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Sunshine Heart Inc. Message Board

  • bigsmartsta bigsmartsta May 25, 2014 9:37 PM Flag

    MYDICAR vs C-PULSE

    SAN DIEGO, March 31, 2014 (GLOBE NEWSWIRE) -- Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced financial results for the quarter and year ended December 31, 2013.

    "Celladon executed on key operational and financial objectives in 2013. With the recent completion of enrollment of our CUPID 2 trial of MYDICAR in advanced heart failure and the closing of our IPO, we are setting the stage for another productive year ahead," said Krisztina Zsebo Ph.D., President and Chief Executive Officer.

    2013 and Recent Corporate Highlights

    MYDICAR

    -- In February 2014 we completed enrollment in the Phase 2b study with lead product candidate MYDICAR. This trial, "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease" (the "CUPID 2 Trial") is a multinational, multicenter, double-blind, placebo-controlled, randomized study comparing a single intracoronary administration of MYDICAR versus placebo added to an optimal heart failure regimen. The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or dilated cardiomyopathy and NYHA class III/IV symptoms of heart failure by reducing the frequency and/or delaying heart failure-related hospitalizations compared to placebo-treated patients. Secondary objectives include assessment of the safety of MYDICAR by determining the incidence and severity of adverse events and changes in laboratory parameters. A total of 250 patients were enrolled and data from this trial is expected in April 2015.

    -- In November 2013, the European Medicines Agency (EMA) indicated that if MYDICAR demonstrates a substantial and highly significant treatment effect in the advanced heart failure population, and no untoward effects attributable to MYDICAR are observed, a safety database of approximately 205-230 MYDICAR

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    • SAN DIEGO, April 10, 2014 (GLOBE NEWSWIRE) -- Celladon Corporation (CLDN), a clinical-stage biotechnology company developing novel therapies for patients with heart failure and other diseases characterized by SERCA enzyme deficiencies, today announced that its lead product candidate, MYDICAR(R), has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (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 and where preliminary clinical evidence suggests it provides a substantial improvement over existing therapies. Celladon is developing MYDICAR as a novel, first-in-class therapy for patients with chronic heart failure due to systolic dysfunction. MYDICAR uses genetic enzyme replacement therapy to correct the deficiency in the enzyme SERCA2a, which is an enzyme that becomes deficient in heart failure patients and results in inadequate pumping of the heart. Celladon has developed a companion diagnostic to identify the patients who are AAV1 NAb negative and therefore eligible for MYDICAR treatment.

 
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