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, DATED MARCH 20, 2014 Geron Reports Myelofibrosis IST Placed on Partial Clinical Hold Patients Deriving Clinical Benefit May Continue Imetelstat Treatment Menlo Park, Calif.

Key Takeaway: PRESS RELEASE, DATED MARCH 20, 2014 Geron Reports Myelofibrosis IST Placed on Partial Clinical Hold Patients Deriving Clinical Benefit May Continue Imetelstat Treatment Menlo Park, Calif., March 20, 2014 Geron Corporation (Nasdaq: GERN) announced today that patients curren

Full Press Release Details

PRESS RELEASE, DATED MARCH 20, 2014
Geron Reports Myelofibrosis IST
Placed on Partial Clinical Hold
Patients Deriving Clinical Benefit
May Continue Imetelstat Treatment
Menlo Park, Calif., March 20,
2014 Geron Corporation (Nasdaq: GERN)
announced today that patients currently enrolled in the investigator-sponsored
clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST) who are
deriving clinical benefit may continue imetelstat treatment under a partial
clinical hold placed by the U.S. Food and Drug Administration (FDA). The
investigator of the Myelofibrosis IST is Dr. Ayalew Tefferi of Mayo Clinic,
Rochester, Minnesota.
The partial clinical hold means that no
new patients may be enrolled into the Myelofibrosis IST, and patients currently
enrolled must demonstrate that they are deriving clinical benefit in order to
continue taking imetelstat. Mayo Clinic informed Geron in January 2014 that the
Myelofibrosis IST had ceased enrolling new patients, and did not cite any safety
concerns as the basis for that decision. The investigator has agreed to provide
to the FDA specific criteria he will use to determine which patients will
continue imetelstat treatment in the Myelofibrosis IST.
In its written notification to the
investigator, the FDA cited the reason for the partial clinical hold was that a
safety signal of hepatotoxicity had been identified in clinical trials of
imetelstat, and that it is not known if this hepatotoxicity is reversible. In
order to resolve the partial clinical hold on the Myelofibrosis IST, the
investigator is required to provide to the FDA follow-up information regarding
reversibility of hepatotoxicity for all patients who received imetelstat in the
Myelofibrosis IST. For patients who did not experience any abnormality in liver
function tests (LFTs), LFT follow-up until 30 days from the last imetelstat dose
must be obtained. For patients who experienced any abnormality in LFTs,
follow-up LFTs must be obtained until resolution to baseline or normal range for
at least two consecutive determinations. Dr. Tefferi has informed Geron that he
plans to work diligently to seek release of the partial clinical hold.
As previously announced, Geron s
Investigational New Drug (IND) application related to imetelstat is currently on
full clinical hold following the FDA s review of data related to safety in the
company s then-ongoing clinical trials. A full clinical hold is an order that
the FDA issues to a trial sponsor to suspend all ongoing clinical trials and
delay all proposed trials under that IND. With the full clinical hold, the company has stopped
imetelstat treatment in a total of ten patients in the Geron-sponsored Phase 2
clinical trials of imetelstat in essential thrombocythemia or polycythemia vera
and in multiple myeloma.
Geron expects to provide an update
regarding its clinical hold during the company s first quarter conference call.
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.
Last updated: Mar 20, 2014