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June 12, 2014
05:56 EDTGERNGeron says FDA removes partial clinical hold on imetelstat trial
Geron announced that the FDA has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis. The partial clinical hold was placed in March due to a safety signal of hepatotoxicity that was identified in clinical trials of imetelstat. In order to resolve the partial clinical hold, the investigator, Dr. Ayalew Tefferi of Mayo Clinic, was required to provide follow-up information regarding reversibility of hepatotoxicity for all patients who received imetelstat in the Myelofibrosis IST. In its letter dated June 11, the FDA informed the investigator that it had completed the review of his complete response submission and concluded that the Myelofibrosis IST may proceed. As previously announced, the Myelofibrosis IST ceased enrolling new patients in January, and Mayo Clinic did not cite any safety concerns as the basis for that decision. Previously enrolled patients who are deriving clinical benefit continue to receive treatment with imetelstat. Geron's Investigational New Drug application for imetelstat remains on full clinical hold affecting the company's clinical trials in essential thrombocythemia or polycythemia vera and in multiple myeloma. Until the FDA lifts the full clinical hold on Geron's IND, the company is unable to submit any new clinical trial protocols to the FDA under the company's IND for imetelstat and is unable to initiate any new clinical trials for imetelstat in the United States. The company said it is :working diligently to seek release of the full clinical hold."
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