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ARTICLE | Clinical News

Imetelstat: Additional Ph II/III IMerge data

April 13, 2017 3:47 PM UTC

Geron said based on second internal review of data from about 30 patients in the Phase II portion, a joint steering committee recommended continuation of the international Phase II/III IMerge trial evaluating IV imetelstat at a starting dose of 7.5 mg/kg every 4 weeks in patients with low or intermediate-1 risk MDS that is relapsed or refractory to ESAs. The committee evaluated 8- and 24-week data on transfusion independence and hematologic improvement by erythroid (HI-E) response, and determined that the benefit/risk profile of imetelstat supports continued development in lower risk MDS. The Phase II portion is fully enrolled and will continue unmodified.

Geron said Johnson & Johnson's Janssen Biotech Inc. unit will determine whether or not to initiate the double-blind, placebo-controlled Phase III portion of the trial. If the pharma decides to proceed, Geron expects the Phase III portion, which would enroll about 170 patients, to begin in 4Q17. ...

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