Full Press Release Details
Press Release, Dated
Geron Announces Completion of Second
Internal Data Reviews for Imetelstat Trials Being Conducted by Janssen
Both IMerge and IMbark Continue in
Lower Risk Myelodysplastic Syndromes and Relapsed or Refractory
Conference Call Scheduled for 8:00
a.m. EDT Today, April 10
MENLO PARK, Calif., April 10, 2017
-- Geron Corporation (Nasdaq: GERN) today
announced that Janssen Research & Development, LLC has completed the second
internal data reviews of IMerge and IMbark, the clinical trials of the
telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS)
and relapsed or refractory myelofibrosis (MF), respectively. For IMerge, the
benefit/risk profile of imetelstat in the treated patients supports continued
development in lower risk myelodysplastic syndromes. A data package and proposed
trial design refinements are planned to be provided to the FDA. For IMbark, the
current results suggest clinical benefit and a potential overall survival
benefit associated with imetelstat treatment in relapsed or refractory
myelofibrosis; the trial will continue unchanged to evaluate maturing efficacy
and safety data, including an assessment of overall survival.
IMerge (NCT02598661) is a Phase 2/3
clinical trial evaluating imetelstat in transfusion dependent patients with Low
or Intermediate-1 risk 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 designed to be a Phase 3, randomized,
controlled trial in approximately 170 patients. The primary efficacy endpoint is
the rate of red blood cell transfusion independence lasting at least 8 weeks.
Key secondary endpoints include the rates of red blood cell transfusion
independence lasting at least 24 weeks and hematologic improvement. Part 1 of
the trial is fully enrolled.
The second internal review of IMerge
included data from the approximately 30 patients enrolled in Part 1. Based on
this second internal review, the Collaboration s Joint Steering Committee has
determined the following:
| The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. | |
| The benefit/risk profile of imetelstat, including assessments of 8-week and 24-week transfusion independence and hematologic improvement by erythroid (HI-E) response, across multiple MDS subtypes, supports continued development in lower risk MDS. | |
| Part 1 of the trial will continue unmodified, and patients remaining in the treatment phase may continue to receive imetelstat. | |
| A data package, as well as proposed refinements to the trial design for Part 2 of IMerge, is planned to be provided to the FDA. | |
| Data from Part 1 are expected to be submitted for consideration for presentation at a medical conference in the future. |
Geron expects that FDA feedback and the
totality of imetelstat program information, including an assessment of the
evolving treatment landscape in MDS and the potential application of imetelstat
in multiple hematologic malignancies, will inform Janssen s decision to initiate
Part 2 of IMerge. If Part 2 of IMerge is initiated, Geron expects this Phase 3 stage
of IMerge to be opened for patient enrollment in the fourth quarter of 2017.
IMbark (NCT02426086) was 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
with Intermediate-2 or High risk 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 ( 35% reduction in spleen volume assessed by imaging)
and symptom response rate ( 50% reduction in Total Symptom Score) at 24 weeks.
The second internal review of IMbark
included data from the approximately 100 patients who were enrolled in the
trial, with each dosing arm analyzed separately. Based on this second internal
review, the Collaboration s Joint Steering Committee has determined the
| The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. | |
| The data support 9.4 mg/kg as an appropriate starting dose for the relapsed or refractory MF patient population. | |
| In these relapsed or refractory MF patients treated in the 9.4 mg/kg dosing arm, the spleen volume response rate observed to date was less than that reported in front-line MF patients treated in trials with other drugs. However, activity within multiple outcome measures was observed with imetelstat treatment, which suggests clinical benefit in this relapsed or refractory MF patient population. These outcome measures included a range of spleen volume reductions, decreases in Total Symptoms Score, and improvements in hematologic parameters, such as anemia and peripheral blood counts. In addition, the data suggest a potential overall survival benefit associated with imetelstat treatment in these patients. | |
| The trial will continue without any modifications, including conduct of all safety and efficacy assessments as planned in the protocol, including overall survival. Patients remaining in the treatment phase may continue to receive imetelstat. | |
| Enrollment of new patients to the trial will remain suspended because the total number of patients enrolled to date is adequate to assess longer-term outcome measures when the data are fully matured. |
During the next year, Geron expects Janssen to
evaluate maturing efficacy and safety data from the trial, including an
assessment of overall survival. Geron expects the longer-term data from the trial,
potential health authority feedback, and the totality of imetelstat program
information, including an assessment of the evolving treatment landscape in MF
and the potential application of imetelstat in multiple hematologic
malignancies, including MDS, will inform Janssen s decision whether to continue
development of imetelstat in relapsed or refractory MF.
At 8:00 a.m. EDT on April 10, 2017,
Geron s management will host a conference call to review outcomes from the
second internal data reviews of IMbark and IMerge. Participants can access the
conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195
(international). The conference ID number is 6116409. A live audio-only webcast
is also available through the company s website at www.geron.com in the
Investors section under Events and at http://edge.media-server.com/m/p/w5mtfw9k.
The audio webcast of the conference call will be available for replay
approximately one hour following the live broadcast through May 11, 2017.
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.
Imetelstat has not been approved for marketing by any regulatory authority.
About the Collaboration with Janssen
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. The joint governance structure includes a Joint Steering
Committee with equal membership from both companies.
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.
Use of 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