Geron Announces Completion of Patient Enrollment in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes
October 18 2021 - 7:30AM
Business Wire
Top-Line Results Expected at the Beginning of
January 2023
Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical
company focused on the development and commercialization of
treatments for hematologic malignancies, today announced the
completion of patient enrollment in the IMerge Phase 3 clinical
trial to evaluate imetelstat, a first-in-class telomerase
inhibitor, in lower risk myelodysplastic syndromes (MDS). Based
upon current planning assumptions, Geron expects top-line results
for IMerge Phase 3 to be available at the beginning of January
2023.
“Completing patient enrollment in IMerge Phase 3 brings us one
step closer to delivering imetelstat as a potential treatment
alternative for patients with lower risk MDS who are relapsed or
refractory to ESAs. Achieving durable transfusion independence
remains a significant medical need for these patients,” said
Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “I
would like to thank all of the patients and their families, the
investigators, clinical site staff, as well as our employees for
supporting the achievement of this important milestone.”
Patients from the IMerge Phase 2 clinical trial achieved durable
transfusion independence with imetelstat treatment, including
transfusion-free periods greater than one year, irrespective of the
disease subgroup, such as ringed sideroblast positive or ringed
sideroblast negative. Such durability provides significant and
meaningful clinical benefit to lower risk MDS patients given their
chronic anemia and the debilitating impact of serial blood
transfusions. In addition, depletion of cytogenetic abnormalities
and reductions in key driver mutations associated with lower risk
MDS were observed, and these results were also correlated with
transfusion independence. Based on the IMerge Phase 2 data, taken
together, the durability, molecular and cytogenetic data provide
strong evidence for disease-modifying activity of imetelstat, which
has the potential to differentiate it from other currently approved
and investigational treatments in lower risk MDS today.
About IMerge Phase 3
IMerge Phase 3 is a double-blind, randomized, placebo-controlled
Phase 3 clinical trial with registrational intent. The trial is
designed to enroll approximately 170 transfusion dependent patients
with Low or Intermediate-1 risk myelodysplastic syndromes (MDS),
also referred to as lower risk MDS, who have relapsed after or are
refractory to prior treatment with an erythropoiesis stimulating
agent (ESA). The primary endpoint is the rate of red blood cell
(RBC) transfusion independence (TI) for any consecutive period of
eight weeks or longer, or 8-week RBC-TI rate. Key secondary
endpoints include the rate of RBC-TI lasting at least 24 weeks, or
24-week RBC-TI rate, and the rate of hematologic
improvement-erythroid (HI-E), defined as a reduction of at least
four units of RBC transfusions over eight weeks compared with the
prior RBC transfusion burden.
For further information about IMerge Phase 3, visit
ClinicalTrials.gov/NCT02598661.
About Myelodysplastic Syndromes
Myelodysplastic syndromes are a group of diverse blood disorders
that develop because bone marrow cells do not mature into healthy
blood cells. There are approximately 60,000 people living with the
disease in the United States. Approximately 70% of MDS patients are
categorized in the lower risk groups at diagnosis, according to the
International Prognostic Scoring System that assigns relative risk
of progression to acute myelogenous leukemia and overall survival
by taking into account the presence of a number of disease factors,
such as cytopenias and cytogenetics. The predominant clinical
problem in lower risk MDS is chronic anemia, and many patients
become dependent on red blood cell transfusions which leads to iron
overload, heart and kidney complications, decreases in quality of
life and shorter overall survival.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in myeloid
hematologic malignancies. Data from Phase 2 clinical trials provide
strong evidence that imetelstat targets telomerase to inhibit the
uncontrolled proliferation of malignant stem and progenitor cells
in myeloid hematologic malignancies resulting in malignant cell
apoptosis and potential disease-modifying activity. 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 myelofibrosis whose disease has
relapsed after or is refractory to janus associated 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 myeloid
hematologic malignancies. The Company currently is conducting two
Phase 3 clinical trials: IMerge in lower risk myelodysplastic
syndromes and IMpactMF in refractory myelofibrosis. 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 Geron
expects top-line results for IMerge Phase 3 to be available at the
beginning of January 2023; (ii) that the durability, molecular and
cytogenetic data provide strong evidence for disease-modifying
activity of imetelstat which has the potential to differentiate it
from other currently approved and investigational treatments in
lower risk MDS today; (iii) that imetelstat has potential
disease-modifying activity in patients and to target the malignant
stem and progenitor cells of the underlying disease; (iv) that
imetelstat is a potential treatment alternative for patients with
lower risk MDS who are relapsed or refractory to ESAs; and (v)
other statements that are not historical facts, constitute
forward-looking statements. These forward-looking 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: (a) whether the current or evolving
effects of the COVID-19 pandemic and resulting global economic and
financial disruptions will materially and adversely impact Geron’s
business and business prospects, its financial condition and the
future of imetelstat; (b) whether Geron overcomes all of the
potential delays and other adverse impacts caused by the current or
evolving effects of the COVID-19 pandemic, and overcomes all the
enrollment, clinical, safety, efficacy, technical, scientific,
intellectual property, manufacturing and regulatory challenges in
order to meet the expected timeline in (i) above and commercialize
imetelstat; (c) whether regulatory authorities permit the further
development of imetelstat on a timely basis, or at all, without any
clinical holds; (d) whether imetelstat is demonstrated to be safe
and efficacious in IMerge Phase 3; (e) whether any future efficacy
or safety results may cause the benefit-risk profile of imetelstat
to become unacceptable; (f) whether imetelstat actually
demonstrates disease-modifying activity in patients and the ability
to target the malignant stem and progenitor cells of the underlying
disease; (g) whether regulatory authorities require an additional
clinical trial for approval even if IMerge Phase 3 meets its
primary endpoints; (h) that Geron may not have sufficient financial
resources to complete the IMerge Phase 3 clinical trial and
commercialize imetelstat; (i) that Geron may engage in additional
financing alternatives; and (j) whether there are failures or
delays in manufacturing or supplying sufficient quantities of
imetelstat or other clinical trial materials in a timely manner.
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 filings and periodic reports
filed with the Securities and Exchange Commission under the heading
“Risk Factors” and elsewhere in such filings and reports, including
Geron’s quarterly report on Form 10-Q for the quarter ended June
30, 2021 and future filings and reports by Geron. 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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Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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