CLEVELAND, May 15, 2012 /PRNewswire-USNewswire/ -- 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."
The STOP-CLI Trial
The STOP-CLI Trial (Sdf-1 plasmid Treatment fOr Patients with Critical Limb Ischemia) is a dose-ascending, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of JVS-100 treatment in patients with Rutherford class 4 or 5 CLI.
Patient outcome measures include safety, time to amputation, wound closure, TcPO2, ankle-brachial index (ABI) and toe-brachial index (TBI)
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 for treatment of heart failure and critical limb ischemia. Investors include New Science Ventures, Takeda Ventures, Triathlon Medical Venture Partners, Early Stage Partners, Fletcher Spaght Ventures, Reservoir Venture Partners, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received non-dilutive grant support through the Ohio Third Frontier funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center and Center for Stem Cell & Regenerative Medicine.
SOURCE Juventas Therapeutics