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FDA places clinical hold on imetelstat trials for essential thrombocythemia, multiple myeloma
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Geron Corporation recently received verbal notice from the FDA that its Investigational New Drug application for imetelstat, a lipid-conjugated oligonucleotide inhibitor of human telomerase, has been placed on full clinical hold, hindering ongoing clinical trials.
A full clinical hold is an order that the FDA issues to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial.
The clinical hold affects the remaining eight patients in the company’s phase 2 study in essential thrombocythemia or polycythemia vera, as well as the remaining two patients in the company's phase 2 study in multiple myeloma.
Additionally, the company's planned phase 2 clinical trial in myelofibrosis likely will be delayed due to the clinical hold. It is possible that other studies using imetelstat, such as ongoing investigator-sponsored trials, also may be placed on clinical hold.
Geron has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication, the FDA indicated that the clinical hold is due to the occurrence of persistent low-grade liver function test abnormalities observed in the phase 2 study of imetelstat in essential thrombocythemia/polycythemia vera patients and the potential risk of chronic liver injury following long-term exposure to imetelstat. The FDA expressed concern about whether these liver function test abnormalities are reversible.
Geron officials said they plan to work with the FDA to seek the release of the clinical hold.