Celyad announces the “C-Cure Cell Therapy – CHART -1, “Clinical Trial Phase III

Celyad announces the “C-Cure Cell Therapy – CHART -1, “Clinical Trial Phase III

  • Research showed a positive trend for improvement and in the experimental study of CHART-1 (baseline end-diastolic volume (EDV) segment), the population was representative of the overall effect of the study. Representing the total 60% of the small population showed the primary end point (p=0.015)
  • Based on the positive results obtained for the small group analysis, Celyad will submit to the European Medicines Authority for applying a listing license.
  • Prof. Jozef Bartunek will present a paper on “Heart Failure and Innovative Technology on August 28, 2016 on the European Society of Cardiology (ESC). He will announce the complete data and findings obtained from the 39 weeks of Testing.
  • Celyad will seek partners to accelerate the further development and commercialization of C-CURE®.

Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ : CYAD) is a leading company in research and development of engineering cell therapy industry. Its main focus is in the research of clinical programs for cardiovascular disease and tumor immunity. Today is to announce the research result of the C-CURE Cell Therapy – CHART – 1, the clinical research Phase III.

In all patient groups, positive trend in the treatment group were significantly observed. However, the difference between the treatment group and the control group (Virtual surgery) did not reach statistical significance.

For the 60% of the patient population representing the entire study group, the End- diastolic volume (EDV) was classified in the selected patient. The end result of the study was statistically significant (P = 0.015). Most importantly, in this small grouping, a strong positive trend or a statistically significant difference occurs in every element of the study’s major elements (mortality, heart failure, quality of life, six minutes’ Treadmill, End=diastolic Volume and blood ejection volume)

The research process showed good tolerance, with no safety hazards.

The CHART-1 trial study has been endorsed by the European Society of Cardiology to be presented on the Heart Failure and Innovative technology section at the meeting of the Research Committee meeting which will be held in Rome on August 28, 2016, at 11:45am European Society Cardiology’s press conference will also be held at 8:00 am at Central and Western time.

Based on the positive results obtained for the small group analysis, Celyad will submit to the European Medicines Authority for applying a listing license.

Based on the result of CHART-1, with further improvement on the design of the research, the company will process on the CHART-2. Celyad will accelerate the further development and commercialization of C-CURE®.

Upon the request of the company, the stock transaction of Celyad (CYAD.BR) will be suspended on 28 June 2016 until the end of the conference call at 2:00pm Central European Time.


CEO of Celyad, Dr. Christian Homsy said, “ This is the first time in a randomized, double-blind, controlled, three-stage cell therapy study, where all test parameters consistently show a group of patients who are clearly defined as heart failure, do show a positive treatment effect.

The result of CHART-1 allows us to better identify the population of patients who will benefit from C-CURE®. We are very excited about the prospect of C-CURE® providing a new potential treatment option for highly relevant heart failure populations. We believe that these results will lead to potential partners and many accelerate the development and commercialization of C-CURE®.


The Principal Investigator of CHART-1, Prof. Jozef Bartunek said, “This pioneering research has made a significant contribution to our understanding of heart diseases and the recognition of the role of regenerative medicine in the management of heart diseases. The results of the clinically relevant patients are brand-new and we look forward to completing the complete analysis and publishing our data in the ESC
medical community.”

“On behalf of the CHART-1 Steering Committee, I would like to thank all the patients

and their families who have been included in the study and all the doctors and medical team members who have made this study possible.”

 

Former Chairman of the European Society of Cardiology, Committee member of CHART-1, Prof. Gerasimos Filippatos said,
“The result of CHART-1, although is not specifically defined for the best treatment, but outline a group of patient with obvious symptoms of heart failure. A consideration proportion of the population of heart failure patients can have a specific new treatment challenge. CHART-1 results show that most of these patients can benefit from this treatment.