CellProthera & BioCardia Collaborate on Successful Phase 2 Trial of ProtheraCytes for the Treatment of Acute Myocardial Infarction

CellProthera and BioCardia Inc. recently announced success from a collaborative Phase 2 trial of ProtheraCytes for the treatment of acute myocardial infarction (AMI) led by CellProthera, as well as plans to continue the relationship into Phase 3.

CellProthera’s clinical results from the Phase 1/2b EXCELLENT Trial, which studied the feasibility of transendocardial injection of ProtheraCytes for acute myocardial infarction when delivered in combination with the standard of care, suggested an effective solution for preventing heart failure progression in the patients at high risk following a heart attack

The ProtheraCytes, which are autologous, expanded CD34+ stem cells, were well tolerated with no unexpected serious adverse events reported. Transendocardial administration of ProtheraCytes, performed utilizing the percutaneous catheter delivery system from BioCardia, was associated with improvements in multiple efficacy endpoints including a significant improvement of the viability of segments from baseline to 6 months, a consistent positive trend of improvement of LV volumes at 6 months, and a faster decrease in an important biomarker of heart failure, NTproBNP.

“The promising results of the study confirm the potential of our therapy to provide an effective one-off solution to prevent heart failure progression in AMI patients,” said Matthieu de Kalbermatten, CEO, CellProthera. “We are actively planning for what comes next and we have valued the responsiveness of the BioCardia team throughout the EXCELLENT trial in supporting training, attending clinical cases, and providing delivery systems. We have great learnings today that will enhance our efforts in what comes next, together.”

“The EXCELLENT trial has meaningful results for patient benefit using an approach that we feel makes enormous sense for locally administered high effective dosage of autologous CD34+ cells for these patients,” added Peter Altman, PhD, President and CEO of BioCardia. “I am personally impressed by their approach. It has been an honor to support CellProthera and we look forward to collaborating in the study to follow. We are ready for what comes next with enhancements to our delivery capabilities.”

CellProthera is a regenerative cell therapy developer specializing in cardiovascular diseases with a leading program in myocardial infarction. CellProthera has developed a unique GMP-compliant cell expansion process as well as a proprietary automation technology for in vitro production of large quantity of purified, CD34+ stem cells. Its lead therapy ProtheraCytes™, is an autologous cell therapy and has been developed for body regeneration and targeted to regenerate various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product by the European Medicines Agency (EMA). CellProthera’s proprietary technology platform comprises an automated expansion device called StemXpand® and its disposable kit StemPack®. CellProthera is headquartered in France. www.cellprothera.com/en/home

BioCardia, Inc., is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs. www.biocardia.com