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"The blood-vessel wall is a complicated structure," says Elazer Edelman, director of the Harvard-MIT Biomedical Engineering Center and cofounder of Pervasis. When the endothelium is damaged, it leads to a condition called intimal hyperplasia--an abnormal growth of smooth muscle cells. The vessel walls then scar and thicken, leading to restenosis.

The Pervasis product contains endothelial cells grown from culture. The factors released by the cells "send the signal that the endothelium is okay, that it's in control," says Pervasis CEO Steve Bollinger. It gives the endothelium time to heal itself. The gel biodegrades after 30 to 60 days.

Vascugel has demonstrated proof of concept in two Phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous (AV) access in order to undergo hemodialysis. In these trials, Vascugel exhibited an excellent safety profile, and encouraging efficacy trends were observed, including improved duration of patency (or unimpeded blood flow) and a delay in time to first intervention as compared to placebo.

In 2009, Pervasis received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Vascugel in patients with ESRD. Pervasis announced last month that the FDA had granted Fast Track review status for Vascugel. Last year, Pervasis reached an agreement with the FDA for a Phase 3 clinical trial of Vascugel under the Agency’s Special Protocol Assessment (SPA) procedure, whereby FDA formalized its agreement that the design
of the Phase 3 trial was acceptable to support a regulatory submission seeking new drug approval.

To receive Fast Track designation, a product must address a serious unmet medical condition, and be supported by strong results from pre-clinical or clinical testing demonstrating the product potential.

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has signed an agreement to acquire substantially all the assets of Pervasis Therapeutics. Shire will provide Pervasis with an upfront payment, plus potential post-closing milestone payments that are dependent on Shire’s achievement of certain clinical development, regulatory and sales targets.