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Celladon Corporation Announces MYDICAR® Enzyme Replacement Therapy for Advanced Heart Failure Provides Sustained Reduction in Clinical Events in Patients for 18 Months Compar...

Mon, 05/23/2011 - 6:32am
Bio-Medicine.Org

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:

  • Death
  • Need for left ventricular assist device (LVAD) or cardiac transplant
  • 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 events.

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 18-mon

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