Juventas Therapeutics, a clinical-stage regenerative medicine company that develops therapies for cardiovascular disease, has completed a phase I clinical trial evaluating the safety and preliminary efficacy of JVS-100 for treatment of patients with heart failure. 

The trial enrolled 17 New York Heart Association Class III heart failure patients, with left ventricular ejection fractions less than 40% and an average time from heart attack of 7.3 years.  Three escalating JVS-100 doses were evaluated: 5 mg (cohort 1), 15 mg (cohort 2) and 30 mg (cohort 3).  The primary safety endpoint was the number of major adverse cardiac events (MACE) at 30 days. Efficacy was assessed as changes from baseline in: echocardiographic parameters, cardiac perfusion via SPECT and clinical parameters including NYHA class, 6 minute walk distance (6MWd) and quality of life score (QOL).  Safety data has been collected for all 17-patients and 4-month efficacy data has been collected from cohort 1 and 2 patients.

The primary safety endpoint for the trial has been met with no adverse events likely related to drug.  At 4 months post-therapy, patients are demonstrating dose-dependent improvements in all clinical parameters with clinically relevant improvements compared to baseline in QOL and 6MWd for patients from cohort 2.  At 1-month after dosing in cohort 3 patients are showing similar clinically relevant improvements in QOL and 6MWd with some patients improving a full New York Heart Association class.