Geron Corporation GERN announced that it has started enrollment in the phase III IMerge study, evaluating its sole pipeline candidate, imetelstat, for treating hematologic myeloid malignancy, myelodysplastic syndromes (“MDS”).
The phase III study will enroll a total of 170 patients from a targeted patient population with lower risk MDS and are naive to treatment with hypomethylating agents (HMAs) and lenalidomide as identified in the phase II portion.
Shares of Geron were up almost 1.4% in after-hours trading on Oct 10, following the announcement. So far this year, the stock has gained 44% against the industry’s 8.9% decrease.
Myelodysplastic syndromes represent a group of diverse blood disorders, which develop as bone marrow cells fail to mature into healthy blood cells. This leads to requirement of blood or red blood cell transfusions in patients. However, serial transfusions can lead to iron overload, heart and kidney complications and may lead to shorter overall survival.
The primary endpoint of the IMerge study is the proportion of patients achieving transfusion independence over the eight weeks period of treatment duration.
IMerge study is a two part study comprised of phase II and phase III stages of development for imetelstat for treating lower risk MDS in transfusion dependent patients.
Data from the phase II portion of the IMerge study showed that imetelstat has the potential to achieve meaningful and durable transfusion independence, as well as potential disease-modifying activity in MDS patients. Data presented in June demonstrated 8-week transfusion independence in 42% of patients and 24-week transfusion independence in 29% of patients. The median duration of transfusion independence was 85.9 weeks.
We remind investors that Geron had a collaboration with Janssen, a subsidiary of J&J JNJ, related to development of imetelstat, which was terminated by J&J last year. Geron now holds the full responsibility for development of imetelstat. Meanwhile, another MDS candidate, luspatercept, is being developed by Acceleron Pharma XLRN and its partner Celgene CELG in a phase III study, which may pose competition for imetelstat.
Apart from MDS, the company is also developing imetelstat for another hematologic myeloid malignancy, myelofibrosis (“MF”). In December 2018, Geron presented updated median overall survival (“OS”) data from the higher dosage arm (9.4 mg/kg) of the study. The candidate achieved median OS of 29.9 months, which suggests a meaningful survival outcome. The company is planning to conduct an end of phase II meeting with the FDA related to IMbark study in the first quarter of 2020 to discuss the path forward for the development of imetelstat in relapsed/refractory MF.
Last month, the FDA granted Fast Track designation to imetelstat for treating MF. The designation was given for treating adult patients with intermediate-2 or high-risk MF, whose disease has relapsed following treatment by a JAK inhibitor or is refractory to a JAK inhibitor, as well as patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera.
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Geron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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