Photoangioplasty for human peripheral atherosclerosis - Results of a phaseI trial of photodynamic therapy with motexafin lutetium (Antrin)

Background-In photoangioplasty, light activation of a photosensitive drug o ffers the potential for treatment of long segments of vascular disease. Thi s is a brief description of a study designed to evaluate the safety and tol erability of a new photosensitizer, Antrin (motexafin lutetium), in the end ovascular treatment of atherosclerosis. Methods and Results-An open-label, single-dose, escalating drug- and light- dose study was performed in patients with atherosclerotic peripheral arteri al insufficiency. Clinical evaluation, serial quantitative angiography, and intravascular ultrasonography were performed. Therapy was well tolerated, and only minor side effects were observed. Treatment produced no deleteriou s vascular effects. Although this study was not designed to examine clinica l efficacy, several secondary end points suggested a favorable therapeutic effect. Conclusions-This phase I study demonstrates that photoangioplasty with mote xafin lutetium is well tolerated and safe. Preliminary efficacy data sugges t a future role for the treatment of flow-limiting atherosclerosis.