11:46 am Vericel presents results from its Phase 2b ixCELL-DCM clinical study of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (shares halted) (VCEL) :
The trial met its primary endpoint with patients in the ixmyelocel-T group having a 37 percent reduction in all-cause deaths, cardiovascular hospitalizations, or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months following treatment compared to the placebo group (p=0.0344). The primary endpoint was driven by a reduction in both all-cause deaths and cardiovascular hospitalizations. In the primary endpoint without procedure-related events, three percent of patients in the ixmyelocel-T group died and 38 percent had cardiovascular hospitalizations one or more times, compared to 14 percent and 47 percent, respectively, in the placebo group. All deaths were adjudicated to be due to cardiovascular causes.
•With respect to the secondary endpoints of the trial, the components of the primary endpoint were also analyzed using the Win ratio in a hierarchical manner to incorporate both the incidence and timing of the endpoint components. The Win ratio result of 1.56 showed that more often ixmyelocel-T was the "winner" in that the time to death, left ventricular assist device placement, heart transplantation or time to cardiovascular hospitalization was shorter for placebo-treated patients, but this difference did not reach statistical significance. The time to first event was longer in the ixmyelocel-T group compared to placebo, but was not statistically significant. There were no significant structural changes in left ventricle cavity size or left ventricular ejection fraction as measured by echocardiogram in either the ixmyelocel-T or placebo groups. Both treatment groups had an improvement in the NYHA class and six minute walk test, with no statistical difference between the groups at month 12 using last observation carried forward.
•Overall, there were fewer adverse events and serious adverse events in the ixmyelocel-T group compared to the placebo group. Adverse events included those typically related to catheterization or injection procedures.
•The ixCELL-DCM trial showed a statistically significant reduction in clinical events driven by both cardiac mortality and cardiac hospitalizations at 12 months compared to placebo. These results are consistent with two previous Phase 2a studies which showed that ischemic DCM patients treated with ixmyelocel-T experienced fewer major adverse cardiovascular events during follow up compared to control patients.
