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that patients were able to have their infection-fighting white blood cells bounce back after transplant in 17.5 days. There’s no way to compare how the Fate drug did against a competing regimen, because the study had no control group, but past studies have suggested it takes 20 days for those key cells to bounce back, Fate has said.
Researchers want to see any new regimen that can help reduce the chance of transplant failure, a way to get transplants to engraft sooner, and a way to reduce the risk of a dangerous complication known as Graft-Versus-Host-Disease (GVHD), says Pratik Multani, Fate’s senior vice president of clinical development.
Fate saw enough from this mid-stage clinical study that it plans to move to the next step of clinical development in early 2012, which will include a trial from the second of three phases of clinical trials normally required for FDA approval. And while the process Fate is developing is confined to the small group of people who use umbilical cord blood for transplants, it is thought to be transferrable to the larger group of people who get more conventional bone marrow transplants from a matching donor, or get their transplant material from peripheral blood, Multani says.
The company has enough cash, Rastetter says, that it isn’t looking to raise additional money right away to finance the next steps. “We have a strong syndicate of investors around the board table, and we have no immediate plans for financing. We’ll do it as appropriate. We’re in good shape,” he says.
Fate did drop a couple of experimental drug programs earlier this year, and let go a small number of small-molecule chemists in February. The company has about 30 employees at the moment, says Scott Wolchko, the chief financial officer.
Rastetter didn’t say how long he intends to keep the “interim CEO” tag, although he did say one of his main jobs will be to recruit a full-time, permanent CEO to Fate.
“It depends on how long it will take to find a full-time CEO, but I can tell you we’re not going to compromise on quality of whoever the guy or gal is. I’m fully capable of doing this for a long time. But the beauty of Fate is that the guys around the table are all experienced, intelligent, strategic. It’s a dream team.”