CLEVELAND, Jan. 3, 2011 /PRNewswire/ -- Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI). 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. The new trial builds on the JVS-100 cardiovascular program that includes a U.S. Phase I heart failure (HF) clinical trial for which the Company recently completed enrollment of 17 patients.
"Juventas is excited to extend its clinical pipeline to include treatment of patients with CLI," stated Rahul Aras, Ph.D., President & CEO for Juventas Therapeutics. "With our heart failure and critical limb ischemia programs moving into mid-stage clinical trials, the Company is focused on leveraging its regenerative medicine platform to address a range of cardiovascular indications with the goal of providing novel therapies to patients with limited options."
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.
"Critical limb ischemia is a devastating disease for which there is currently no FDA-approved drug for treatment," said Douglas Losordo, M.D., Principal Investigator for the trial and Director of the Feinberg Cardiovascular Research Institute at the Northwestern University Feinberg S
|SOURCE Juventas Therapeutics, Inc.|
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