• A statistically-significant difference on the primary endpoint was not reached; however, a positive trend was seen across all treatment groups, and the primary endpoint was met (p=0.015) for a subset representing 60% of the population of the CHART-1 study (baseline End Diastolic Volume (EDV) segmentation).
• Based on the positive subgroup analysis, Celyad will contact the European Medicines Agency concerning a marketing authorization application.
• Prof. Jozef Bartunek will present the full 39 weeks’ data at the “Hot Line Heart Failure and Innovative Approaches” Late Breaking Clinical Trial Session at ESC on Sunday, August 28, 2016.
• Celyad will seek a partner to accelerate further development and commercialization of C-Cure®.
Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular diseases and immuno-oncology, today announced headline results for CHART-1, its European Phase III clinical trial for its lead cardiovascular disease product candidate.
Across the complete trial population, a positive trend was clearly identifiable. However, a statistically-significant difference between treatment and control (sham procedure) was not reached.
For patients representing 60% of the overall study population and categorized by their End Diastolic Volume (EDV) at inclusion, significance was met for the primary endpoint (p = 0.015). Most importantly, in this subgroup, a strong trend or a statistical significant positive difference was seen in all individual elements of the composite primary endpoint (Mortality, Worsening Heart Failure Events, Quality of Life, 6 minutes Walking Test, End Systolic Volume and Ejection Fraction).
The study procedure was well tolerated with no safety concerns.
The CHART-1 trial has been selected by the European Society of Cardiology to be presented at the “Hot Line Heart Failure and Innovative Approaches” Late Breaking Clinical Trial session of the ESC congress in Rome on Sunday, August 28, 2016, at 11:54 am CEST. The European Society of Cardiology has organized a press conference scheduled at 8 am CEST on the same day.
Based on the positive results seen in this highly clinically relevant group of patients for whom treatment options are currently limited, Celyad will contact the European Medicine Agency concerning a marketing authorization application.
The Company will use the CHART-1 results as a foundation to optimize the design of the pivotal CHART-2 US trial. In line with this, Celyad confirms it is seeking partnerships to accelerate further development and commercialization of C-Cure®.
At the Company’s request, trading in Celyad stock (CYAD.BR) will be suspended on June 28, 2016, until the completion of the conference call scheduled at 2:00pm CEST (see details below).
Dr. Christian Homsy, CEO of Celyad, commented: “For the first time in a randomized, double-blind, controlled, Phase III cell therapy study, a positive effect, consistent across all parameters tested, was observed for a substantial, clearly definable, group of heart failure patients.
CHART-1 has allowed us to better define the patient population that would benefit from
C-Cure®. We are excited by the prospects for C-Cure® as a new potential treatment option for a highly relevant heart failure population. We are confident that the results will generate interest from potential partners that could accelerate the development and commercialization of
C-Cure®.”
Prof. Jozef Bartunek, CHART-1 principal co-investigator, said: “This pioneering study has contributed greatly to our understanding of heart failure disease and the place of regenerative medicine in its management. The results seen for a large clinically relevant number of the patients are ground breaking. We look forward to completing the full analysis and making the data available to the medical community at ESC.
On behalf of the CHART 1 steering committee we wish to thank the patients and families who were enrolled in the study as well as all the physicians and medical teams that made this study possible.”
Prof. Gerasimos Filippatos, Immediate Past-President of the Heart Failure Association of the European Society of Cardiology, member of the CHART-1 dissemination committee, said, “The CHART-1 results have identified a well-defined group of patients with symptomatic heart failure despite optimal therapy. Those patients are a large subset of the heart failure population and present specific therapeutic challenges. The outcome of CHART-1 indicate those patients could benefit from this therapy”.
Conference Call Details
A conference all will be held on Tuesday, June 28, 2016 at 2:00pm (CEST) / 8:00am (EDT) to review the topline results of the CHART 1 study. Christian Homsy, Chief Executive Officer, will deliver a brief presentation followed by a Q+A session.
Participants are asked to call the assigned numbers approximately five minutes before the conference call begins.
The call can be accessed by dialing the numbers below and using the conference ID: 41106485
International: +44 (0) 1452 560304
Belgium: 024017052
France: 0800918149
UK: 08000738965
US: 18669265708
