Juventas recently presented the 12-month results from its Phase I heart failure trial at the 7th International Conference on Cell Therapy for Cardiovascular Disease.
The 17-person, open-label, dose-escalation study targeted New York Heart Association (NYHA) class III heart failure patients, who represent approximately a quarter of the 6 million heart failure patients in the United States and account for half of all heart failure hospital admissions. The clinical trial met its primary safety endpoint with no serious adverse events deemed drug related.
Fifteen of the 17 patients survived to a year. Importantly, patients receiving target therapeutic doses demonstrated clinically significant improvements at 12 months in 6 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 2 full classes.
"The patient population we treated in this trial have a true unmet clinical need and tend to have rapidly deteriorating quality of life," states Marc Penn, M.D., Ph.D, Founder and Chief Medical Officer for Juventas and Director of Cardiovascular Research at the Summa Cardiovascular Institute at Summa Health System. "To see clinical symptomatic benefits of this magnitude maintained from 4 to 12 months after JVS-100 treatment suggests we are inducing fundamental changes in the heart of treated patients. We believe this is consistent with our understanding of the mechanisms associated with JVS-100 and warrants further investigation."
Based on these results, the company is preparing to enroll a placebo-controlled, randomized, double blinded Phase II heart failure clinical trial in the United States to further define the efficacy of JVS-100. Also, Juventas has received FDA clearance to enroll a Phase IIa trial evaluating safety and efficacy of JVS-100 in patients with critical limb ischemia. The CLI trial is enrolling patients in the United States and India. In addition to safety, the trial will assess time to amputation and other efficacy endpoints and will begin enrollment in the first quarter of 2012.
"We are thrilled by our Phase I data and excited to be transitioning into multiple mid-stage clinical trials," states Rahul Aras, Ph.D., President and CEO for Juventas. "We are excited about the platform potential for JVS-100 in a broad range of clinical indications."