Nov 16 2010
Targeted Genetics Corporation (Pink Sheets: TGEN.PK) ("Company") announced that its partner, Celladon Corporation, today presented 12-month data from its Phase 2 CUPID clinical trial of MYDICAR® demonstrating significant improvements in clinical outcomes and key disease markers in advanced heart failure patients treated with the genetically-targeted enzyme replacement therapy.
Celladon presented the following data and results at the American Heart Association annual meeting in Chicago today:
- 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,>
- Death
- Need for left ventricular assist device (LVAD) or cardiac transplant
- Episodes of worsening of heart failure
- Number of heart failure-related hospitalizations
The mean duration of hospitalization in the MYDICAR high dose group during the 12-month period was 0.4 days per patient compared with 4.5 days per patient in the placebo group. This finding is especially noteworthy because heart failure is the leading cause of hospitalization in Americans 65 and older. Additionally, the 12-month CUPID data show 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 the same while these parameters deteriorated substantially in patients treated with placebo and concurrent optimal drug and device therapy.
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