SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Geron Corp.
GERN 1.260+1.6%Oct 31 3:59 PM EST
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
From: Savant3/13/2014 4:44:57 PM
   of 3576
 
Geron receives verbal notice from the FDA that its IND application for imetelstat has been placed on full clinical hold
Co announces that the company has received verbal notice from FDA that its Investigational New Drug application for imetelstat has been placed on full clinical hold, affecting all ongoing company- sponsored clinical trials.
  • A full clinical hold is an order that the FDA issues to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial. The clinical hold affects the remaining eight patients in the company's Phase 2 study in essential thrombocythemia or polycythemia vera and the remaining two patients in the company's Phase 2 study in multiple myeloma.
  • In addition, the company's planned Phase 2 clinical trial in myelofibrosis will likely be delayed due to the clinical hold. It is possible that other studies using imetelstat, such as ongoing investigator-sponsored trials, may also be placed on clinical hold by the FDA.
  • Geron has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday afternoon, the FDA indicated that the clinical hold is due to the occurrence of persistent low-grade liver function test abnormalities observed in the Phase 2 study of imetelstat in ET/PV patients and the potential risk of chronic liver injury following long- term exposure to imetelstat.
  • The FDA expressed concern about whether these LFT abnormalities are reversible.
  • Geron plans to work diligently with the FDA to seek the release of the clinical hold.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News