Date: 2014-09-15
Type of information: Clinical research agreement
Compound: protheracytes® CD34+ cells delivered by Helix™ transendocardial delivery system
Company: BioCardia (USA - CA) CellProThera (France)
Therapeutic area: Cardiovascular diseases
Type agreement: clinical research
Action mechanism: cell therapy. Protheracytes® are expanded CD34+ cells. 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.
Disease: acute myocardial infarction
Details: * On September 15, 2014, CellProThera and BioCardia 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 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.
Financial terms: 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.
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