ARTICLE | Clinical News

Geron jumps on lift of imetelstat clinical hold

November 4, 2014 2:15 AM UTC

Geron Corp. (NASDAQ:GERN) climbed $0.57 (26%) to $2.80 on Monday after FDA lifted a full clinical hold on company-sponsored trials of imetelstat ( GRN163L), an oligonucleotide that competitively inhibits telomerase activity. The agency placed the hold in March due to signs of hepatotoxicity in a Phase II trial in essential thrombocythemia (ET)/polycythemia vera (PV) and the potential risk of chronic liver injury (see BioCentury Extra, March 12).

FDA lifted the hold after Geron submitted follow-up data from two Phase II trials of imetelstat in ET and multiple myeloma (MM). As a condition for lifting the hold, the agency had requested information regarding imetelstat-treated patients who experienced liver function test (LFT) abnormalities. Geron also supplied animal data concerning the reversibility of liver toxicity after chronic imetelstat administration. ...