First patient treated in phase II STOP-HF trial of stem cell therapy for cardiovascular disease


Juventas Therapeutics, a privately-held clinical-stage company developing novel regenerative therapies for treatment of cardiovascular disease, has announced that it has treated the first patient in its STOP-HF trial.

The 90-patient, placebo-controlled, randomised double-blinded phase II study is evaluating the safety and efficacy for JVS-100 in patients with late stage heart failure.Amit Patel, the director of Clinical Regenerative Medicine at University of Utah Medical Center, treated the patient. 

The trial is scheduled to enrol at up to 12 centres in the United States. Co-principal investigators are Leslie Miller, the chair for the College of Medicine Cardiovascular at USF Health and Warren Sherman, the director of Cardiac Cell-Based Endovascualar Therapies at Columbia University Medical Center.

JVS-100 encodes Stromal cell-Derived Factor 1 (SDF-1) which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death, and restoration of blood flow.  

Earlier this year, Juventas reported 12-month results from a phase I clinical trial in New York Heart Association (NYHA) Class III heart failure patients.  In addition to meeting the primary safety endpoint, patients receiving target therapeutic doses demonstrated clinically significant improvements at 12 months in six minute walk distance (6MWD) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ).  Nearly half of the patients improved a full NYHA class, with multiple patients improving two full classes.

The product will be delivered to patients using the BioCardia Helical Infusion System.  BioCardia is a leading provider of cardiovascular catheter systems designed to deliver biologic therapies for cardiac regeneration. 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. The Helical Infusion System is commercially available in the European Union and is under investigation in the United States in ongoing clinical trials.

“The initiation of this trial marks an important step forward for Juventas Therapeutics,” said Marc Penn, founder of Juventas and the director of the Summa Cardiovascular Institute at Summa Health Systems. “We established the company based on a hypothesis that cell therapy could be distilled down to factor-based approaches, which would be clinically-beneficial while reducing cost and complexity associated with producing and delivering adult stem cells.  It is exciting to see those early scientific discoveries translate into potential therapeutics.”