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news.Celladon Corporation has launched two new clinical development initiatives for MYDICAR(R), its lead product candidate, in patients with end-stage renal disease (ESRD) undergoing surgery for arteriovenous fistula (AVF) creation in preparation for hemodialysis, and in advanced heart failure patients with systolic dysfunction that were previously excluded from MYDICAR trials due to pre-existing levels of neutralizing antibodies.
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"We believe these new development initiatives will further increase the value of Celladon’s pipeline and potentially allow us to broaden the clinical utility of MYDICAR for a wide range of patients," said Krisztina Zsebo, Ph.D., Chief Executive Officer of Celladon. "Early data underlying these initiatives have shown promising results and we look forward to understanding MYDICAR’s potential in both additional settings."
Celladon plans to initiate a 100 patient Phase 2a trial with MYDICAR in ESRD patients undergoing surgery for AVF creation in preparation for hemodialysis. The trial will evaluate MYDICAR’s effect on preventing neointimal hyperplasia and improving blood flow in treated vessels, as a means to enhance the AVF maturation process.
AVF maturation failure is a common problem in approximately half of the patients that undergo the procedure. There are currently no U.S. Food and Drug Administration (FDA) approved products to enhance AVF maturation. Initial results from this study are expected in 2015.
The Company also plans to initiate a pilot, 24 patient, Phase 1/2 study of MYDICAR in advanced heart failure patients with systolic dysfunction that have been previously excluded from MYDICAR studies in this indication due to pre-existing levels of neutralizing antibodies against the AAV1 vector, which can block MYDICAR’s activity.
This study will examine whether plasma exchange can remove AAV1 neutralizing antibodies from the circulation in advance of MYDICAR administration. Based on Celladon’s database of blood samples to date, the Company estimates that approximately 60 percent of all patients in the United States currently have AAV1 neutralizing antibodies. The Company expects to initiate this study in 2014, and initial results are expected in 2015.
In addition to these clinical trials, Celladon recently completed enrollment of the 250 patient Phase 2b CUPID2 trial evaluating the efficacy of MYDICAR in reducing the frequency of, or delaying heart failure-related hospitalizations.
This randomized, double-blind, placebo-controlled, multinational trial is evaluating a single intracoronary infusion of MYDICAR versus placebo added to a maximal, optimized heart failure regimen in patients with New York Heart Association class III or IV symptoms of chronic heart failure due to systolic dysfunction.
The Company has received "breakthrough designation" from the FDA for this MYDICAR program and expects to report results from this trial in April 2015.