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Partial clinical hold lifted at Mayo Clinic trial

  • After reviewing his information on the reversibility of hepatotoxicity, the FDA notifies the Mayo Clinic's Dr. Ayalew Tefferi that the partial clinical hold it placed in March on his investigator-sponsored clinical trial of Geron's (GERN) imetelstat as a treatment for myelofibrosis has been lifted. The hold was partial because patients who were deriving a clinical benefit from imetelstat continued receiving treatment. The clinic stopped enrolling new patients in January but it did not cite safety concerns as a basis for its decision.
  • Geron's IND for imetelstat remains on full clinical hold. This affects its clinical trials in essential thrombocythemia or polycythemia and in multiple myeloma. The company cannot submit any new clinical trial protocols until the hold is lifted. It is working diligently to rectify the situation.
  • Shares are up 34% premarket on higher than normal volume.
Comments (4)
  • gmmpa
    , contributor
    Comments (542) | Send Message
     
    I added to my GERN position after it cashed and burned when the hold was placed. Hopefully I was not wrong. Here we go again...
    12 Jun 2014, 08:43 AM Reply Like
  • John Motyka
    , contributor
    Comments (69) | Send Message
     
    Pa: Be nimble. GERN is a heartbreaker. I am still underwater, but continue to HOLD...jdm
    12 Jun 2014, 11:38 AM Reply Like
  • Charles FugittSR
    , contributor
    Comments (2) | Send Message
     
    Stay geron well make you money and save your life
    12 Jun 2014, 06:52 PM Reply Like
  • joegate
    , contributor
    Comments (2) | Send Message
     
    stay long this drug may be the only thing Geron needs the potential here is big. I think we will see $5 again soon
    14 Jun 2014, 06:15 PM Reply Like
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