BioCardia has announced the primary endpoint results of the open label roll-in cohort of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia trial.
Results from the open label roll-in cohort patients having chronic myocardial ischaemia with refractory angina show that the minimally-invasive CardiAMP cell therapy procedure was well tolerated with no treatment emergent major adverse cardiac events, the company states in a press release.
All patients were on guideline-directed medical therapy (GDMT) and responded positively to the autologous cell therapy. Patients experienced increased exercise tolerance of an average of 80 seconds and an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. Sixty per cent of the patients showed substantial improvements in both measures.
These early, open-label results compare favourably to those demonstrated by current US Food and Drug Administration (FDA) approved therapies such as Ranolazine and Enhanced External Counter Pulsation (EECP). Patients already on Ranolazine experienced dramatic reduction in angina episodes at the six-month follow-up. These results are in line with previous compelling investigational trial results utilising cost prohibitive cell therapy.
“With these final roll-in results, this novel investigational therapy shows promise in addressing debilitating refractory angina, a significant unmet need for patients with chronic myocardial ischaemia,” said Carl Pepine (University of Florida, Gainesville, USA).
“We are working with our investigators to submit these results for peer reviewed scientific publication,” said Peter Altman, president and chief executive officer of BioCardia. “The results from this roll-in cohort supports our continued development of this novel therapeutic approach for chronic myocardial ischaemia with refractory angina and enhances the value of our CardiAMP cell therapy platform.”
