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Geron Corporation reports removal of partial clinical hold on Myelofibrosis IST


Thursday, 12 Jun 2014 05:00am EDT 

Geron Corporation:Says that U.S. Food and Drug Administration (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 2014 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, Ayalew Tefferi of Mayo Clinic, Rochester, Minnesota, 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, 2014, the FDA informed the investigator that it had completed the review of his complete response submission and concluded that the Myelofibrosis IST may proceed. 

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29 Aug 2014