Phase III CardiAMP Trial Shows Heart Failure Benefits, Especially in Elevated NTproBNP Subgroup

BioCardia, a biotechnology firm dedicated to the development of cell therapy for cardiovascular conditions, has reported encouraging interim outcomes from a Phase III trial of its CardiAMP® treatment for chronic heart failure. The study involved 110 participants and demonstrated a significant decrease in heart-related mortality and major adverse cardiac and cerebrovascular events (MACCE) after an average follow-up period of 20 months.

The CardiAMP treatment involves the use of a patient's own bone marrow cells, which are delivered to the heart via a minimally invasive catheter-based procedure. This approach aims to stimulate the body's innate healing mechanisms. The therapy stands out due to its unique combination of pre-procedural cell analysis for patient selection, a high dosage of cells, and a proprietary delivery system that has been shown to enhance cell retention and safety.

Among the trial's findings, patients with elevated NTproBNP levels, an indicator of heart distress, experienced an even more pronounced reduction in heart death equivalents, with an 86% relative risk decrease. The treatment also showed a trend towards reduced ventricular tachyarrhythmias and improved heart function, as indicated by an increase in left ventricular ejection fraction.

Dr. Amish Raval, a key investigator in the study, highlighted the significance of these results, particularly for the majority of heart failure patients who exhibit elevated NTproBNP levels. Despite advancements in medication and devices, heart failure remains a significant health issue, and the potential of CardiAMP to improve survival rates and reduce hospital readmissions is a promising development.

BioCardia's CEO, Peter Altman, expressed gratitude for the FDA's swift approval of a follow-on Phase III trial, which will focus on patients with elevated NTproBNP levels. This trial, known as CardiAMP HF II, is expected to validate the interim results and secure further support for the therapy.

Additionally, BioCardia reported the first enrollment in the dose escalation safety phase of its CardiALLO™ study, an allogeneic mesenchymal stem cell therapy for heart failure patients. The initial cohort to receive the lowest dose of cells has shown no adverse events, indicating a positive start to the trial.

BioCardia is based in Sunnyvale, California, and is committed to developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. The company's platforms, CardiAMP and CardiALLO, represent its commitment to treating heart disease through innovative biotherapeutic approaches.

It is important to note that both CardiAMP and CardiALLO therapies are still considered investigational and are limited to use within the scope of ongoing research and trials. BioCardia continues to work towards advancing these therapies with the goal of improving patient outcomes in the field of cardiovascular health.