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Geron Gets EMA COMP Positive Opinion For Imetelstat Orphan Drug Designation

Geron Corp. (GERN), a late-stage clinical biopharmaceutical company, said Wednesday that the European Medicines Agency or EMA Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the company's application for orphan drug designation of its first-in-class telomerase inhibitor, Imetelstat, as a potential treatment for myelodysplastic syndromes or MDS.

Geron said that based on the COMP positive opinion, it expects that the European Commission will formally grant the orphan drug designation for the European Union or EU by the end of July. The designation will provide a 10-year period of marketing exclusivity in the EU after product approval.

Imetelstat has already been granted orphan drug designation by the U.S. Food and Drug Administration as a potential treatment for MDS.

MDS is a group of blood disorders in which the proliferation of malignant progenitor cells produces multiple malignant cell clones in the bone marrow. This will result in disordered and ineffective production of the myeloid lineage, including red blood cells, white blood cells and platelets. Chronic anemia is the predominant clinical problem in patients who have lower risk MDS.

Geron also said that patients are currently enrolling in a company-sponsored Phase 3 clinical trial in lower risk MDS.

The IMerge Phase 3 clinical trial is a double-blind, randomized, placebo-controlled clinical trial with registration intent. The trial is designed to enroll about 170 patients with lower risk transfusion dependent MDS who are relapsed or refractory to an ESA, have not received prior treatment with either a hypomethylating agent or HMA, or lenalidomide, and who are non-del(5q).

Geron expects to complete patient enrollment by the end of the first quarter of 2021 and the top-line results to be available in the second half of 2022.

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