Geron Reports Two Poster Presentations at American Society of Hematology Annual Meeting
December 10 2019 - 9:15AM
Business Wire
Geron Corporation (Nasdaq: GERN) today announced that two
posters related to imetelstat, the Company’s first-in-class
telomerase inhibitor, were presented at the 61st American Society
of Hematology (ASH) Annual Meeting and Exposition in Orlando,
Florida on December 8 and 9. Both posters are available on Geron’s
website at www.geron.com/r-d/publications.
Trials in Progress Poster Presentation
Title: IMerge: A Study to Evaluate Imetelstat (GRN163L) in
Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk
Myelodysplastic Syndromes (MDS) That Is Relapsed/Refractory to
Erythropoiesis-Stimulating Agent (ESA) Treatment (Abstract
#4248)
The poster described key aspects of the IMerge Phase 2/3
clinical trial, including: the trial design; patient eligibility
criteria; primary, secondary and exploratory endpoints; and the
status of the trial. The poster also included a summary of
previously presented data from the Phase 2 portion of the IMerge
trial.
IMerge is an ongoing global two-part Phase 2/3 clinical trial of
imetelstat in red blood cell (RBC) transfusion dependent patients
with Low or Intermediate-1 risk, or lower risk myelodysplastic
syndromes (MDS), who have relapsed after or are refractory to prior
treatment with an erythropoiesis stimulating agent (ESA). The
primary endpoint for the IMerge Phase 2/3 clinical trial is 8-week
RBC transfusion independence (TI), which is defined as the
proportion of patients achieving transfusion independence during
any consecutive eight weeks since entry into the trial. Key
secondary endpoints include the rate of transfusion independence
lasting at least 24 weeks, or 24-week TI rate, durability of
transfusion independence and the amount and relative change in
transfusions.
IMerge Phase 3 Trial Now
Enrolling
The IMerge Phase 3 is planned to enroll approximately 170
patients in a randomized, double-blind, placebo-controlled clinical
trial. The trial will enroll non-del(5q) lower risk MDS patients
who are naïve to treatment with hypomethylating agents (HMAs) and
lenalidomide. The primary and secondary endpoints remain the same
as the Phase 2 portion of the trial. Approximately 90 sites are
planned to participate in 12 countries across North America,
Europe, Middle East and Asia. Enrollment opened in August 2019, and
the first patient was dosed in October 2019.
To learn more about the IMerge Phase 3 clinical trial and
whether the study is enrolling patients in your area, please visit
www.clinicaltrials.gov (NCT02598661).
IMerge Phase 2 Data Summary
- Imetelstat treatment showed meaningful and durable transfusion
independence in 38 non-del(5q) lower risk MDS patients who were
naïve to HMAs and lenalidomide.
- 42% (16/38) of patients achieved ≥8-week RBC-TI
- 29% (11/38) of patients achieved ≥24-week RBC-TI
- Median duration of TI was 85.9 weeks (range: 8.0-140.9)
- 68% (26/38) of patients achieved HI-E, or improvement in red
blood cell count, as measured by either transfusion reduction or a
rise in hemoglobin:
- All 26 patients had a reduction of at least four RBC units over
eight weeks compared with prior transfusion burden
- 12 patients had a hemoglobin increase of at least 1.5 g/dL
lasting at least eight weeks
- Mean relative reduction in transfusion burden from baseline was
68%
- Transfusion independence was observed across different MDS
patient subgroups.
- Biomarker data suggested potential impact on malignant clone
and disease modification by imetelstat treatment.
- No new safety signals were identified. Reversible cytopenias
were the most frequent adverse events.
Non-Clinical Data Poster Presentation
Title: Combination Treatment with Imetelstat, a Telomerase
Inhibitor, and Ruxolitinib Depletes Myelofibrosis Hematopoietic
Stem Cells and Progenitor Cells (Abstract #2963)
This poster presentation described results from early,
nonclinical experiments on the potential effect of combining
imetelstat and ruxolitinib on malignant myelofibrosis (MF) cells.
