Full Press Release Details
PRESS RELEASE, DATED JUNE 12, 2014
Geron Reports Removal of Partial
Clinical Hold on Myelofibrosis IST
Menlo Park, Calif., June 12,
2014 Geron Corporation (Nasdaq: 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.
As previously announced, the Myelofibrosis
IST ceased enrolling new patients in January 2014, and Mayo Clinic did not cite
any safety concerns as the basis for that decision. Previously enrolled patients
who are deriving clinical benefit continue to receive treatment with imetelstat.
Geron s Investigational New Drug (IND)
application for imetelstat remains on full clinical hold affecting the company s
clinical trials in essential thrombocythemia or polycythemia vera and in
multiple myeloma. Until the FDA lifts the full clinical hold on Geron s IND, the
company is unable to submit any new clinical trial protocols to the FDA under
the company s IND for imetelstat and is unable to initiate any new clinical
trials for imetelstat in the United States. The company is working diligently to
seek release of the full clinical hold.
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.
Investor and Media Relations