Cardio3 BioSciences Announces Results of the C-Cure(R) Phase II Clinical Trial at the 60th Annual American College of Cardiology Meeting

MONT-SAINT-GUIBERT, Belgium, April 5, 2011 /PRNewswire/ -- The Belgian biotechnology company, Cardio3 BioSciences, a leader in discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today presented detailed data from the Phase II clinical trial of C3BS-CQR-1 (C-Cure(R)), its novel stem cell therapy for ischemic cardiomyopathy, at the 60th annual American College of Cardiology in New Orleans, USA.

The data were presented by Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center in Aalst, Belgium and Co-Principal Investigator of the C3BS-CQR-1 (C-Cure) trial. The trial demonstrates that heart failure patients improved heart function and exercise capacity at 6 months following treatment of C-Cure, an innovative and proprietary stem cell therapy based on the Company's "Cardiopoiesis" technology.

The Cardiopoiesis platform is based on fundamental research conducted at Mayo Clinic and is designed to drive the differentiation of adult bone marrow-derived stem cells into cardiac progenitor cells which have the potential to promote heart regeneration when re-injected into the heart of patients suffering from ischemic heart failure.

Study summary

- 45 patients with heart failure secondary to ischemic heart disease were recruited in Belgium and Serbia, and randomized to optimal medical care or optimal medical care plus C-Cure treatment. Demographic and clinical baseline data were similar between 24 controls and 21 patients treated with C-Cure.

- The study showed that delivery of C-Cure is feasible without peri-procedural complications. No evidence of cell-induced systemic toxicity or pro-arrhythmogenicity was observed.

- Cardiac structural and functional parameters, assessed by echocardiography at six months versus baseline showed the benefit of C-Cure treatment.

    
       - On average, left ventricular ejection fraction (LVEF) was
         significantly augmented over baseline in the C-Cure versus control 
         cohort (5.2 plus or minus 0.6% versus 1 plus or minus 0.7%, p<0.01), 
         translating into a 18.1 plus or minus 2.3% relative increase in 
         systolic function afforded by cell therapy.

       - Reduction of end-systolic volume was 3-times larger in the
         C-Cure group compared to the control group (from 171 plus or minus 9 
         to 150 plus or minus 9mL, and from 167 plus or minus 8 to 159 plus 
         or minus 8mL, p=0.01, respectively).

       - In contrast to the control cohort, which displayed inter-individual 
         variance, C-Cure treatment invariably led to a pattern of improved 
         left ventricular function in all individuals at 6 months follow-up.

- The beneficial effects on cardiac structure and function in the C-Cure group translated into meaningful improved fitness. The 6-min walk test, an index of overall performance, increased from 396 plus or minus 26 at baseline to 449 plus or minus 35 m at six months in C-Cure (+52 plus or minus 19 m) patients while it decreased from 412 plus or minus 19 to 391 plus or minus 25 m (-21 plus or minus 14 m) in the control group between the same time points (p<0.01). To summarize, at 6 months post-therapy, C-Cure treated heart failure patients walked 73 meters more than patients that received optimal standard of care.

Dr. Jozef Bartunek explained: "Data presented today strongly suggest that C-Cure is a promising treatment for heart failure, one of the world's greatest unmet medical needs. A person living to the age of 40 has a one-in-five risk of developing heart failure and, once the disorder is apparent, a one-in-three chances of dying within a year of diagnosis. With the C-Cure trial, we show improved left ventricular and clinical performance consistent with a generalized therapeutic benefit. Moreover, we proved feasibility and safety of the C-Cure treatment regimen. The overall signs of efficacy in C-Cure treated patients are indeed encouraging and open a new chapter in cardiovascular regenerative medicine."

Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: "Heart failure affects 117 million people and cannot be cured today as current therapies only reduce the severity of disease symptoms. Regenerative therapies, such as C-Cure, may offer new hope to patients who currently have limited choices and potentially avoid the need for heart transplantation. The positive outcome of this study reiterates our belief that C-Cure can make a real difference to patients suffering from heart failure. Indeed, we are currently planning the next stages of C-Cure development and are committed to taking the steps needed to successfully bring this new and important treatment to patients. With C-Cure, we aim to become the first company with an approved regenerative product for ischemic heart failure."

About Cardio3 BioSciences

Cardio3 BioSciences is a leading Belgian biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiovascular disease.

The Company's lead product candidate, C3BS-CQR-1 (C-Cure), is a highly innovative stem cell approach for the treatment of heart failure, one of the world's most pressing unmet medical needs. Based on a comprehensive strategy developed by Cardio3 BioSciences and leveraging technology licensed from Mayo Clinic, the C-Cure development programme is designed to direct the patient's own stem cells into new heart cells with the potential to rebuild the heart.

The Cardio3 BioSciences team has extensive experience in developing and commercialising new pharmaceutical products and medical technologies and the Company's current strategy is to drive the clinical development of C-Cure and to market the product itself, if marketing authorisation is obtained, on a wide geographical scale.

Cardio3 BioSciences was founded in July 2007 and is based in Mont-Saint-Guibert (near Louvain-la-Neuve) in the Walloon region of Belgium.

Disclosures

In accordance with the Bayh-Dole Act, Mayo Clinic has licensed the technology underlying C-Cure to Cardio3 BioSciences and received an equity position in the company in the context of the license. Mayo Clinic, and the inventors of the technology, Drs. Andre Terzic and Atta Behfar, have a financial interest associated with the technology related to this research. While no royalties have accrued to date, Mayo Clinic has rights to receive future royalties which will be shared with Drs. Terzic and Behfar in accordance with the Mayo Clinic Royalty sharing policy.

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company's directors' current expectations and projections about future events. By their nature, forward-looking statements involve a number of 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. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its or their parent or subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. No undue reliance should be placed on forward-looking statements, which speak only as of the date of this press release.

    
    For more information contact:

    Cardio3 BioSciences
    Dr. Christian Homsy, CEO                  Tel: +32-10-39-41-00
    Anne Portzenheim, Communication Manager   Tel : +32-10-39-41-00
                                              aportzenheim@c3bs.com
                                              http://www.c3bs.com

    Citigate Dewe Rogerson
    Chris Gardner/Nina Enegren              Tel : +44(0)207-638-9571
                                            chris.gardner@citigatedr.co.uk
    Hill & Knowlton                         Tel : +32-2-737-95-00
    Katia Delvaille                         kdelvail@hillandknowlton.com