FDA asks Geron to Halt Development of Imetelstat
The FDA has placed it’s only pipeline candidate, imetelstat, on full clinical hold. The news sent shares of GERN plunging 61% on March 12, 2014. Geron had submitted an Investigation New Drug (IND) application for imetelstat, but the FDA issued a verbal notice halting the trials.
This will affect all of their ongoing studies, including phase 2 studies in essential thrombocythemia (ET), polycythemia vera (PV) and multiple myeloma. Geron had planned to conduct a phase 2 study in myelofibrosis scheduled to start in the first half of 2014, this study will most likely get delayed as well.
The FDA is concerned about the occurrence of low-grade liver function test, as well as the potential risk of chronic liver injury following long-term exposure to imetelstat. The full clinical hold is a major setback for the company. More details can be found here.