Following closely on the heels of the pioneering embryonic stem cell company Geron, Advanced Cell Technology says it has gained FDA approval to launch the second human study of an ESC therapy. ACT, which has been struggling for years to get into the clinic, plans to test its treatment on a handful of patients with Stargardt's macular dystrophy, a rare and progressive form of blindness.
"It is exciting--a vindication. All this work really came through," Robert Lanza, the Marlborough, MA-based company's chief medical officer, told Reuters.
ACT survived a near-death experience back in the summer of 2008. Stymied in its work and short on cash, its stock had fallen to 2.5 cents as analysts calculated how much time it had left on the clock. Shares now trade for a little more than six cents a share, up more than two cents this morning.
"I think this marks the beginning of a new era for stem cell research," Lanza, who's never been shy about touting the field, told the Washington Post. "After a decade of intense controversy, the field is finally ready to prove itself--and to actually start helping patients suffering from a range of horrific diseases. It also shows the new readiness of the FDA to work with researchers to move exciting new stem cell therapies out of the laboratory and into the clinic."