Peripheral Artery Disease
PAD affects approximately 8 to 12 million people in the United States. This disease is characterized by the narrowing or obstruction of the arteries in the limbs, which diminishes or prevents blood flow resulting in severe pain, difficulties with walking, non-healing wounds and, in severe cases, the need to amputate the affected limb. Based on recent studies, we estimate that there are approximately 1.5 to 2 million advanced PAD patients in the United States who would be suitable for treatment with JVS-100, if approved.
Based on our clinical and nonclinical studies to date, we have shown that inducing SDF-1 expression directly into the lower extremities of a limb affected with advanced PAD can restore microvascular blood flow by inducing the growth of new vessels and preserve tissue. We demonstrated improvement in wound healing, pain, and quality of life in our Phase 2a STOP-CLI trial. Specifically, intramuscular injection of JVS-100 into the lower limb improved blood flow and accelerated wound-healing, which we believe makes JVS-100 a potentially ideal adjunctive therapy for treating patients with advanced PAD that have non-healing wounds and that have undergone a successful revascularization procedure. A detailed synopsis of Juventas’ clinical study in PAD is available through the following link:
Building upon our prior clinical experience, we are enrolling STOP-PAD, a Phase 2b clinical trial to evaluate JVS-100 as an adjunctive therapy to below-the-knee angioplasty or bypass revascularization in patients with advanced PAD. JVS-100 is delivered by direct intramuscular injection with a needle and syringe in an outpatient setting within 48 hours after successful angioplasty, atherectomy, or bypass. The principal objective of STOP-PAD is to investigate the efficacy of JVS-100 on improving wound healing and reducing limb loss in patients who have undergone successful below-the-knee revascularization but who continue to suffer ongoing tissue loss. We anticipate that this Phase 2b study will provide sufficient data to request an end-of-Phase 2 meeting with the FDA.
Juventas has received Fast Track Designation from the FDA to develop JVS-100 for treatment of non-healing wounds in patients with advanced peripheral artery disease.
Please see the following for additional details: SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease