A Clear Clinical Focus: Improved Patient Outcomes

While surgery and devices can offer exquisite mechanical repair, they also place enormous stress on the body. Most commonly, the body’s healing processes over-react to the impact of vascular procedures, setting off an inflammatory cascade that can cause post-operative complications. To combat this harmful cascade, Pervasis is developing novel biological approaches designed to enhance the body’s natural healing response.

Following vascular surgery and intervention, the healing process is mediated by the endothelium, a layer of cells that lines the inside of all blood vessels and guides a range of critical processes, including maintenance of vascular tone, as well as thrombosis, inflammation, and cell proliferation.

Pervasis’ initial product candidates consist of a proprietary formulation of human, adult endothelial cells embedded in a bioresorbable polymer. The formulation is placed on the outside of the blood vessel at the site of vascular intervention, with the aim of down-regulating the inflammatory response, promoting proper healing, and reducing thrombosis and the formation of intimal hyperplasia. After approximately four to eight weeks, the formulation is safely resorbed by the body.

Phase 1 and 2 clinical trials of our initial product formulation, Vascugel®, demonstrated clinical proof of concept in patients with end-stage renal disease (ESRD) who require a permanent arteriovenous (AV) access for hemodialysis. In these trials, patients treated with Vascugel achieved excellent safety results and encouraging efficacy trends, including improved patency and extended time to first intervention compared to placebo. Plans are underway for a larger Phase 3 trial powered to demonstrate efficacy.

Because our endothelial formulations secrete several key factors involved in combating inflammation and restenosis, such as transforming growth factor beta-1 (TGFβ-1), heparan sulfate, nitric oxide, and tissue inhibitors of matrix metalloproteinases (TIMPs), they are applicable to other therapeutic areas beyond vascular repair, including inflammatory disease, orthopedic injury, and cancer.