Imetelstat: Phase II resumed

Geron said FDA lifted a full clinical hold on company-sponsored trials of imetelstat, including a Phase II trial to treat essential thrombocythemia (ET)/polycythemia vera (PV) and a second Phase II trial to treat MM. The agency placed the hold in March due to signs of hepatotoxicity in a Phase II trial in ET/PV and the potential risk of chronic liver injury (see BioCentury, March 17). FDA lifted the hold after Geron submitted follow-up data from the 2 Phase II trials of imetelstat in ET and MM, information regarding imetelstat-treated patients who experienced liver function test (LFT) abnormalities and animal data concerning the reversibility of liver toxicity after chronic imetelstat administration. ...