Geron Corporation (GERN): The Story of the Day
Geron received really positive news this morning. The company said that the FDA has notified the company that the clinical trial hold that was placed on their Stem Cell Phase I clinical trials is now allowed to proceed.
For those that aren’t familiar why this is such positive news, let me give you the rundown on the GRNOPC1 STEM Cell Trial. Back in August of 2009, Geron disclosed that in previous animals studies using GRNOPC1 there was a “very low frequency of injected animals developed microscopic cycsts in the regenerating injury site.” Most investors, were well aware of the problem at the time, however the company also announced that a more recent study showed a “higher frequency of cysts, although their characteristics were similar to the cysts seen in previous studies.” The company said that these cysts were confined to the injury site and were smaller than the injury cavity and also were not associated with adverse clinical outcomes.
So what is the problem here? Why the Hold?
Well, we are entering unchartered territory here. The FDA usually has a set procedure with how to move forward, but with Stem Cells, the regulatory body is cautious as to how to proceed. So they decided to put a hold on the Company’s Phase I clinical trial in Spinal Cord Injury patients.
cont’d on next page
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