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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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October 27, 2014
07:12 EDTCLDNCelladon announces publication of data from mSCF gene therapy product
Celladon announced together with researchers at the Cardiovascular Research Center at Icahn School of Medicine at Mount Sinai, the results of pre-clinical work on the membrane-bound form of the Stem Cell Factor, or mSCF, gene therapy product candidate in the September 2014 online issue of Circulation Heart Failure. The paper is entitled "Stem Cell Factor Gene Therapy Improves Cardiac Function after Myocardial Infarction in Swine". Stem cell factor, or SCF, is a ligand of the c-kit receptor, and is a critical cytokine which contributes to cell migration, proliferation, and survival. It has been shown that SCF expression naturally increases after myocardial infarction, or MI, and may be involved in cardiac repair. The aim of this study was to determine whether mSCF gene therapy improves cardiac function in a large animal model of MI-induced heart failure. The study demonstrated clear therapeutic efficacy in the animal model, where mSCF gene therapy, delivered at the ischemic border area in the heart, improved cardiac function, decreased cardiac cell death, and increased the density of blood vessels in the heart for up to three months post-treatment. These results extend the previously reported efficacy data of stem cell factor treatment in rodents to a more clinically relevant model, supporting the potential translation of this gene therapy approach to a functional cardiac regenerative therapy.

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