MULHOUSE, France & SAN CARLOS, Calif.--(BUSINESS WIRE)--CellProThera® and BioCardia® today announced an agreement to partner on the EXCELLENT (Expanded Cell Endocardiac Transplantation) Trial, a multi-center, controlled Phase I/IIb study to evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process and delivered via the BioCardia Helix™ Transendocardial Delivery System.
The agreement calls for milestone payments to BioCardia, which are creditable to a future clinical development program, and milestone payments to CellProThera for timely completion of the Phase II study.
“We look forward to taking the next step in demonstrating the safety and efficacy of our promising CD34+ therapy in a Phase II trial,” said CellProThera President and Chief Scientific Officer Philippe Henon, MD. “Partnering with BioCardia, we will be able to safely and effectively deliver our therapy directly to diseased areas of the heart that need it the most, using a system with a safety profile that has been proven in seven clinical trials to date.”
“The potential of the CD34+ therapy is very exciting and has been demonstrated using surgical intramyocardial delivery,” said BioCardia Chief Executive Officer Peter Altman, PhD. “We look forward to partnering with CellProThera to deliver a procedure proven to be safe in all of our other clinical trials to patients in the EXCELLENT Trial by enabling less invasive, transendocardial delivery using our proprietary Helix technology.”
The trial will study patients with an acute myocardial infarction (AMI) and a left ventricle ejection fraction (LVEF) remaining below or equal to 45 percent after percutaneous transluminal coronary angioplasty (PTCA) and stent(s) implantation versus standard of care. The study will encompass 44 patients treated at up to eight centers in the United Kingdom and France and followed for six months. Co-principal investigators are Jerome Roncalli, MD, PhD, Department of Cardiology, University Hospital of Toulouse, France, and David E. Newby, MD, PhD, University Centre for Cardiovascular Science of Edinburgh, Scotland.
The primary endpoint of the study is no treatment emergent major adverse cardiac events (MACE) at 30 days post-procedure. Secondary endpoints will assess the first efficacy trends, the viability of the infarcted segments, safety of the Helix transendocardial delivery procedure and quality of life.
A French pilot study demonstrated both a functional and structural regeneration of the cardiac lesion in patients with AMI after direct intracardiac re-injection of autologous peripheral blood (PB)-CD34+ stem cells. However, the necessity for leukapheresis sessions and an open surgical procedure were challenging for patients and could only be performed in a few specialized centers. In order to simplify and standardize the cell graft production process, CellProThera developed an Automated Process using a cell expansion automate StemXpand® and disposable kit StemPack®. This enables GMP production of as many stem cells as those obtained with one leukapheresis, starting from a whole autologous blood sample simply drawn after G-CSF mobilization, thus avoiding leukapheresis sessions. In pre-clinical studies, the expanded CD34+ cells (Protheracytes®) have demonstrated the same therapeutic efficacy as naive cells with no chromosomic alteration, toxicity or tumorogenicity.
The Helix Transendocardial Delivery System is a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. The system’s unique performance advantages include crossing the aortic valve over a wire to prevent damage; enhanced navigation using the company’s steerable Morph® guiding catheter; a helical needle which screws into the myocardium for stable delivery; and the use of contrast at the base of the needle to confirm tissue engagement. The Helix system has received CE Mark and is commercially available in the European Union. It is currently being used for investigational biotherapeutic programs in the United States and is not approved for sale in the U.S.
CellProThera, headquartered in Mulhouse, France, is the first company having conducted successful proof of principle study with autologous CD34+ stem cells to repair myocardial tissue after acute myocardial infarct (AMI). The clinical outcome indicated an excellent safety profile associated with outstanding clinical benefits. The innovative approach developed by CellProThera is viewed by experts as one of the most effective to treat AMI. This “rupture” therapy represents a unique alternative to cardiac transplant and can be a complement and/or a substitute for existing therapies like coronary bypass surgery and stenting.
BioCardia, Inc., headquartered in San Carlos, CA, is a privately held company developing integrated regenerative medicine therapies to treat cardiovascular disease. The Company's commercial products include the Helix™ Transendocardial Delivery System and the Morph® steerable guide and sheath catheter portfolio. BioCardia partners with other biotherapeutic companies to provide its Helix system and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.