Geron Corporation (NASDAQ:GERN) released updates on recent events. Commenting on Imetelstat Clinical Development, the company said that imetelstat is being assessed in two current clinical studies, IMbark and IMerge, as performed by Janssen under the terms of a global license and collaboration deal.
Geron reported that IMerge is a Phase 2/3 clinical study intended to assess imetelstat in transfusion dependent people with intermediate-1 risk or IPSS low myelodysplastic syndromes who are refractory to or have relapsed after prior treatment with an ESA. IMbark is a Phase II clinical study intended to assess two dose levels of imetelstat in people with intermediate-2 or high risk MF who are refractory to or have relapsed after prior therapy with a JAK inhibitor.
Last April, the second internal report reviews of IMbark and IMerge were completed. Depending on these assessments, the Joint Steering Committee decided that both studies continue unmodified, and subjects remaining in the therapy stages may continue to get imetelstat, whose safety profile in both studies were consistent with previous clinical studies of imetelstat in hematologic distortions, and no new safety indications were known.
For IMerge, the risk/ benefit profile of imetelstat in the Phase II subjects supports continued advancement in lower risk MDS. A planned design refinements and data package to the Phase III component of the study are intended to be offered to the FDA. Moreover, the Phase II report from IMerge is anticipated to be filed for presentation consideration at a medical conference in the imminent period.
Geron reported that for IMbark, the existing report indicate clinical benefit and a prospective overall survival benefit linked with imetelstat therapy in relapsed or refractory MF. Registration of new subjects to the study remains suspended as the total count of subjects registered to date is adequate to evaluate longer-term outcome initiatives, including OS, when the report is fully matured.