Geron Corp. (NASDAQ:GERN) fell $2.71 (62%) to $1.69 on Wednesday after FDA placed a full clinical hold on company-sponsored trials of imetelstat (GRN163L). According to Geron, FDA said the hold is due to "persistent" low-grade liver function test abnormalities seen in patients in a Phase II trial in essential thrombocythemia (ET)/polycythemia vera (PV) and the potential risk of chronic liver injury. On a conference call to discuss the hold, the company said at least one abnormal liver function test has been observed in all of the patients in the trial, which completed enrollment of 20 patients in December 2012. Geron said the hold will affect eight patients in the ET/PV trial and two patients in a Phase II trial evaluating imetelstat for multiple myeloma (MM).
FDA requested information on the incidence of abnormalities in investigator-sponsored trials and the reversibility of abnormalities in all imetelstat trials. Geron said it plans to provide the information in the coming weeks. Imetelstat is an oligonucleotide that competitively inhibits telomerase activity.
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