Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, today announced the initiation of the certification procedure by the European Medicines Agency (EMA) of the non-clinical data of its lead product, C-Cure®, currently in the follow-up period of its CHART-1 Phase III clinical trial in Europe and Israel.
The certification procedure involves the scientific evaluation by the European Medicines Agency’s Committee for Advanced Therapies (CAT) of non-clinical data generated for
C-Cure®. It aims to prepare the submission of a marketing-authorization application.
Dr Christian Homsy, CEO of Celyad, commented: “This is another great step in the preparation of the marketing authorization dossier of our lead product C-Cure®. In April 2014, we obtained the certification of the quality part of the dossier. If granted in spring next year, this other certification should enable us to file for marketing authorization only a few months after the readout of the CHART-1 data, expected mid 2016”.
C-Cure® is Celyad’s most advanced product candidate based on its cardiopoiesis platform and is being developed for heart failure indications. The Company expects to release the full clinical data set for CHART-1, its Phase III trial in Europe and Israel, in the middle of 2016. The research underlying this technology was originally conducted at Mayo Clinic by the research team of Professor André Terzic and Atta Behfar, and has been published in numerous peer-reviewed publications. C-Cure® consists of a patient’s own cells harvested from bone marrow, treated with cardiopoietic growth factors and then re-injected into the heart. It is designed to produce new autologous heart muscle cells which behave identically to those lost as a result of infarction, without the risk of rejection.
C-Cure®’s potential has been demonstrated in a multi-centre randomized controlled Phase II trial conducted in Europe. The results of the C-Cure® Phase II trial were published in April 2013 in the Journal of American College of Cardiology.
ATMPs and European Regulation on ATMPs
The European Regulation (EC) No 1394/2007 provides a consolidated framework for this innovative class of products, including a procedure allowing SMEs to voluntarily apply for the certification of the pharmaceutical quality and the pre-clinical data of an ATMP (Advanced Therapy Medicinal Product). The aim is to offer an early dialogue with the Agency, to clarify regulatory requirements and provide feedback on the quality and completeness of data submitted.
While the certification procedure is independent from a Marketing Authorization Application (MAA), it follows the scientific and technical requirements necessary to facilitate the preparation, filing and evaluation of a future MAA. The issuance of a certificate by the EMA, expected in spring 2016, will confirm that the data submitted for an ATMP meet the scientific and technical standards that apply to other pharmaceutical and biotechnology products.