Progress for Pervasis and InVivo: A Boost for Regenerative Efforts?

4/19/12Follow @arleneweintraub

Last week brought good news for two Cambridge, MA companies pursuing different methods for repairing damaged body parts. Pervasis Therapeutics, which developed a cell-based method for fixing blood vessels, was acquired by Irish drug giant Shire (NASDAQ: SHPGY) on April 12. The next day, Cambridge-based InVivo Therapeutics (OTCBB: NVIV) said it expected it would soon win clearance from the FDA to begin human trials of the spinal cord injury treatment it has been working on for years.

Both companies emanated from the lab of Robert Langer, MIT professor and prolific entrepreneur (as well as one of our Xconomists), and both have experienced the ups and downs typical in the regenerative-medicine world. InVivo hoped to begin human testing of its implant for spinal cord injury patients in 2009, but was delayed by a lack of funding, as well as lengthy discussions with the FDA about the trial protocol. Pervasis raised $46 million in venture capital from the likes of Polaris Venture Partners. In 2010, the company received permission from the FDA to begin pivotal trials of its lead product, Vascugel, but it struggled to find a partner to finance the project.

For Shire, acquiring Pervasis helps to boost the drug company’s growing capabilities in cell-based therapeutics, says Kevin Rakin, president of Shire’s regenerative medicine unit. Pervasis’ technology employs endothelial cells from the lining of blood vessels to promote healing of injuries caused by inflammation, scaring, or vascular disease. The lead indication is for patients with kidney disease who are undergoing hemodialysis. Vascugel is designed to improve the function of so-called AV grafts—dialysis access points that are created by connecting veins and arteries with plastic tubes. “About 50 percent of those grafts don’t last the first year,” Rakin says. “But when Pervasis’ cells are wrapped around those access points, it improves healing. As more patients are going into dialysis, it will become more important to prevent grafts from collapsing and to extend their life.”

Rakin says Shire bought Pervasis for a modest up-front payment, plus milestone payments that could be worth up to $200 million, pending certain developmental, regulatory, and sales achievements.

Rakin adds that Pervasis is a good fit for an earlier Shire acquisition in the regenerative-medicine realm, Advanced BioHealing, which the company bought for $750 million last year. That deal brought Shire the product Dermagraft, which treats diabetic foot ulcers. “We were looking for other assets where we could apply our competencies in development, manufacturing, and sales,” Rakin says. “Pervasis provides us with another cell type that we can scale up with our expertise.”

Frank Reynolds, CEO of InVivo, says he was encouraged by Shire’s acquisition of Pervasis. “This is important for regenerative medicine,” he says. “It shows that Shire wants to be a player in cell therapies.”

InVivo has been testing a small device made of biodegradable polymers, which would be implanted within days of a spinal cord injury. The device is designed to support the spinal cord in order to lessen the potential for scarring and to promote the body’s own healing process. The company has also developed several other products, including a scaffold seeded with neuronal stem cells, which would also be used to treat spinal cord injury.

But InVivo’s first challenge will be to get its lead product into human clinical trials. Reynolds says the trial, which will involve five patients, will be largely designed to test safety and should start in the second half of this year. If all goes well, the company will plan larger trials, he says. InVivo recently met with the FDA to address several concerns the agency had. “We had to get them comfortable with the entire concept of using biomaterials in the spinal cord,” says Reynolds, who himself suffered from a spinal cord injury in 1992. He says that some of the FDA’s concerns stemmed from the travails of Geron (NASDAQ: GERN), the San Francisco company that recently bowed out of stem-cell research after years of trying to get the FDA on board with a cell-based treatment for spinal cord injuries.

Reynolds isn’t concerned. In fact, InVivo has hired several members of Geron’s clinical services team, he says, including Ed Wirth, a former medical director of Geron who is now serving as InVivo’s chief scientific officer. In late 2010, InVivo raised $10.5 million in a reverse merger and the company has seen its stock rise from 80 cents a share a year ago to $2.43. “We will end the year with about $35 million in cash, which is enough to last for three years,” Reynolds says. “Everyone here is really excited—we just want to get this study started.”

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