The stem cell research company today announced that the FDA has placed a clinical hold on its investigational new drug application for GRNOPC1, an embryonic stem cell therapy for spinal cord injury. The FDA employs this when it wishes delay a proposed trial or to suspend an ongoing one. The FDA wants to first review new nonclinical animal study data submitted by the company.
Geron was going to start testing its product on humans this summer after the FDA cleared human testing in January. It planned to inject patients with GRNOPC1 between seven and 14 days after injury and watch for improved neuromuscular control or sensation in the trunk or lower extremities. At the same time, it planned to test for patient safety. However, the testing will now be delayed during the FDA's review. Geron said it will work with the FDA, but did not estimate how long the review will take.
Since filing the IND, Geron said, it has been undertaking studies to enable dose escalation of the product. At the same time, it has investigated application of the product to other neurodegenerative diseases, performed additional product characterization, and conducted further animal studies.
On the blogosphere, some question the FDA move as a political one, while others point out that some experts predicted the demise of the research for quite some time now. Moreover, the naysayers weren't just science experts; some were also Street experts. For example, Adam Feuerstein of TheStreet.com, said in February that: "the only thing Geron has done exceedingly well in its 13 years as a public company is surf the waves of stem-cell hype and use that momentum to raise lots of money."
It will be interesting to see how future developments emerge. In the meantime, spinal cord injury patients around the world no doubt hope this was just a minor setback.