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BioCardia Enrolling Heart Failure Patients in New Phase III Trial Testing CardiAMP Cell Therapy

NEW YORK – BioCardia on Thursday said it has started enrolling patients in the US in the confirmatory Phase III trial studying its autologous cell therapy candidate, CardiAMP, as a treatment for ischemic heart failure with reduced ejection fraction.

The Sunnyvale, California-based company said it is launching the 250-patient randomized-controlled trial based on the US Food and Drug Administration's feedback on its design.

BioCardia previously started a pivotal Phase III trial in 2016 for this cell therapy candidate but determined last year that compared to the control arm, CardiAMP was unlikely to improve patients' outcomes measured using a primary composite endpoint that tracked deaths, major adverse cardiac events, and performance in a six-minute walking test.

The newly launched trial will home in on a subset of responders identified in the earlier trial: those with elevated levels of N-terminal pro B-type natriuretic peptide (NT-proBNP), a biomarker linked with cardiac failure and stress. The latest study also features a different composite endpoint that incorporates deaths, reduction in major adverse cardiovascular events, and improvement in quality of life.

"We are looking forward to expeditious enrollment in the trial ahead working with world class clinical heart function teams with the objective of confirming the trends of enhanced survival, reduced major adverse events, and improved quality of life observed in previous studies," BioCardia CEO Peter Altman said in a statement.