Juventas begins enrollment in JVS-100 Phase IIa study for Rutherford Class 4 or 5 CLI

Juventas Therapeutics, a privately-held, clinical-stage company developing novel regenerative therapies for treatment of cardiovascular disease, is pleased to report that it is actively enrolling patients in a placebo-controlled, randomized double-blinded Phase IIa study evaluating the safety and efficacy for JVS-100 in patients with Rutherford Class 4 or 5 critical limb ischemia (CLI).  JVS-100, the Company's lead product, 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.   

Patients are enrolling at Northwestern Memorial Hospital, Cardiology PC, Minneapolis Heart Institute Foundation, and Summa Health Systems.  In addition, the Company is enrolling patients at three leading cardiovascular institutions in India; Medanta the Medicity, Sir Ganga Ram, and Fortis Escorts Heart Institute.

"We are excited to be participating in the STOP-CLI trial," says Melina Kibbe, M.D., principal investigator for the study and the Edward G. Elcock Professor of Surgical Research at the Northwestern University School of Medicine.  "CLI is a devastating disease for which there are no good therapeutic options.  JVS-100 is a regenerative therapy with the potential to improve clinical outcomes for these patients."

There are an estimated 3 million Americans suffering with CLI.  The prognosis for these patients is 25% mortality and 35% major amputation rates within a year of diagnosis.

"Juventas is committed to developing novel regenerative therapies for life-threatening cardiovascular diseases," states Rahul Aras, Ph.D., President & CEO for Juventas Therapeutics.  "The initiation of this trial, with top-tier clinical centers, represents an exciting milestone for the Company."