By: Adam Feuerstein | 03/12/14 - 09:57 AM EDTUpdated from 6:14 am EDT with new information.
Geron(GERN) received a call from the FDA yesterday which no drug developer ever wants: A full clinical hold has been placed on its lead drug imetelstat due to concerns about liver toxicity.
The FDA-mandated full clinical hold requires Geron to suspend enrollment in all of its imetelstat clinical trials.
The clinical hold affects the remaining eight patients in the company`s Phase 2 study in essential thrombocythemia (ET) or polycythemia vera (PV) and the remaining two patients in the company`s Phase 2 study in multiple myeloma. In addition, the company's planned Phase 2 clinical trial in myelofibrosis will likely be delayed due to the clinical hold. It is possible that other studies using imetelstat, such as ongoing investigator-sponsored trials, may also be placed on clinical hold by the FDA.
Drug development would be so much easier if people didn't have livers. Adam Feuerstein (@adamfeuerstein) March 12, 2014Update: On a conference call this morning, Geron said the FDA concerns relate primarily to reports of "persistent" low-grade elevations in liver enzymes reported by almost all imetelstat-treated patients. Regulators want Geron to submit clinical data on the reversibility of these liver toxicity signals.
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