Juventas Therapeutics announced that the FDA has authorized commencement of its Phase 2 trial of JVS-100 for the treatment of critical limb ischemia (CLI). The randomized, placebo-controlled study will evaluate the efficacy and safety of JVS-100 in 48 patients (36 JVS-100 treated; 12 placebo) with Rutherford Class IV or V CLI. The clinical trial will measure several efficacy endpoints including time to amputation, transcutaneous oximetry (TcPO2), Ankle-Brachial Index (ABI) and ulcer closure.
JVS-100 encodes Stromal-cell Derived Factor 1 (SDF-1), which has been shown in several pre-clinical studies to promote tissue repair through activation of natural stem-cell repair pathways, promotion of new blood vessel formation and prevention of on-going cell death.
For more information call (216) 445-0830 or visit www.juventasinc.com.