Friday, August 15, 2008

Pervasis goes old school with cell-transplant tech

By Stephen DeSantis

With so much attention — and funding — focused on emerging biotech treatments using RNAi, stem cells and gene transfer technology, Pervasis Therapeutics Inc. is working to rejuvenate good old-fashioned cell transplantation technology.

The Cambridge company is pinning its hopes on two completed Phase 2 clinical trials that studied its Vascugel treatment on vascular access failure in patients with end-stage renal disease.

Unlike more novel biotechnologies, such as RNAi, cell transplantation has been around for years, but has slipped out of favor after triggering immune rejection in patients. What makes Pervasis’ technology so different isn’t necessarily what it does, but what it does not do. It manages not to trigger massive immunoreactivity.

Pervasis develops regenerative therapeutics using a tissue transplant technology that involves placing donor cells into a specially designed gel, or matrix. These cells release proteins that promote healing. The result is a product, called Vascugel, that can be used to heal tissue, or prevent complications after trauma or surgery. The matrix could also limit scar tissue, inflammation and thrombosis.

The aim in kidney disease is to help ease the burden on patients dealing with issues associated with dialysis treatment. Vascugel is designed to decrease graft failures, maintaining unobstructive blood flow.

Pervasis’ ability to move ahead with Vascugel will depend on the trial results due before the end of the year.

The company also is looking at new uses for its tech in nonvascular applications such as organ transplantation, wound and bone repair, and oncology. Military uses for wounds or during surgery are also being explored.

Even as innovative approaches to tissue and organ transplantation have been attempted, immune rejection issues have always plagued them. And prolonged use of immunosuppressants — lifelong in some cases — is costly and can leave the body open to infection.

“Where we’re looking is where pharmaceutical drugs and devices have fallen short,” said Stephen Bollinger, chief operating officer at Pervasis.

He described the development of the drug-coated stent as a convergent opportunity for treating an area locally with a drug that otherwise would be introduced via the bloodstream, which can cause unwanted side effects. A drug within an implantable device was revolutionary in the early 1990s.

“Finally, you got a localized approach using a drug. But it turned out there are serious challenges with that technology, too, in terms of toxicity and other issues,” said Bollinger, who has 15-plus years of experience in the medical device world.

Pervasis was founded in 2004 by internationally renowned scientists and biotech entrepreneurs in the areas of regenerative medicine, medical devices and tissue transplantation, including Elazer Edelman, Robert Langer, Joseph Vacanti and Helen Nugent.

The company came out of the Deshpande Center for Technological Innovation at MIT. Edelman performed the early research on Vascugel. He is now the head of the Harvard-MIT Biomedical Engineering Center and a cardiologist at Brigham and Women’s Hospital.

In January, Pervasis secured $9.75 million in Series B funding from Flagship Venture Partners, Polaris Venture Partners, Highland Capital Partners, and Musket Research Associates.