Mont-Saint-Guibert, Belgium, July 9, 2013 - Cardio3 BioSciences notes the publication of a blog on the Forbes.com website dated 7th July 2013 and concerning the Company's C-Cure trial published in the Journal of the American College of Cardiology (JACC) (Bartunek et al. 2013 - see below).
The presentation of the data in the C-Cure paper (JACC) (Bartunek et al. 2013 - see below) underwent stringent peer review per the American College of Cardiology publication policy. As part of the IPO process, the data and our interpretation of it have also undergone extensive due diligence.
The blog contains a number of misinterpretations or misunderstandings.
• The points raised on patients randomized are explained in the section entitled Randomization on p2330. Forty-eight patients were randomized, one patient subsequently refused participation and two were excluded on clinical criteria prior to bone marrow harvest. The figures in Table 1 and Figure 1 are consistent with the protocol and design of the study and reflect per protocol and intent-to-treat populations. Explanatory information is provided in the supplementary figures and tables available in the online version of the article.
• The primary end point of the study was safety and feasibility. References to the EU Clinical Trials Register are to a planned two-stage Phase II/III that was not executed. The data reported in JACC represent the first stage of that trial of which the primary endpoints were safety and feasibility as stated before. The ejection fraction is reported as the first efficacy signals consistent with a relatively small 45 patient trial. Those results need of course to be confirmed in a larger setting (the ongoing CHART-1 trial).
• With respect to the position of Professor William Wijns, Professor Wijns purchased, he did not receive, a number of shares in Cardio3 BioSciences in a pre-IPO financing round of 19 million EURO. This investment was made in a personal capacity and after the JACC paper had been submitted, reviewed and published. The disclosures made in this respect in the JACC publication are thus appropriate given the timing of Professor Wijns share purchase.
Cardio3 BioSciences is proud of its commitment to high quality science and its collaborations with world-renowned medical research centres. It is fully confident in the data presented in the JACC publication.
Bartunek, J., A. Behfar, D. Dolatabadi, M. Vanderheyden, M. Ostojic, J. Dens, B. E. Nakadi, M. Banovic, B. Beleslin, M. Vrolix, V. Legrand, C. Vrints, J. L. Vanoverschelde, R. Crespo-Diaz, C. Homsy, M. Tendera, S. Waldman, W. Wijns and A. Terzic (2013). "Cardiopoietic stem cell therapy in heart failure The C-CURE multicenter randomized trial with lineage-specified biologics." J Am Coll Cardiol.
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