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Genron - Partial Clinical hold lifted in 3 months

  1. interestingtome

    1,847 Posts.
    1
    Geron Corp. June 12, 2014 5:01 AM GlobeNewswire Europe


    Menlo Park, Calif., June 12, 2014 - Geron Corporation (GERN) announced today that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). 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, Dr. 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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