Geron, the company that helped pioneer research embryonic stem (hES) of human cells, said yesterday that it stops its first-in -the-world clinical trial and pulling further work on stem cells. The company, based in Menlo Park, California, will instead focus on its cancer therapies, CEO John Scarlett said in a statement. "Deciding to leave the company on stem cells was a very difficult decision," he told investors and reporters this morning.
Geron helped finance the work of James Thomson at the University of Wisconsin, Madison, who in 1998 was the first to isolate hES cells. The agreement gave the company exclusive licenses for a number of hES cell patents. Last year, he launched the first clinical trial in the world, was designed to treat eight patients with spinal cord using neuronal cells derived from hES cells. Four have been treated so far, and Geron says it will continue to follow them. However, it will not enroll new patients ,. The company returned a $ 6.5 million loan from the California Institute for Regenerative Medicine (CIRM), an organization funded by taxpayers set up to support research on stem cells, in particular hES cells. CIRM agreed earlier this year to pay Geron up to $ 25 million to finance the trial.
Scarlett, who joined the company in late September, said the decision enables Geron to continue to operate without raising new funds for the next year and a half when he awaits the results of a half dozen phase II trials of two drugs against cancer. As part of the downsizing on stem cells, the company will reduce by 66 full-time positions, 38% of its workforce.
Stephen Kelsey, medical director of Geron, told the conference that patients to date have shown no significant side effects or no improvement in their condition. Given the small scale of the study, he said, early cessation may not be such a loss. "We requested and received permission to run a very small safety study with a low dose of cells," he said. "We are half-way, and the data were remarkably consistent. We will be presenting the results, and it will be a fair reflection of what would have happened if we had completed the study. "
Some observers have expressed reservations about the trial from the beginning, worrying that animal results are not strong enough to justify a human trial. But many were pulling for the company all the same. "It is with a sense of loss that I see this news," said Roger Pedersen of the University of Cambridge, UK, who was one of the researchers receive funding from Geron in mid-190 to try to obtain hES cells. He said the company can respond not only to the long timeline to bring cell therapies to the clinic, but also a possible weakening of its intellectual property portfolio. the development of induced pluripotent stem (iPS) cells, which are adult cells reprogrammed genetically to resemble those embryonic, meaning that exclusive licenses Geron can worth less. "The progress in the field of stem cells are disruptive innovations that have the potential to supercede previous innovations, hES cells being one of them. I do not know if Geron looks that way, but I do" said Pedersen.
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