BioCardia, provider of cardiovascular catheter systems designed to deliver biologic therapies for cardiac regeneration and Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, have announced that they will continue to work together to execute the Juventas’ for the treatment of heart failure.
The Food and Drug Administration has allowed commencement of the phase II safety and efficacy study and enrolment is targeted to start in the second quarter of 2012. The previous phase I trial enrolled 17 NYHA Class III heart failure patients and showed promising safety and signals of clinical benefit to the patients treated.
“JVS-100 provides the potential for an off the shelf regenerative medicine therapeutic, with the potential to significantly enhance patients lives,” said Peter Altman, president and CEO, BioCardia. “We are pleased to have the opportunity to continue to work with the Juventas team.”
“BioCardia’s Helical catheter performed well in our phase I clinical trial and is an attractive delivery system for our targeted patient population,” said Rahul Aras, president and CEO Juventas. “It is a catheter system that is simple to use with a proven safety profile and we are excited to be working with it in our upcoming phase II trial.
The Helical infusion system is a CE marked steerable two catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. It is commercially available in the European Union and is under investigation in the United States.
JVS-100 encodes Stromal-cell Derived Factor 1 (SDF-1). SDF-1 promotes tissue repair through recruitment of endogenous stem cells to the damaged organ, promotion of new blood vessel formation and prevention of ongoing cell death. The SDF-1 repair pathway is well-conserved in a broad range of end organ systems, including the heart, vasculature, dermis, kidney, and eye. JVS-100 is currently being clinically evaluated for treatment of heart failure and late stage peripheral vascular disease and has been shown to protect and repair tissue following organ damage in a broad range of pre-clinical disease models.