Juventas Therapeutics Enrolls First Patient in Phase 2 Gene Therapy Clinical Trial for Treatment of Advanced Peripheral Artery Disease

Juventas Therapeutics, Inc. will be enrolling its STOP-PAD trial, a 120-patient, placebo-controlled, randomized double-blinded Phase 2 study evaluating the safety and efficacy of JVS-100, a gene therapy encoding human stromal cell-derived factor-1 (SDF-1), in patients with advanced peripheral artery disease (PAD).
According to the press release:

STOP-PAD will be administered to patients with advanced PAD that have undergone a below the knee (BTK) revascularization procedure and are suffering with non-healing wounds often associated with this disease. Subjects will be randomized to receive JVS-100 or placebo, administered via intramuscular injection to the affected limb within 48 hours of the BTK revascularization procedure and again three months later to evaluate the potential of JVS-100 to improve outcomes. The primary endpoints for the study will be wound healing three and six month following the procedure.

Dr. John Rundback, Medical Director of the Interventional Institute at Holy Name Medical Center in Teaneck, New Jersey commented:

We are excited to be part of the STOP-PAD study and to have enrolled the first patient in this ground-breaking trial. The use of an advanced biologic as an adjunctive therapy to improve outcomes associated with below the knee revascularization is an exciting and innovative step forward for the field, and may establish a new standard of care for treating diabetic and other patients with difficult and leg-threatening vascular wounds who otherwise face the possibility of amputation.

Click here to view the full press release.