Full Press Release Details
Press Release Dated September 12, 2016
Geron Provides Update on
Imetelstat Trials Being Conducted by Janssen
Call Scheduled for 8:00 a.m. EDT Today,
September 12, 2016 --
Geron Corporation (Nasdaq: GERN)
today provided updates on
being conducted by Janssen
Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned
internal reviews of initial data from both trials
have been completed by Janssen, and
both trials are continuing in order to evaluate additional and
originally designed as a Phase 2
clinical trial to evaluate two dose levels of imetelstat (either
4.7 mg/kg or 9.4 mg/kg administered every
three weeks) in approximately 200 patients (approximately 100 patients per dosing arm) with Intermediate-2 or High
risk myelofibrosis (MF) who
have relapsed after or are refractory to prior treatment with a JAK
inhibitor. The co-primary efficacy endpoints for
the trial are spleen response rate and symptom response
rate at 24 weeks. To date, over
90 patients have been enrolled in the
trial across both dosing
assessment of the appropriate dose
and schedule for relapsed or refractory MF patients in
conducted a planned internal interim
review of safety, efficacy and pharmacokinetic
data from 20 patients from
each dosing arm who have been followed on the trial for
at least 12 weeks. Based on this first internal
review at the early 12-week time point, the following has
been determined by Janssen:
| The safety profile was consistent with previous imetelstat clinical trials in hematologic myeloid malignancies. No new safety signals were identified. | |
| Activity in the 4.7 mg/kg dosing arm does not warrant further investigation of that dose and this arm will be closed to new patient enrollment. An amendment to the trial protocol is planned to allow eligible patients in this arm to increase their dose to 9.4 mg/kg per investigator discretion. | |
| In the 9.4 mg/kg dosing arm, even though at the week 12 data assessment an insufficient number of patients met the protocol defined interim criteria, this arm warrants further investigation because encouraging trends in the efficacy data were observed. Patients already enrolled in this arm may continue to receive imetelstat. New enrollment in this arm will be suspended while the trial continues in order to obtain additional and more mature data that includes a longer follow-up of patients at 24 weeks, consistent with the co-primary efficacy endpoints. The number of patients enrolled to date is expected to be sufficient to inform potential future development of this dose. | |
| Janssen plans to conduct an additional internal data review in the second quarter of 2017 to include a longer follow-up of patients at 24 weeks. Potential outcomes of the second internal review at the 24-week time point could include resuming enrollment in the 9.4 mg/kg dosing arm, with or without changes to the dosing regimen; adding a new dosing arm; or closing the trial. | |
| Any protocol amendments will be subject to review by health authorities around the world. |
IMergeTM (NCT02598661) is a Phase 2/3 clinical
trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes
(MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The
clinical trial is in two parts: Part 1 is a Phase 2, open-label, single-arm design in approximately 30 patients and Part 2
is a Phase 3, randomized, double-blind, placebo-controlled design in approximately 170 patients. The primary efficacy endpoint is the rate of red blood cell transfusion-independence lasting at least 8 weeks. Part 1 of the trial is fully
Janssen has conducted an
initial internal review of efficacy, safety and pharmacokinetic data from a
subset of patients from Part 1 of IMergeTM
and this review indicated that
emerging safety and efficacy in IMergeTM is consistent with data reported
from the pilot study conducted at Mayo Clinic in MDS patients. IMergeTM
will continue unmodified at this time.
Further assessment of data
from IMergeTM is expected
to occur in the second quarter of 2017 to include longer follow-up of all patients enrolled in Part 1. A decision
on whether to move forward to Part 2 of IMergeTM will be based on an assessment of the
benefit/risk profile of imetelstat in these patients. If Janssen decides to
move forward with Part 2, the Phase 3 clinical trial is
expected to be open for patient enrollment in mid-2017.
Janssen expects to submit data
from Part 1 of IMergeTM to
be considered for presentation at a medical conference in the
At 8:00 a.m. EDT on September 12, 2016, Geron s management will host
a conference call to review outcomes from the internal data reviews of IMbarkTM and IMergeTM.
Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195
(international). The passcode is 80522983. A live audio-only webcast is also available on the company s website at
www.geron.com under Events and at http://edge.media-server.com/m/p/edpy9b4b. The audio webcast of the conference call will
be available for replay approximately one hour following the live broadcast through October 13, 2016.
Imetelstat (GRN163L;
JNJ-63935937) is a potent and specific inhibitor of
telomerase that is administered by intravenous infusion. This
first-in-class compound, discovered by Geron, is a
specially designed and modified short oligonucleotide, which targets
and binds directly with high affinity to the active site of telomerase.
Preliminary clinical data suggest imetelstat has
disease-modifying activity by inhibiting the progenitor
cells of the malignant clones associated with hematologic malignancies in
a relatively select manner. Most commonly reported adverse events
in imetelstat clinical studies include fatigue, gastrointestinal symptoms and
cytopenias. Patients in these studies also experienced
elevated liver enzymes, which resolved to normal or baseline in the majority of
patients followed after imetelstat treatment was withdrawn.
Imetelstat has not been approved for marketing by any regulatory authority.
About the Collaboration
On November 13, 2014, Geron entered into an exclusive worldwide
license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology,
including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron
received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900
million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide
net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed
through a joint governance structure, with Janssen responsible for these activities.
Geron is a clinical stage
biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor,
imetelstat, in hematologic myeloid malignancies. For more information about
Geron, visit www.geron.com.
Forward-Looking Statements
Except for the historical information contained herein, this press release
contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) continued
conduct by Janssen of IMbarkTM or IMergeTM; (ii) Janssen obtaining additional or more mature data from
IMbarkTM or IMergeTM; (iii) that the number of patients enrolled in IMbarkTM to date is
sufficient to inform potential development of the 9.4 mg/kg dose; (iv) that Janssen will conduct any additional or further
data reviews in or protocol amendments for IMbarkTM or IMergeTM, and the timing of such data reviews
or protocol amendments; (v) potential outcomes of any data reviews conducted by Janssen; (vi) any future presentation of
data from current clinical trials of imetelstat by Janssen; (vii) the safety and efficacy of imetelstat; (viii) the
potential receipt by Geron of additional payments up to a potential total of $900 million for the achievement of
development, regulatory and commercial milestones, and royalties from sales of imetelstat; and (ix) other statements that