Celyad account to use this label to expedite and facilitate the search for a strategic partner for C-Cure
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This label has been obtained on the basis of the promising results obtained at 9 months on the subset of patients that responded favorably to treatment, C-Cure, confirmed since by the results at 12 months
Mont-Saint-Guibert, Belgium Celyad (Euronext Brussels and Paris, and NASDAQ : CYAD), a leader in the discovery and development of cell-based therapies specialist, today announced that the u.s. Food and Drug Administration (FDA) has granted him the label Fast Track for his or her therapy C-
Cure®.
The FDA has granted this label Fast Track whereas in CHART-1, the reduction of the mortality, number of hospitalizations, and improving the quality of life of patients with chronic heart failure due to ischemic cardiomyopathy, with an end-diastolic volume of the left ventricle (Left Ventricular End Diastolic Volume LVEDV) between 200 and 370 ml.
The therapy C-Cure® Celyad is a cell-based therapy among the most advanced for the treatment of congestive heart failure. The results of the trial CHART-1 have helped to identify a significant proportion of patients who responded favorablemeent treatment, C-Cure® and the optimal dosing better defined. This has recently been confirmed by the data of 12 months recently presented by the Teacher. John Teerlink during a “Late Breaking Session” given at the conference of the European Society of Insufisance heart (Paris, may 1, 2017), which will be the subject of a future publication in the scientific journal ” European Journal of Heart Failure “.
In December 2015, Celyad has obtained approval from the FDA to CHART-2, a pivotal phase III study for C-Cure® prospective, multicenter, randomized and controlled. Celyad is currently seeking one or more strategic partners to launch the clinical trial CHART-2.
Dr Christian Homsy, CEO of Celyad said : “Although all our resources are currently focused on the development of our platform in immuno-oncology, received the label Fast Track for C-Cure® highlights the quality of the science and the strength of the results at 9 and 12 months generated when testing CHART-1. With the support of the business bank Piper Jaffray & Co., we hope to be able to identify a partner to continue the development of this program.”
The Development Program Fast Track FDA approval (“Fast Track Drug Development Program “) is intended to facilitate the clinical development and regulatory of severe pathologies, and fill unmet medical needs. More specifically, the label Fast Track allows for frequent interactions with the teams from the FDA, including support to prepare product approval. It also allows you to submit sections of a recording folder as the clinical data become available.
For more information about Fast Track, visit the website of the FDA (http://www.fda.gov).
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About Celyad
Celyad is a company’s clinical-stage biopharmaceutical in the development of cellular therapies. The Company uses its expertise in cellular development to target the cancer. The platform NKR-T Celyad is based on T-Cell changes in order to push them to express a Receptor of Natural Killer Cells (NK). This technology offers a potential therapeutic very wide, both in solid tumors than in the blood. BECAUSE-T NKR-2 is the product most advanced candidate of Celyad in oncology. This therapy has been the subject of a first clinical study of Phase I study to evaluate the safety of the product in patients with two types of blood cancer, Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM), This study was successfully completed in September 2016. Celyad was founded in 2007. The Company is based in Mont-Saint-Guibert, Belgium, and Boston, in the United States. The actions of Celyad are listed on Euronext Brussels and Euronext Paris under the symbol CYAD. The ADSS are quoted on the NASDAQ Global Select Market under the symbol ” CYAD “.
For more information on Celyad, go on www.celyad.com
About C-Cure®
C-Cure® is the project of Celyad the more advanced, in development, in clinical indications related to congestive heart failure original ischemic insult. The research at the basis of this technology was conducted at the Mayo Clinic by the research team of professors Andre Terzic and Atta Behfar. She has been published in numerous scientific journals of high level. C-Cure® consists of cells from the bone marrow of the patient, reprogrammed into reparative cells of the heart (cardiopoïétiques) with the addition of growth factors, and then reinjected into the heart. It is designed to enhance the capacity of restorative of the heart.
About CHART-1
The study is CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) is a Phase III clinical study that evaluates cell therapy for the treatment of heart failure original ischemic insult. CHART-1 is a prospective, multicenter, randomized, controlled, double-blind (patients and evaluators), comparing the treatment of C-Cure® to a control procedure. The study focused on 271 patients with chronic symptomatic heart failure advanced in 12 countries, located in Europe and Israel. The study is designed to evaluate the safety and efficacy of C-Cure®. The primary endpoint in this study is a score combining mortality, morbidity, quality of life, walking distance in six minutes, the structure and function of the left ventricle. This criterion will be evaluated at nine months after treatment.
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