At Geron, we are committed to developing our first-in-class telomerase inhibitor, imetelstat, to improve and extend the lives of patients with myelodysplastic syndromes and myelofibrosis. Our current focus is to complete our ongoing clinical trials to demonstrate safety and efficacy in order to obtain regulatory approval and provide widespread availability of imetelstat.
Prior to regulatory approval by the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities, patients gain access to investigational treatments, such as imetelstat, by participating in clinical trials. Expanded access, also called compassionate use, enables some patients with serious or life-threatening diseases, who would not have otherwise met the enrollment criteria for the clinical trials in progress, to gain access to investigational treatments. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety, tolerability and effectiveness.
Currently, Geron does not offer an expanded access program, and does not accept expanded access requests. We believe that access to imetelstat should be limited to controlled clinical trials until such time as its safety, tolerability and effectiveness for a particular indication has been determined and confirmed by regulatory authorities. Patient access to imetelstat outside of a controlled clinical trial may interfere with the conduct of our ongoing and future clinical trials, and may also disrupt the progress of our development program, which would, in turn, delay access to many patients in need.
Accordingly, while clinical trials are ongoing, we believe participation in our clinical trials is the only safe and appropriate way to access imetelstat.
If you have questions about Geron’s expanded access policy, please contact Geron at firstname.lastname@example.org. Please expect a response within five business days.
Use the link provided for more information about Geron’s clinical trials.
In line with the 21st Century Cures Act, Geron may revise this policy at any time.