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 disease and immuno-oncology, today announced that the EMA has issued a certification for C-Cure®non-clinical data.
C-Cure® (C3BS-CQR-1) is a cardiovascular lineage-committed cell therapy product being developed for the treatment of ischemic heart failure, currently in a pivotal phase III clinical trial in Europe and Israel. The EMA certification announced today is the second of three modules, following the certification of quality data obtained in May 2014, made in preparation for a marketing application. The certification provides confirmation that the Committee for Advanced Therapies (CAT), recognizes that the C-Cure® development program continues to meet the rigorous standards set by the EMA for a successful development and submission package.
Dr. Jean-Pierre Latere, Head of Cardiovascular Franchise at Celyad, commented: “This certification acknowledges the rigor of our work and we continue to execute on our plans to make C-Cure® available to patients with ischemic heart failure. We are optimistically awaiting the CHART 1 Phase III results which are expected end of June 2016.”
Dr. Richard Mountfield, Head of Regulatory Affairs and Clinical Operations at Celyad, commented: “Through constructive collaboration with CAT, the issuing of this certification for the non-clinical data for C-Cure® further reflects the positive Regulatory environment for our Marketing Authorization Application.”
European Regulation on ATMPs
ATMPs (Advanced Therapy Medicinal Product) are at the forefront of biotechnology and medical innovation. Because of their novelty and complexity, evaluating the quality, safety, and efficacy of ATMPs often requires the development of alternative approaches that go beyond what is needed for conventional medicines.
The European Regulation (EC) No 1394/2007 provides a consolidated framework for this innovative class of products, including a procedure allowing SMEs (Small to Medium Enterprises) to voluntarily apply for the certification of the pharmaceutical quality and the pre-clinical data of an ATMP. The aim is to offer an early dialogue with the EMA, to clarify regulatory requirements and provide feedback on the quality and completeness of data submitted.