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