Janssen and Geron commence study of new myelodysplastic syndrome therapy

Janssen has partnered with Geron to commence a study of a potentially promising new treatment for myelodysplastic syndromes (MDS).

The clinical trial, known as the IMerge study, is being conducted by Janssen Research and Development and is the second study to be initiated under the terms of the exclusive worldwide imetelstat license and collaboration agreement between the two companies.

Its purpose will be to evaluate imetelstat in transfusion-dependent patients with low or intermediate risk MDS who have relapsed after or are refractory to prior treatment with an erythropoiesis-stimulating agent.

Part one of the trial is planned as a phase II open-label single-arm design to assess the efficacy and safety of imetelstat, with up to 30 patients expected to be enrolled. If results are positive, part two – a phase III double-blind randomised study – will commence, comparing the efficacy of imetelstat against placebo among around 170 patients.

The primary efficacy endpoint will be the rate of red blood cell transfusion-independence lasting at least eight weeks, with analysis planned to occur 12 months after the last patient is enrolled.

MDS is a blood disorder that causes a drop in the patient's number of healthy blood cells, primarily affecting people between the ages of 65 and 70.