Celladon Corporation, a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, and SIRO Clinpharm, will present analysis methods for the MYDICAR development programme at an upcoming conference. ‘Statisticians in the Pharmaceutical Industry International Conference’ will be held in Glasgow, UK, from May 12-15, 2013.
“This conference presentation represents additional recognition of Celladon’s innovative approach to the MYDICAR development programme, and has many benefits over traditional analysis methods including reduced sample size relative to other heart failure trials. It is the first time the US Food and Drug Administration has accepted the use of this statistical analysis method as part of a primary endpoint in a clinical trial for the treatment of heart failure,” said Krisztina Zsebo, President and Chief Executive Officer, Celladon Corporation.
MYDICAR is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling in the heart and cardiac contractility. SERCA2a levels decline in all forms of late-stage HF resulting in deficient heart function. With MYDICAR, the SERCA2a gene is delivered using recombinant adeno-associated virus (AAV) as the vector. AAV is a naturally occurring virus not associated with any disease in humans. MYDICAR is delivered in a single dose directly to the heart during a routine outpatient cardiac catheterization procedure, similar to an angiogram. MYDICAR is synergistic and additive across current HF treatments such as ACE inhibitors, beta-blockers, sprinolactone/diuretics, and biventricular pacing devices.
EP News Bureau – Mumbai