A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients

This study is a prospective, randomized, double-blind, multi-center study, comparing MAE and WIQ rates to historical controls to evaluate the safety and efficacy of Rejuveinix for the treatment of patients presenting with symptoms as defined by Rutherford categories 4, 5, or 6, and who have undergone a successful infrainguinal percutaneous intervention within the femoral, femoral-popliteal, popliteal, peroneal, and/or tibial arteries. Treatment at or below the ankle will be permitted (e.g. pedal arteries). This intervention must be successful as defined by ≤ 30% stenosis as determined by angiographic or duplex ultrasound.

Preclinical studies support that Rejuveinix has acute perfusion properties that have the potential to provide synergistic benefits to patients after undergoing current standard of care interventional procedures.

Following an endovascular intervention, in one or more target vessels/lesions, using FDA cleared technology, such as a bare metal stent, angioplasty, and/or atherectomy, patients will receive Rejuveinix as an adjunct therapy. Enrolled subjects will be assigned randomly to one of two groups. Group A will receive two 20 mL treatments of Rejuveinix per week plus one placebo treatment per week comprised of 20 mL 0.9% saline. A dye will be added to the placebo; the dye will be selected from one found in the Orange Book. Group B will receive three treatments of Rejuveinix per week. Each 20 mL treatments will be combined with 100 mL 0.9% saline and administered via intravenous (IV) injection over the course of a minimum of 30 minutes. The study trial will occur for 12 one-week cycles with a washout period of two days between each cycle (a one-week cycle will include either 2 or 3 Rejuveinix treatments depending on the randomized group). Reven will also assess results calculated on four 21-day cycles to allow for a direct comparison to preclinical results.

The goal of the study is to demonstrate Rejuveinix treatment as an adjunctive therapy is non-inferior to historical controls in terms of patient safety, as measured by MAE rates, and efficacy, as assessed by the modified WIQ.