| Press Release - November 17, 2009 |
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Celladon Corporation Announces Upcoming Presentations at Orlando, FL and San Diego, CA – November 17, 2009 – Celladon Corporation, developing therapies for the treatment of heart failure, today announced upcoming data presentations at the American Heart Association (AHA) Scientific Sessions, November 14-18, 2009, Orlando, Florida. Tuesday, November 17 International Congress Plenary Special Session Presentation The two presentations by Roger Hajjar, M.D., from Mt. Sinai School of Medicine will review ongoing trials in heart failure using genetic modification. He will provide an update on the follow-up of patients in the Phase 1 portion of the Calcium Up-regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) trial utilizing MYDICAR® (AAV1/SERCA2a). This is a First-in-Man open-label, sequential dose escalation, multi-center phase of the trial and was designed to investigate safety and biological effects of restoring SERCA2a enzyme activity in failing heart muscle cells. The trial enrolled patients with severe forms of ischemic and dilated cardiomyopathies who had New York Heart Association Class III or IV heart failure, significantly impaired heart pumping function, and less than half the normal ability to transport and utilize oxygen during cardiopulmonary exercise testing. The phase 1 dose-escalation data demonstrate that MYDICAR® had an acceptable safety profile in 12 patients and 4 increasing doses. Safety was determined by study investigators and an independent safety monitoring committee. In addition, improvements from baseline to 6 months were observed across a number of key efficacy parameters important in assessing heart failure status. Efficacy was defined as the mean improvement in at least 2 of 5 endpoints without any worsening in the remaining endpoints, including a functional six-minute walk test, oxygen consumption, quality of life questionnaire, biomarker activity and left ventricular size and function. Celladon has also completed Phase 2 enrollment of the CUPID trial which is a randomized, double-blind, placebo-controlled study in a similar patient population as the Phase 1 trial. This CUPID Phase 2 trial enrolled 39 Patients who were treated with 1 of 3 doses of MYDICAR® or placebo via a single intracoronary infusion and will continue to be followed for 12 months after administration. Effects of treatment will be assessed by changes in how the heart contracts, a blood test of an important marker of heart failure called NT-proBNP, symptoms of heart failure and ability to exercise. Wednesday, November 18 Poster Presentation Celladon Corporation is developing specific small molecule allosteric modulators of the SERCA2a enzyme for both acute and chronic heart failure. This CDN small molecule trial is designed to activate SERCA2a in a dose and calcium dependent manner, intravenously or orally, for the treatment of acute and chronic heart failure. The study presented was conducted in the laboratory of Fadi Akar, Ph.D, Mount Sinai School of Medicine, New York. Allosteric modulators of SERCA2a bind to the enzyme resulting in increased activity, and enhance contractility of cardiomyocytes from normal and heart failure animals. These data indicate that CDN modulate contractility in vitro, ex vivo, and in vivo without increasing the incidence of arrhythmias. About Heart Failure About Celladon Corporation |