BioCardia and Juventas Announce Phase II Development Program of JVS-100 delivered with the Helical Infusion System to treat Heart Failure
San Carlos, CA -
March 14, 2012
BioCardia, a leading 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, announced today that they will continue to work together to execute Juventas’ Phase II trial of JVS-100 for the treatment of heart failure.
The Phase II safety and efficacy study has been allowed by the Food and Drug Administration and enrollment is targeted to start in Q2 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,” states Peter Altman, Ph.D., BioCardia’s President & CEO. “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”, states Rahul Aras, Juventas’s President and CEO. “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.
BioCardia, Inc., headquartered in San Carlos, CA is a privately-held commercial medical technology company that has developed percutaneous delivery systems for biologics to treat cardiovascular disease. The company's initial products are intended to provide a new therapeutic option for patients with heart failure and chronic myocardial ischemia.
About the Helical Infusion System
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 requires no external capital equipment and has an excellent clinical safety profile. The Helical Infusion System is commercially available in the European Union and is under Investigation in the United States in ongoing -clinical trials.
About Juventas Therapeutics
Juventas Therapeutics, headquartered in Cleveland, OH, is a privately-held clinical-stage biotechnology company developing a pipeline of regenerative therapies to treat life–threatening diseases. Founded in 2007 with an exclusive license from the Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to initiation of mid-stage clinical trials.
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.