In the United States, over eight million adults over age 50 suffer from peripheral arterial disease (PAD), a serious condition that commonly results from progressive narrowing of arteries in the lower extremities due to atherosclerosis. PAD is associated with many adverse outcomes—including increased risk for heart attack and stroke—and is the leading cause of amputation among Americans over age 50. As the population ages, PAD is rapidly becoming a public health epidemic.
Current treatment options for PAD are limited and suboptimal. When lifestyle changes and medication are not enough, treatment often involves surgical intervention. Over 330,000 PAD-related endovascular-based procedures—such as angioplasty or stenting—are conducted in the U.S. annually, and this number is growing.1 Even when initially successful, restenosis occurs in approximately 50% of treated vessels within six to 12 months.2 To address restenosis, patients often require repeated interventions, which are associated with significant co-morbidities and healthcare costs.
Pervasis Therapeutics is developing PVS-10200 to help combat restenosis and establish healthy vasculature in patients with PAD undergoing a stent or angioplasty procedure. PVS-10200 harnesses the power of the body’s own vascular endothelium, which plays a key role in maintaining vascular health. PVS-10200 consists of tissue-engineered, allogeneic endothelium embedded in a well-characterized polymer matrix, enabling the endothelial cells to maintain their identity, viability, normal growth kinetics, and biochemical activity. Placed on the outside of the vessel at the site of intervention, PVS-10200 is believed to secrete inhibitory compounds in similar proportions to those found naturally in the body, including transforming growth factor beta-1, heparan sulfate, nitric oxide, and tissue inhibitors of matrix metalloproteinases. These compounds inhibit thrombosis, inflammation, and the proliferation of the cell layer underlying the endothelium, promoting endothelial regeneration and maintaining normal blood flow to critical organs.
A Phase 1/2 study of PVS-10200 is ongoing in patients with PAD who undergo an angioplasty and stent procedure in the superficial femoral artery. The study will evaluate the safety and the impact of PVS-10200 on the incidence of major adverse events, with initial results expected at the end of 2010. Preclinical results for PVS-10200 demonstrated that administration at the time of angioplasty and stent placement enhanced blood vessel healing compared to angioplasty and stents alone in a porcine model.3
PVS-10200 builds on the same proprietary endothelial technology and mechanism of action underlying Vascugel, Pervasis’ investigational drug for the prevention of hemodialysis access graft failure. Pervasis has received approval of a Special Protocol Assessment from the U.S. Food and Drug Administration to conduct a Phase 3 pivotal trial of Vascugel.
References
1. Centers for Disease Control and Prevention. National Hospital Discharge Survey Data, 2006.
2. Cejna M, et al. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol. Jan 2001;12(1):23-31.
3. Nugent, et al. J Vasc Interv Radiol 2009; 20(12):1617-1624.
