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April 10, 2014
08:42 EDTCLDNCelladon's Mydicar candidate granted breakthrough therapy designation by FDA
Celladon's lead product candidate, Mydicar, has been granted breakthrough therapy designation by the FDA for reducing hospitalizations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative. This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Celladon is currently evaluating Mydicar in the Phase 2b CUPID 2 trial to determine its efficacy in reducing the frequency of and/or delaying heart failure-related hospitalizations. The company expects to report results in April 2015.
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July 21, 2014
07:10 EDTCLDNCelladon announces in-license of stem cell factor development program
Celladon announced an exclusive, global license from Enterprise Partners Venture Capital for gene therapy applications of the membrane-bound form of the Stem Cell Factor gene, or mSCF, for treatment of cardiac ischemia. Stem Cell Factor is a critical cytokine which contributes to cell migration, proliferation, and survival of cardiac stem cells. Researchers at the Cardiovascular Research Center at Icahn School of Medicine at Mount Sinai have successfully tested mSCF gene therapy to reverse heart damage following myocardial infarction in animal models. Celladon plans to commence further preclinical work, building on available data from Mount Sinai in myocardial infarction.

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