Geron Starts Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes
August 08 2019 - 08:08AM
Geron Corporation (Nasdaq: GERN) today announced the opening of
patient screening and enrollment for the Phase 3 portion of IMerge
to evaluate imetelstat, a first-in-class telomerase inhibitor, in
lower risk myelodysplastic syndromes (MDS).
“The start of the Phase 3 portion of IMerge is a significant
milestone for Geron and imetelstat,” said John A. Scarlett, M.D.,
Chairman and Chief Executive Officer. “We are hopeful that the
Phase 3 will confirm the encouraging results from the Phase 2
portion, and that imetelstat could become a much-needed treatment
alternative for patients with lower risk MDS.”
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 erythroid stimulating agents (ESAs). The
Phase 3 portion 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). The trial is planned to be
conducted at multiple medical centers globally, including North
America, Europe, Middle East and Asia. The primary efficacy
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.
Many key aspects from the Phase 2 portion of IMerge remain the
same for the Phase 3 portion. 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 from
the Phase 2 portion, and will be enrolled in the Phase 3. In
addition, the primary and secondary endpoints, the dose and
schedule of imetelstat administration and many of the clinical
sites remain the same as in the Phase 2. Recently reported Phase 2
data highlighted the meaningful and durable transfusion
independence, disease-modifying activity, and efficacy responses
across MDS patient subgroups potentially achievable with imetelstat
treatment.
Based upon current planning assumptions, Geron expects top-line
results for the IMerge Phase 3 trial to be available by mid-year
2022.
To learn more about IMerge 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. Imetelstat has been
granted Fast Track designation by the United States Food and Drug
Administration for the treatment of patients with transfusion
dependent anemia due to non-del(5q) lower risk MDS who are
refractory or resistant to an erythroid stimulating agent.
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 Phase 3
portion of IMerge 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 potentially be commercialized; (v) that the Company
is hopeful that the Phase 3 IMerge results will confirm the
encouraging results from the Phase 2; (vi) that recently reported
Phase 2 IMerge data highlighted the meaningful and durable
transfusion independence, disease-modifying activity, and efficacy
responses across MDS patient subgroups potentially achievable with
imetelstat treatment; and (vii) 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 and for multiple medical centers globally to
participate in the Phase 3 portion of IMerge 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 Phase 3 IMerge 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 the Company 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 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 Phase 3 IMerge 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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