The current study,The Phase 2b study titled “Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease” (“CUPID Phase 2b Trial”) is a multinational, multicenter, double-blind, placebo-controlled, randomized study currently recruiting subjects in the United States and in Europe. Results are anticipated in the first half of 2015. Please visit the ClincalTrials.gov website for more information, or call Celladon Corporation 1-858-366-4288.
The phase 2 CUPID Trial successfully met its primary safety and efficacy endpoints at 6 months for high dose MYDICAR® versus placebo. Additionally, 12 months after receiving a single infusion of MYDICAR®, patients treated with the highest dose versus placebo had an 88 percent reduction of major cardiovascular events* such as death, need for left ventricular assist device (LVAD) or cardiac transplant, and number of heart failure-related hospitalizations.
Celladon scientists, led by company co-founder Roger J. Hajjar, M.D., Director of the Cardiovascular Research Center at Mount Sinai School of Medicine, New York, developed MYDICAR®, a potential breakthrough for the treatment of severe heart failure. MYDICAR is designed to restore a critical enzyme necessary for the heart to pump more efficiently. Read More
Celladon Corporation Completes Second Close of Recent Venture Financing
-MPM Capital and LSP Life Sciences Partners join existing Celladon investment syndicate-
- Total capital proceeds of recent investment round increased to $53 million-
San Diego, California, May 7, 2012/PRNewswire/ -- Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced the receipt of additional capital proceeds from a second close of its recent venture financing to advance the Company’s lead investigational product candidate MYDICAR® for the treatment of advanced heart failure. This financing was executed as an extension of its recent venture financing, which closed on February, 2012 and included new investors MPM Capital and LSP Life Sciences Partners. With this second close, total capital proceeds from the recent investment round is now $53 million. MPM Capital and LSP Life Sciences Partners join existing Celladon investors Pfizer Venture Investors, Lundbeckfond Ventures, Novartis Venture Funds, Hambrecht and Quist Capital Management, GBS Venture Partners, Enterprise Partners Venture Capital, Johnson & Johnson Development Corp., and Venrock.
In conjunction with this financing, Celladon has added Todd Foley, Managing Director at MPM Capital, and Fouad Azzam Ph.D., General Partner at LSP Life Sciences Partners, to its Board of Directors. Celladon will also establish a subsidiary in The Netherlands to manage its European based activities.
“This capital infusion further strengthens Celladon’s cash position and activities in Europe, and we welcome MPM Capital and LSP Life Sciences Partners to our top-tier investment syndicate. Together, we will progress the continued development of MYDICAR for patients with advanced Heart Failure.” said Krisztina Zsebo Ph.D., President and CEO of Celladon Corp.
About the CUPID Trial
The previously announced results of the phase 2 CUPID Trial met its primary safety and efficacy endpoints at 6 months for high dose MYDICAR® versus placebo. Additionally, 12 months after receiving a single infusion of MYDICAR®, patients treated with the highest dose versus placebo had an 88 percent risk reduction (Hazard Ratio = 0.12, P=0.003) of major cardiovascular events such as death, need for left ventricular assist device (LVAD) or cardiac transplant, episodes of worsening heart failure and 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 years of age 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.
The safety profile from this study was very favorable, with no significant side-effects from MYDICAR® therapy.
MYDICAR® is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling and contractility. SERCA2a levels decline in all forms of late-stage heart failure resulting in deficient heart function. With MYDICAR®, the SERCA2a gene is delivered using a recombinant adeno-associated virus (AAV) as the vector. AAV is a naturally occurring virus not associated with any disease in humans. MYDICAR® is delivered in a single dose directly to the heart during a routine outpatient cardiac catheterization procedure, similar to an angiogram. MYDICAR® is synergistic and additive across current heart failure treatments such as ACE inhibitors, beta-blockers, sprinolactone/diuretics, and biventricular pacing devices. No treatment substitution decision is required by the treating physician.
About Heart Failure
Chronic heart failure is a leading cause of hospitalization and is expected to result in direct and indirect costs of $39.2 billion to the U.S. healthcare system in 2010. Nearly 6 million people in the U.S. have heart failure, and at least 670,000 new cases will be diagnosed this year. Heart failure leads to about 280,000 deaths annually. The most common symptoms of heart failure are shortness of breath, feeling tired and swelling in the ankles, feet, legs and sometimes the abdomen. There is no cure.
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For further information, please contact:
Kristina Zsebo, PhD, President & CEO