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"We're still proving our supposition that these cells are safe," he says, with a deep sigh that suggests he's covered this terrain many, many times. "But the upside is worth the risk. When you think of the number of problems we can address using cellular therapy, it's mind-boggling. It's vision, it's hearing, it's spinal cord injury, Huntington's, stroke, Parkinson's, epilepsy, Alzheimer's." Wink. "Potentially, it's a real home run."
Snable gave the company the maiden name of his mother, who died of Alzheimer's a year before he and researchers at the University of Pennsylvania formed Layton. "We thought it might be nice to name the company after her, rather than Neuroscience Company Number 43 or whatever," he says.
Ten years later, everyone in the cellular therapy field knows Layton's name. Layton has the only human cancer cell that can be differentiated into neurons, which can then be produced in large quantities. Despite the success in the laboratory, however, Snable has had less luck in the boardroom.
"Though venture capitalists like to consider themselves venturesome, few are," says Snable, who calls fund-raising his priority, not his greatest joy. "They like to invest in something that's been proven a little bit and tweaked, rather than something that's unproven. And with anything that's new, there are no guarantees. When you don't get funded, it's like a house sitting on the market for a long time.
"People look at it and say, "It sounds good to me, but there must be something wrong with it. Why haven't they raised the money?'"
Toucan Capital Corp. of Bethesda, Md., is one of the venture capital firms that took a chance on Layton, contributing $3 million. "We specialize in early-stage investing, so we have nerves of steel and stomachs of iron," says Linda Powers, a managing director with Toucan. "They're way, way out in front of everybody else. They've been working on it for 10 years and they're actually getting somewhere."
Although still not profitable, Layton finances much of its research through the sale of Inversine, a nicotine substitute that battles Tourette's syndrome. Astonishingly, Layton expects to go commercial with LBS-Neurons in the fourth quarter of 2004. But even Steinberg says it's too early to know whether that target date is realistic. "I don't know that we can say we'll be treating patients in a few years with this cell line," he says.
Despite outside criticism of the company's push to enter human clinical trials, doctors working with Layton insist the firm is moving cautiously. Dr. David Tong, a Stanford neurologist who conducts patients' physical therapy evaluations, admits he has "huge safety concerns" about administering the formerly cancerous cells. But he defends the pace and precaution of the study.
"Stroke has been a problem for thousands of years -- we're not going to cure it in five," Tong says. "The company, to its credit, has been good about listening to the scientific advisers. Everybody wants to go as fast as possible. Fortunately, they've used academic centers to run these trials. Too many times, these drug companies push their own agendas, and the academics are taken along for a ride. That's not the case here."
If Layton ever wants a reminder to proceed with care, it need look no further than Charlestown, Mass. That's the home base of Diacrin Inc., a biotech firm that launched a clinical study in September 1999 to treat stroke patients with fetal pig cells. But after surgeons implanted the cells in just five patients, one experienced brain swelling and another suffered severe seizures. The company blames the large tube it used to inject the cells, but the FDA halted the trial in the spring and has not allowed it to proceed.
Matt Fredericks limps through the door of Stanford Medical Center's neurology department and exclaims, "Hi honey, I'm home."
Today, home is a drab exam room with the requisite table/bed, sink, latex-glove dispenser, and poster on the wall extolling the benefits of anti-epileptic drugs. From 9 a.m. until late afternoon, Fredericks is prodded, questioned, and tested. Dressed in a tan jacket, tan button-down shirt, and tan slacks, Fredericks -- a slight man with a mustache and cropped brown hair -- responds to the evaluations with a healthy dose of sarcasm. When a nurse asks if his vision is blurry, Fredericks replies: "Only when I take my glasses off." He compares the wait line snaking out of the Blood Drawing and Specimen Collection Lab to the crush of bodies waiting for a spot on one of the Titanic's lifeboats. When a doctor hands Fredericks a copy of Islands magazine and asks him to describe the cover photo of three scantily clad Polynesian women steering a raft, his insight consists of: "Beautiful composition."
But away from the spotlight, Fredericks makes it clear that his attempts at comedy are merely a means of coping, not a sign that he's approaching the study with a cavalier attitude. Fredericks, an engineer who lives in Southern California, was only 35 when he had his stroke five years ago. Thoroughly unprepared for the deep bouts of depression that followed, Fredericks descended into suicidal despair.
"Why, when you're committing suicide, do you put five rounds in the chamber? It's only going to take one click, and all that suffering and misery will be over." As he waits to have his blood drawn, and for the STAT! notation on his form to register with the receptionist, Fredericks stuffs his dead left arm into his pants pocket and lowers his voice. "The stroke takes away so much of you, but it leaves just enough to realize your life is over. Three months after the stroke I sat there with a handgun to my head. I have a wife and two children, but you're living in misery, and they're living in misery ... it'll just take a second to pull the trigger. And having been down the path of suicide, it still lurks, it still sits there as you go to tie your shoe and you realize you can't."