Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Geron, which has been racing to become the first biotech with a hESC therapy in clinical trials, says it was given verbal notice that regulators are putting a hold on the planned trial. The company's shares plunged 20 percent on the news.
No details were offered on the reasons for the delay, though Geron's Dr. Thomas Okarma noted that "we are disappointed with this action given the interactions we had with the FDA." Analysts also note that FDA delays can be routine and of short duration.
Advanced Cell Technology has also been in the running to launch an ESC trial, which they hope to get approval for this year.
- check out Geron's release
- read the report from the San Jose Mercury News