SEATTLE, Wash., May 23, 2011 /PRNewswire/ — Celladon Corp., a
biopharmaceutical company focused on the discovery and development
of innovative treatments for cardiovascular diseases, today
announced that 18-month data from its Phase 2 CUPID clinical trial
of MYDICAR® demonstrated continued improvements in clinical
outcomes in advanced heart failure patients treated with the
genetically-targeted enzyme replacement therapy.
“We are pleased to present data from the long-term follow-up
portion of the CUPID trial with MYDICAR demonstrating reduced
hospitalizations and other cardiovascular events at 18 months after
treatment,” said Krisztina Zsebo, Ph.D., CEO and President of
Celladon, who presented the study’s long-term follow-up results
during the American Society of Cell and Gene Therapy 2011.
The study of 39 patients met its primary safety and efficacy
endpoints at 6 months for high dose MYDICAR versus placebo.
Additionally, after 12 months of receiving a single infusion
of MYDICAR, patients treated with the highest dose versus placebo
had an 88 percent risk reduction (Hazard Ratio = 0.12,
P=0.003), of major cardiovascular events such as:
- Need for left ventricular assist device (LVAD) or cardiac
- Episodes of worsening of heart failure
Additionally, the 18-month CUPID data from long-term follow-up
demonstrate a durable benefit in preventing major cardiovascular
The 12 month data presented in 2010 showed that heart failure,
which is a progressive disease, became stabilized in high dose
MYDICAR-treated patients: heart failure symptoms, exercise
tolerance, serum biomarkers and cardiac function essentially
improved or remained stable while these parameters deteriorated
substantially in patients treated with placebo and concurrent
optimal drug and device therapy.
We believe the efficacy sustained in patients over a