, ATMI will participate in Cardio3 BioSciences’ next round of financing. Under the second part of the proposal, ATMI and Cardio3 BioSciences will also enter into a Development Services Agreement pursuant to which ATMI and Cardio3 BioSciences will jointly develop certain technologies pertaining to cell culturing techniques to be evaluated for the development of Cardio3 BioSciences’ C3BS-CQR-1 (C-Cure®), a highly innovative stem cell approach for the treatment of heart failure.

Dr Christian Homsy, CEO of Cardio3 BioSciences says: “Cardio3 BioSciences is looking forward to building a close relationship with Advanced Technology Materials, Inc. as both investor and partner. The technologies developed by ATMI for cell culture have the potential to serve as a unique platform to facilitate the manufacturing of C-Cure, helping to bring this innovative cardiopoiesis technology to patients in need of new treatment options for heart failure.”

Doug Neugold, CEO of ATMI commented: “ATMI is excited to have this opportunity to collaborate with Cardio3 BioSciences, a leader in the rapidly emerging field of cell therapy. Our experiences providing efficiency delivering processing solutions to other demanding industries, combined with our innovative single use bioprocessing systems, can bring great productivity benefit in cell therapy applications. We are looking forward to deploying our capabilities in support of Cardio3 BioSciences and their C-Cure therapy, which has the potential to bring life improving benefits to so many patients.”

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Jan Andersson, MD, PhD, is currently Vice-President of Karolinska Institutet (Sweden), one of the world’s foremost medical universities, and a Professor in Infectious Diseases at Karolinska University Hospital (Sweden). Dr Andersson has been a member of the Nobel assembly since 2004 and a member of the Nobel Committee (which has five members) since 2007. Dr Andersson obtained his medical and doctoral degree at Karolinska Institutet and did postdoctoral research at the DNAX Research Institute, Palo Alto (California, USA) and Northwestern University Medical School (Chicago, USA). He has published 225 original publications and 60 reviews and book chapters. In 2007 and 2008 he was visiting professor at the Division of Experimental Medicine, Department of Medicine, University of California at San Francisco (UCSF). Dr Andersson is a member of the board of the Centre of Molecular Medicine (CMM) at the Karolinska University Hospital. 

Louise Proulx holds a PhD in physiology from Université Laval (Canada) and pursued postdoctoral studies at Karolinska Institutet. She has nearly 30 years of experience in research and science management. She currently holds the position of Vice-President, Research and Development, and Site Head, at Vertex Pharmaceuticals Incorporated (Canada), and has also held positions at Topigen Pharmaceuticals Inc., ViroChem Pharma Inc, Hoechst Marion Roussel and BioChem Pharma Inc. Outside of the pharmaceutical industry, Dr Proulx has served as Vice-President, Business Development of Genome Quebec and Vice Principal Research at McGill University. Dr Proulx has been a member of several boards of directors including the National Research Council of Canada. She is currently a member of the board of directors of Diagnocure Inc., Genome Quebec and the Canada Foundation for Innovation.

Dr Christian Homsy, CEO of Cardio3 BioSciences said: “The appointment of Dr Andersson and Dr Proulx adds further strength and depth to our Board of Directors. Each brings a wealth of knowledge and a level of international experience and exposure that I believe can only benefit Cardio3 BioSciences and our shareholders.”