The experiments explored the hypothesis that, due to different
mechanisms of action, a combination of imetelstat and ruxolitinib
might create a treatment regimen for MF that could be more
efficacious than using either drug alone in reducing both malignant
progenitor and stem cells. Ruxolitinib is a janus kinase (JAK)
inhibitor that inhibits proliferation of malignant progenitor cells
without eliminating malignant stem cells. Imetelstat is a
telomerase inhibitor that selectively depletes malignant progenitor
and stem cells.
In the experiments, the sequential treatment of ruxolitinib
followed by imetelstat had additive inhibitory activity resulting
in greater reductions in both malignant progenitor and stem cells
when compared to simultaneous treatment or either drug alone.
Furthermore, the sequential treatment regimen did not affect normal
hematopoietic progenitor and stem cells. As stated in the poster,
these non-clinical findings suggest that sequential treatment of
ruxolitinib followed by imetelstat represents a potentially
effective treatment that may eliminate both malignant MF progenitor
and stem cells.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
myeloid malignancies. Early clinical data suggest imetelstat may
have disease-modifying activity through the suppression of
malignant progenitor cell clone proliferation, which allows
potential recovery of normal hematopoiesis. Ongoing clinical
studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower
risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial
in Intermediate-2 or High-risk myelofibrosis (MF). Imetelstat has
been granted Fast Track designation by the United States Food and
Drug Administration for both the treatment of patients with
non-del(5q) lower risk MDS who are refractory or resistant to an
erythropoiesis-stimulating agent and for patients with
Intermediate-2 or High-risk MF whose disease has relapsed after or
is refractory to janus kinase (JAK) inhibitor treatment.
About Geron
Geron is a late-stage clinical biopharmaceutical company focused
on the development and potential commercialization 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
Reform Act of 1995. Investors are cautioned that such statements,
include, without limitation, those regarding: (i) that the IMerge
Phase 3 clinical trial is planned to enroll approximately 170
patients and is planned to be conducted at multiple medical centers
globally; (ii) that recently reported Phase 2 IMerge data suggested
meaningful and durable transfusion independence, potential
disease-modifying activity, and transfusion independence across
different MDS patient subgroups potentially achievable with
imetelstat treatment; (iii) that imetelstat may have
disease-modifying activity; and (iv) other statements that are not
historical facts, constitute forward looking statements. These
statements involve risks and uncertainties that can cause actual
results to differ materially from those in such forward-looking
statements. These risks and uncertainties, include, without
limitation, risks and uncertainties related to: (i) whether
regulatory authorities permit the further development of imetelstat
on a timely basis, or at all, without any clinical holds; (ii)
whether imetelstat is demonstrated to be safe and efficacious in
clinical trials; (iii) whether any future efficacy or safety
results may cause the benefit-risk profile of imetelstat to become
unacceptable; (iv) whether imetelstat actually demonstrates
disease-modifying activity in patients; and (v) whether imetelstat
has adequate patent protection and freedom to operate. Additional
information on the above risks and uncertainties and additional
risks, uncertainties and factors that could cause actual results to
differ materially from those in the forward-looking statements are
contained in Geron’s periodic reports filed with the Securities and
Exchange Commission under the heading “Risk Factors,” including
Geron’s quarterly report on Form 10-Q for the quarter ended
September 30, 2019. Undue reliance should not be placed on
forward-looking statements, which speak only as of the date they
are made, and the facts and assumptions underlying the
forward-looking statements may change. Except as required by law,
Geron disclaims any obligation to update these forward-looking
statements to reflect future information, events or
circumstances.
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version on businesswire.com: https://www.businesswire.com/news/home/20191210005642/en/
Suzanne Messere Investor and Media Relations investor@geron.com
media@geron.com
CG Capital 877-889-1972
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