After reviewing his information on the reversibility of hepatotoxicity, the FDA notifies the Mayo Clinic's Dr. Ayalew Tefferi that the partial clinical hold it placed in March on his investigator-sponsored clinical trial of Geron's (GERN) imetelstat as a treatment for myelofibrosis has been lifted. The hold was partial because patients who were deriving a clinical benefit from imetelstat continued receiving treatment. The clinic stopped enrolling new patients in January but it did not cite safety concerns as a basis for its decision.
Geron's IND for imetelstat remains on full clinical hold. This affects its clinical trials in essential thrombocythemia or polycythemia and in multiple myeloma. The company cannot submit any new clinical trial protocols until the hold is lifted. It is working diligently to rectify the situation.
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