Full Press Release Details
Geron Announces IND Clinical Hold
Affecting Clinical Trials of Imetelstat in Essential
Conference Call Today, March 12, at
Menlo Park, Calif., March 12, 2014
Geron Corporation (Nasdaq: GERN)
announced today that the company has received verbal notice from the U.S. Food
and Drug Administration (FDA) that its Investigational New Drug (IND)
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
The clinical hold affects the remaining
eight patients in the company s Phase 2 study in essential thrombocythemia (ET) or
polycythemia vera (PV) 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
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 (LFT) 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
This afternoon s previously scheduled
conference call to discuss the fourth quarter and annual 2013 financial results
is cancelled. These results will be reported in the company s Annual Report on
Geron s management will host a conference
call at 8:30 a.m. EDT to discuss the clinical hold. Participants can access the
conference call live via telephone by dialing 866-700-6293 (U.S.); 617-213-8835
(international). The passcode is 52642998. A live audio-only webcast is also
available at http://www.media-server.com/m/p/4rmnjn2s. The audio webcast of the
conference call will be available for replay approximately one hour following
the live broadcast through April 12, 2014.
Geron is a clinical stage
biopharmaceutical company developing a first-in-class telomerase inhibitor,
imetelstat, in hematologic myeloid malignancies. For more information about
Geron, visit www.geron.com.
Anna Krassowska, Ph.D.