The US FDA determined that the C-Cure®/C-Cathez™ combination safety profile obtained from the CHART-1 trial allows the initiation of the CHART-2 Heart Failure Clinical Trial in the US
MONT-SAINT-GUIBERT, Belgium I December 21, 2015 I Celyad (Euronext Brussels:CYAD) (CYAD.PA) (CYAD.PA), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application to proceed thus allowing for the clinical testing of Celyad’s lead cardiology candidate (C-Cure cardiopoietic cells) delivered via the proprietary catheter (C-Cathez) in the Phase III Heart Failure Trial (CHART-2) in the US.
CHART-2 is intended to assess the efficacy of C-Cure as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded Phase III study comparing treatment with C-Cure to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.
Dr. Christian Homsy, Chief Executive Officer of Celyad: “CHART-2 study using Celyad’s lead cardiology candidate (C-Cure cardiopoietic cells) delivered via our proprietary catheter (C-Cathez) will allow us to expand our Phase III clinical program and allow US clinical sites and patients to participate in our trials. We also expect that our fully proprietary approach will give us an innovative value added proposition when it comes to the potential commercialization of the treatment.”
Dr. Warren Sherman, Chief Medical Officer of Celyad: “Celyad’s patient centric approach is served by providing potentially the best possible combination of C-Cure with C-Cathez for the treatment of ischemic heart failure. C-Cathez best in class catheter provides more than three times higher retention of viable cells one hour after the injection than other designs, and hence potentially optimizes the effect of C-Cure.”
About Celyad
Founded in 2007, and based in Belgium, Celyad is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiology and oncology. Celyad is developing its lead cardiovascular disease product candidate, C-Cure, for the treatment of ischemic heart failure, and has completed enrollment of a Phase III trial in Europe and Israel. In addition, the Company is developing a novel portfolio of CAR T-cell therapies that utilize human Natural Killer cell receptors for the treatment of numerous blood and solid cancers. Its lead oncology product candidate, NKG2D CAR T-cell, entered a Phase I clinical trial in April 2015.
Celyad’s ordinary shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CYAD and Celyad’s American Depositary Shares are listed on the NASDAQ Global Market under the ticker symbol CYAD.
SOURCE: Celyad
Post Views: 246
The US FDA determined that the C-Cure®/C-Cathez™ combination safety profile obtained from the CHART-1 trial allows the initiation of the CHART-2 Heart Failure Clinical Trial in the US
MONT-SAINT-GUIBERT, Belgium I December 21, 2015 I Celyad (Euronext Brussels:CYAD) (CYAD.PA) (CYAD.PA), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application to proceed thus allowing for the clinical testing of Celyad’s lead cardiology candidate (C-Cure cardiopoietic cells) delivered via the proprietary catheter (C-Cathez) in the Phase III Heart Failure Trial (CHART-2) in the US.
CHART-2 is intended to assess the efficacy of C-Cure as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded Phase III study comparing treatment with C-Cure to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.
Dr. Christian Homsy, Chief Executive Officer of Celyad: “CHART-2 study using Celyad’s lead cardiology candidate (C-Cure cardiopoietic cells) delivered via our proprietary catheter (C-Cathez) will allow us to expand our Phase III clinical program and allow US clinical sites and patients to participate in our trials. We also expect that our fully proprietary approach will give us an innovative value added proposition when it comes to the potential commercialization of the treatment.”
Dr. Warren Sherman, Chief Medical Officer of Celyad: “Celyad’s patient centric approach is served by providing potentially the best possible combination of C-Cure with C-Cathez for the treatment of ischemic heart failure. C-Cathez best in class catheter provides more than three times higher retention of viable cells one hour after the injection than other designs, and hence potentially optimizes the effect of C-Cure.”
About Celyad
Founded in 2007, and based in Belgium, Celyad is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiology and oncology. Celyad is developing its lead cardiovascular disease product candidate, C-Cure, for the treatment of ischemic heart failure, and has completed enrollment of a Phase III trial in Europe and Israel. In addition, the Company is developing a novel portfolio of CAR T-cell therapies that utilize human Natural Killer cell receptors for the treatment of numerous blood and solid cancers. Its lead oncology product candidate, NKG2D CAR T-cell, entered a Phase I clinical trial in April 2015.
Celyad’s ordinary shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CYAD and Celyad’s American Depositary Shares are listed on the NASDAQ Global Market under the ticker symbol CYAD.
SOURCE: Celyad
Post Views: 246
