Several well-designed cross-sectional and case-control studies have clearly shown evidence that tHcy is a major independent risk factor for PAOD
, cardiovascular morbidity, and death (10-12).
The recurring theme in these failed trials has been that no existing treatment can increase walking distance in patients with PAD or PAOD
In mild to moderate PAOD, the increased resistance to blood flow will lead to decreased flow capacity during limb exercise which can lead to limb ischemia.
Liprostin's principal product is a prostaglandin E-1 hormone stabilized in liposome nanospheres, which Liprostin believes can become the pharmacotherapy for PAOD and more specifically, Critical Limb Ischemia (CLI) and intermittent claudication.
In this 12-patient, multicenter trial, six patients will receive a 60-minute treatment of SonoLysis (nanobubbles and ultrasound), while the remaining six will receive SonoLysis in conjunction with a small bolus of t-PA, a lytic agent that is typically administered to dissolve the blood clots that cause PAOD.
SonoLysis represents a potentially important advance in treating vascular diseases such as PAOD as it may increase safety and reduce treatment times by limiting the use of a lytic drug.
In addition to our PAOD study, SonoLysis trials are ongoing in acute ischemic stroke and deep vein thrombosis.