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Clinical Trials

FDA authorizes Juventas to initiate CLI Phase II trial

PBR Staff Writer Published 03 January 2011

The US Food and Drug Administration (FDA) has authorized Juventas Therapeutics to initiate a randomized, placebo-controlled Phase II clinical trial to investigate the efficacy and safety of JVS-100, as a treatment for critical limb ischemia (CLI).

The clinical trial will measure several efficacy endpoints including time to amputation, transcutaneous oximetry (TcPO2), Ankle-Brachial Index (ABI) and ulcer closure.

Juventas said that 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.

Juventas president and CEO Rahul Aras said that Juventas is excited to extend its clinical pipeline to include treatment of patients with CLI.

Juventas chief medical officer Marc Penn said that they believed that if they could identify the molecular factors that activate this pathway, they could be delivered at a time post-injury to promote tissue preservation.