- Geron (GERN -13.2%) is under pressure in early trading after the company announced an update to two clinical trials assessing telomerase inhibitor imetelstat in patients with myelodysplastic syndromes (MDS) and myelofibrosis (MF).
- The Phase 2/3 IMerge study assessing imetelstat in patients with low-to-intermediate risk MDS who failed to respond to prior treatment with an erythropoiesis-stimulating agent will be amended to enroll an additional 20 patients with certain characteristics that appear to be better responders (do not have a chromosomal abnormality called del(5q) and have not received prior therapy with a hypomethylating agent (HMA) or lenalidomide). Recruitment will commence in Q4. Trial sponsor and licensee Janssen Research & Development conducted an internal data review in April and has yet to decide whether to proceed with the second segment of the study.
- The Phase 2 IMbark trial, assessing imetelstat in patients with treatment-resistant intermediate/high risk MF will continue without modification. Enrollment of new patients remains suspended since the number of current participants is sufficient to perform the primary efficacy analysis. Janssen will conduct an internal data review in Q1 2018 to enable a protocol amendment to allow long-term treatment and follow-up. Janssen will notify Geron earlier, probably in Q4, whether it intends to pursue development of imetelstat for any indication after a primary data analysis is done on IMbark (should start no later than the end of Q3).
- Now read: Medpace Holdings 2017 Q2 - Results - Earnings Call Slides
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