Geron Announces U.S. Expanded Access Protocol for Imetelstat in Lower Risk MDS

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor. As allowed under the U.S. Food and Drug Administration (FDA) policies, companies may offer an EAP, which permits an investigational medicinal product intended to treat a serious or life-threatening condition, such as lower risk myelodysplastic syndromes (MDS), to be used outside of a clinical trial.1

“We have heard physicians in both academic and community settings express the need for new treatment options for their lower risk MDS patients, and they will now have an option to access imetelstat through the EAP,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “With positive IMerge Phase 3 results submitted to the FDA, we now plan to be working with clinicians, patients and the MDS patient advocacy community to provide access to imetelstat for eligible patients through our EAP that was accepted by the FDA.”

The imetelstat EAP is available for patients with transfusion dependent non-del(5q) lower risk MDS who are refractory to, relapsed after, or ineligible for erythropoiesis-stimulating agents (ESAs), and naïve to lenalidomide and hypomethylating agents (HMAs). Transfusion dependent is defined as requiring at least four units of packed red blood cells (RBCs) over any eight-week period during the 16 weeks prior to being considered for the EAP.

The Company recently announced the submission to the FDA of a New Drug Application (NDA) for imetelstat, which is based on results from the IMerge Phase 3 clinical trial. In that trial, the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. placebo (P