Geron Corporation (NASDAQ:GERN) announced recently that the first patient has been dosed successfully in the expanded Part I of the IMerge Clinical trial of Imetelstat in the transfusion-dependent patients who have Low or Intermediate-1 risk myelodysplastic syndrome (MDS) and are resistant to the treatment of erythropoiesis-stimulating agent (ESA).
Imetelstat is a telomerase inhibitor that was first developed by Geron Corporation and entirely licensed to Janssen Biotech, Inc. globally. IMerge is developed in two parts: 32 patients were enrolled in Part 1 which is currently being expanded to add about 20 more patients who will be put on lenalidomide treatment to increase the experience in the target patient population.
The results from the first 32 patients have been revealed and accepted for presentation which was held at 59th Atlanta, Georgia in the second week of December. The accepted data has received support from the US Food and Drug Administration (FDA).
In 2014, Geron entered into an exclusive collaboration with Janssen Biotech, Inc., to develop and commercialize the imetelstat for treatment of patients with oncology including hematologic myeloid malignancies and other uses of human therapeutics usage. One of the terms of agreement include; Geron receiving an upfront payment of about $35 million and an additional payment of up to $900 million to cover the expenses of development, regulatory, and commercial milestones and royalties.
All the operating expenses including the regulatory, development, production and promotional activities of imetelstat are currently being handled by a joint governance structure with Janssen being directly involved in the management.
Geron focuses on the collaborative development of its imetelstat in hematologic myeloid malignancies. Imetelstat is a specific inhibitor of telomerase which is usually administered through intravenous infusion. The imetelstat compound was first discovered by Geron and has since designed and modified it in various clinical trials. The common side effects that have been reported in imetelstat clinical studies are fatigue, cytopenias, and gastrointestinal symptoms.