Geron Announces Fifty Percent Enrollment Milestone in IMerge Phase 3 Clinical Trial in Lower Risk MDS
11 December 2020 - 12:30AM
Business Wire
IMerge Phase 3 enrollment completion expected
in second quarter of 2021
Top-line results expected in second half of
2022
Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today announced achievement of fifty
percent enrollment in the IMerge Phase 3 clinical trial of
imetelstat in lower risk myelodysplastic syndromes (MDS). Data from
the IMerge Phase 2 were recently presented at the American Society
of Hematology Annual Meeting and support the ongoing Phase 3.
“Reaching fifty percent enrollment is a key milestone towards
the completion of this registration-enabling Phase 3 clinical
trial, and we appreciate all of the support from our investigators
and the patients who are participating in this study,” said
Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “We
believe that the IMerge Phase 3 will confirm the meaningful and
durable transfusion independence and the disease-modifying activity
of imetelstat observed from the Phase 2, and that imetelstat could
become a much-needed treatment alternative for patients with lower
risk MDS.”
The IMerge Phase 3 is a double-blind, randomized,
placebo-controlled clinical trial with registration intent. The
trial is designed to enroll approximately 170 transfusion dependent
patients with Low or Intermediate-1 risk MDS, or 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
a consecutive period of eight weeks or longer, or 8-week RBC-TI
rate. Key secondary endpoints include the rate of RBC-TI of at
least 24 weeks, or 24-week RBC-TI rate, 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, and duration of transfusion
independence.
The Company continues to expect full enrollment in the IMerge
Phase 3 in the second quarter of 2021. As long as enrollment is
completed by the end of the first half of 2021, Geron maintains its
projection of top-line results from IMerge to be available in the
second half of 2022.
To learn more about IMerge and whether the study is enrolling
patients in your area, please visit www.clinicaltrials.gov.
About Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes is a group of blood disorders in which
the proliferation of malignant progenitor cells produces multiple
malignant cell clones in the bone marrow resulting in disordered
and ineffective blood production. There are approximately 60,000
people in the United States living with the disease and
approximately 16,000 reported new cases of MDS in the United States
every year. The majority of patients, approximately 70%, fall into
the lower risk groups at diagnosis, according to the International
Prognostic Scoring System that takes into account the presence of a
number of disease factors, such as cytopenias and cytogenetics, to
assign relative risk of progression to acute myeloid leukemia (AML)
and overall survival.
Chronic anemia is the predominant clinical problem in patients
who have lower risk MDS. Due to low hemoglobin, many of these
patients become dependent on red blood cell transfusions which can
lead to iron overload, higher risk of development AML and poorer
overall survival. Currently, no drug therapy has been shown
prospectively to alter or delay disease progression.
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 strongly suggest that
imetelstat has disease-modifying activity through the apoptosis of
malignant stem and progenitor cells, which allows potential
recovery of normal hematopoiesis. Current clinical studies of
imetelstat include IMerge, an ongoing Phase 2/3 trial in lower risk
myelodysplastic syndromes (MDS), and IMpactMF, an upcoming Phase 3
clinical trial in refractory 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 Geron
expects enrollment completion in the IMerge Phase 3 trial in the
second quarter of 2021 and that top-line results for the IMerge
Phase 3 trial to be available in the second half of 2022, as long
as enrollment is completed by the end of the first half of 2021;
(ii) that the IMerge Phase 3 trial will confirm the meaningful and
durable transfusion independence and disease-modifying activity of
imetelstat observed in the Phase 2; (iii) that clinical data
strongly suggest that imetelstat has disease-modifying activity;
(iv) that imetelstat may potentially be commercialized and become a
treatment alternative for patients with lower risk MDS; and (v)
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 the Company is able to overcome all the
clinical, safety, efficacy, operational, technical, scientific,
intellectual property, manufacturing and regulatory challenges to
enable: (a) 170 patients to be enrolled in the IMerge Phase 3 and
(b) the eventual commercialization of imetelstat; (ii) whether
regulatory authorities permit the further development and
commercialization of imetelstat on a timely basis, or at all,
without any clinical holds; (iii) whether imetelstat is
demonstrated to be safe and efficacious in the IMerge Phase 3
clinical trial and other clinical trials; (iv) whether any future
efficacy or safety results may cause the benefit-risk profile of
imetelstat to become unacceptable; (v) whether imetelstat actually
demonstrates disease-modifying activity in patients; (vi) whether
the Company is able to complete full study enrollment, sufficient
treatment and follow-up of patients to assess the primary and
secondary endpoints, and conduct necessary analyses to evaluate the
benefit-risk profile of imetelstat in lower risk MDS to reach
top-line results in the second half of 2022; (vii) whether the
Company has sufficient funding to commercialize imetelstat; (viii)
whether Geron overcomes all the potential delays, added expense and
other adverse impacts caused by the continuing and evolving effects
of the novel coronavirus (COVID-19) pandemic; and (ix) 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, 2020. 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/20201210005269/en/
Suzanne Messere Investor and Media Relations investor@geron.com
media@geron.com
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