The Niche

Halt to clinical trial for simple cysts, not treacherous teratomas

Cross-posted from The Great Beyond

Last week, the US Food and Drug Administration put the brakes on Geron Corp’s clinical trial in spinal cord injury because of just-completed animal studies that raised red flags. The Menlo, California-based biotech company announced Thursday that the animals developed microscopic cysts in the injury site. These lumps, however, did not spread to other parts of the body and none of the animals developed tumours. A second concluded study showed no cysts in spinal cord injured rats, according to a Geron press release.

“I think it provides people with a reasonable explanation,” said Stephen Brozak, an analyst with WBB Securities LLC in Westfield, New Jersey. “Everybody was afraid of the T- word, teratomas, and it clearly wasn’t that.” (Bloomberg)

Analysts rejoiced at the news. Geron shares rose more than 3% yesterday, closing higher than any day since the clinical hold was announced.

Geron is now working with the FDA to relaunch the stalled trials, the company said. No date was set.

by Elie Dolgin


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