FDA ISSUES VERBAL HOLD FOR GERON’S IMETELSTAT APPLICATION
Geron has been given verbal notification from the U.S. Food and Drug Administration (FDA) that its application for imetelstat has been placed on full clinical hold, affecting all ongoing company-sponsored clinical trials. A full clinical hold is an order that the FDA issues to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial.
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. Geron released a statement as well as a recording of a conference call to go over details.
This comes only a few months after Sanofi’s clinical trial was discontinued due toneurotoxicity issues.