Geron has quit on embryonic stem cells. The company is abandoning its world-leading clinical trial, aimed at using stem cells to treat people paralyzed with spinal-cord injuries. It is laying off more than a third of its staff, and is writing off about $8 million. It has also repaid the California Institute of Regenerative Medicine (CIRM) a loan of more than $6 million, plus interest. Geron will continue to monitor the four patients currently enrolled in the phase 1 clinical trial, and says it is looking for another company to take it over.
The decision to terminate the trial seems to be all business, a departure from past practices that seemed motivated more by hype and wishful thinking. Geron's stock has been plummeting (down from $6.34 to $1.60 over the year), and new management is conducting triage. The ESC trial is only in phase 1, a safety trial, in which severely injured patients receive low doses of treatments that are frankly unlikely to do much good; the point is to ensure that they do no harm. Results from that are not expected till 2014, but the company has two cancer drugs in phase 2 clinical trials, which should be completed by early 2013. The brutal truth is that the company may run out of money if it tries to maintain all three projects.
Geron has been in trouble for a while. Former CEO Thomas Okarma, who left abruptly in February, was the subject of ridicule for his repeated announcements that ESC-based clinical trials would begin "next year" — that is, 2005, 2006, 2007, 2008 — and the trial they eventually came up with was so dubious that Arthur Caplan called it "nuts and hugely risky." Even experts in the field thought that targeting spinal cord injury in the first ESC trial was dubious, though some seem to be more willing to be critical now it has ended.
Posted in Biotech & Pharma, California, Patents & Other IP, Pete Shanks's Blog Posts, Stem Cell Research
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