Geron Announces First Patient Dosed in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes
October 10 2019 - 5:30PM
Geron Corporation (Nasdaq: GERN) today announced that the first
patient has been dosed in the IMerge Phase 3 clinical trial to
evaluate imetelstat, a first-in-class telomerase inhibitor, in
lower risk myelodysplastic syndromes (MDS).
“Patients with lower risk MDS become dependent on serial
transfusions which leads to iron overload, heart and kidney
complications, decreases in quality of life and shorter overall
survival. Reducing transfusion burden and achieving transfusion
independence remain significant medical needs for this disease,”
said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer.
“Dosing of the first patient in the IMerge Phase 3 clinical trial
is an important step in developing imetelstat as a potential
alternative for patients with lower risk MDS who have limited
treatment options available today.”
IMerge is a two-part Phase 2/3 clinical trial of imetelstat in
transfusion dependent patients with lower risk MDS who are relapsed
after or refractory to erythropoiesis-stimulating agents (ESAs).
The Phase 3 is planned to enroll approximately 170 patients in a
randomized, double-blind, placebo-controlled clinical trial to test
the hypothesis that imetelstat improves the rate of red blood cell
transfusion independence (TI). A target patient population of
non-del(5q) lower risk MDS patients who are naïve to treatment with
hypomethylating agents (HMAs) and lenalidomide was identified in
Part 1 of IMerge, or the Phase 2 portion, and will be enrolled in
the Phase 3. The trial is planned to be conducted at multiple
medical centers globally, including North America, Europe, Middle
East and Asia. The primary endpoint is 8-week TI rate, 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.
Recently reported Phase 2 data from Part 1 of IMerge suggested
meaningful and durable transfusion independence, as well as
potential disease-modifying activity and transfusion independence
across different MDS patient subgroups, potentially achievable with
imetelstat treatment. Many key aspects from Part 1 of IMerge remain
the same for the Phase 3, including the primary and secondary
endpoints, the dose and schedule of imetelstat administration, the
target patient population, and a majority of the participating
clinical sites.
Based upon current planning assumptions, Geron expects top-line
results for the IMerge Phase 3 clinical trial to be available by
mid-year 2022.
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.
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. Many patients develop chronic anemia, the predominant
clinical problem in lower risk MDS, and become dependent on red
blood cell transfusions. There are approximately 60,000 people
living with the disease in the United States.
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 trial is planned to enroll approximately 170 patients and
is planned to be conducted at multiple medical centers globally;
(ii) that Geron expects top-line results for the IMerge Phase 3
trial to be available by mid-year 2022; (iii) that imetelstat may
have disease-modifying activity; (iv) that imetelstat may be a
potential alternative for patients with lower risk MDS and may
potentially be commercialized; (v) 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; and (vi) 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
Geron 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 and for multiple medical centers globally to
participate in the IMerge Phase 3 clinical trial 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 Geron will be able to successfully retain
and recruit key personnel to support its development plans; (vi)
whether imetelstat actually demonstrates disease-modifying activity
in patients; (vii) whether Geron 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 IMerge Phase 3 top-line results by mid-year
2022; and (viii) 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 June 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.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
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