A non-drug immunotherapy for patients with heart failure has failed to show its efficacy in a Phase III trial reported at the World Congress of Cardiology conference in Barcelona, Spain, but could still emerge as a treatment option.
The Celacade System, developed by Canadian company Vasogen, involves taking 10mL whole blood out of a patient, stressing it to stimulate an anti-inflammatory response and then re-injecting it into the patient. The hypothesis is that this will reduce inflammatory mechanisms that contribute to the decline in function of the failing heart.
But while the results of the 2,400-patient ACCLAIM study failed to show that the approach had any benefit in reducing deaths or hospitalisation for cardiovascular reasons in patients with chronic heart failure, subgroup analyses suggested that the treatment had a statistically significant benefit in patients with in the earlier stages of the disease.
Among 689 patients with New York Heart Association (NYHA) class II patients in the study, Celacade reduced the risk of mortality or CV hospitalization by 39% (p=0.0003).
And additional exploratory analysis in combined subgroups totalling over 70% of ACCLAIM study subjects indicated that Celacade immunotherapy was significantly more beneficial than placebo in reducing risk of mortality or morbidity, according to principal investigator Guillermo Torre-Amione of Baylor College of Medicine in the USA.
“The ACCLAIM trial findings support the hypothesis that inflammation participates in the progression of [heart failure],” commented Dr Torre-Amione, who said there was now a ‘strong basis’ for moving forward with a confirmatory trial of the procedure.