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Pervasis Receives Orphan Drug Designation in Europe for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Date:3/1/2011

dditional, recurring surgeries to create a new access which can lead to multiple complications. Up to 60 percent of all arteriovenous (AV) grafts require re-intervention after one year.(1,2) AV access failure is the most common reason for hospitalization among hemodialysis patients and can lead to anemia, infection, weight loss, jaundice, prolonged bleeding, and other serious complications.(3)

Vascugel® – Combating Inflammation and Promoting HealingPervasis' novel approach to cell therapy uses adult-differentiated allogeneic endothelial cells (donor endothelial cells with a highly targeted biologic function) embedded in a polymer matrix to enhance the body's natural healing response. The endothelium is the thin layer of cells that lines the interior surface of blood vessels in the body. Endothelial cells are critical to tissue repair and health, and have a well-understood role in regulating many of the body's healing processes, including those associated with vascular repair.

Vascugel, which utilizes Pervasis' patented endothelial cell-based platform, is placed on the outside of the blood vessel at the AV access site during the surgical intervention to create the access. The endothelial formulation in Vascugel secrete several factors that combat inflammation and promote proper vascular healing, reducing thrombosis (or clotting) and the formation of intimal hyperplasia, or a thickening of the blood vessel wall in response to injury. After approximately four to eight weeks, Vascugel is safely resorbed by the body.

Pervasis' other areas of clinical investigation include improving outcomes in patients with peripheral artery disease (PAD) following surgical procedures such as percutaneous transluminal angioplasties (PTAs) with stenting, the failures of which result in serious complications and a significant increase in medical costs. Earlier this year, Pervasis announced it has also embarked on an oncology development program using it
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SOURCE Pervasis Therapeutics, Inc.
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1. Pervasis Receives FDA Fast Track Status for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
2. Pervasis to Present Interim Data from Phase 1/2 Clinical Study of Novel Cell Therapy Targeting Peripheral Artery Disease at International Conference on Cell Therapy for Cardiovascular Diseases
3. Pervasis Therapeutics to Develop Novel Cell-Based Approach to Target Tumor Environment, Prevent Cancer Recurrence
4. Pervasis Therapeutics Awarded Four Grants Under the Qualifying Therapeutic Discovery Project
5. Pervasis Therapeutics Receives FDA Clearance for Pivotal Phase 3 Trial of Vascugel(R)
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