Geron Announces Opening of IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis
December 11 2020 - 8:30AM
Business Wire
Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today announced the opening for patient
screening and enrollment of the IMpactMF Phase 3 clinical trial of
imetelstat, a first-in-class telomerase inhibitor, in refractory
myelofibrosis (MF).
“As Geron’s second registration-enabling Phase 3 trial in
hematologic myeloid malignancies, the IMpactMF trial represents a
milestone for our Company,” said Aleksandra Rizo, M.D., Ph.D.,
Geron’s Chief Medical Officer. “The IMpactMF trial will evaluate
imetelstat in a poor-prognosis refractory MF patient population to
confirm the clinical benefits of extended overall survival and
symptom improvement observed in our IMbark Phase 2 trial, as well
as the reductions in abnormal clones and mutation burden
demonstrating disease-modifying activity of imetelstat.”
Geron plans for IMpactMF to evaluate imetelstat compared to best
available therapy (BAT) in approximately 320 patients with
Intermediate-2 or High-risk MF. Patients eligible for the trial
will be required to be non-responsive, or refractory, to treatment
with a JAK inhibitor. The primary efficacy endpoint for the Phase 3
trial is overall survival (OS). Secondary endpoints include symptom
response, spleen response, progression free survival, duration of
response, safety, pharmacokinetics and patient reported outcomes.
Geron plans to engage over 150 sites to participate in IMpactMF
across North America, South America, Europe and Asia, with the
majority of clinical sites expected to be open for screening and
enrollment in 2021, subject to potential delays or interruptions
associated with the evolving and uncertain effects of the COVID-19
pandemic.
To learn more about IMpactMF and whether the study is enrolling
patients in your area, please visit www.clinicaltrials.gov.
About Myelofibrosis (MF)
Myelofibrosis, a type of myeloproliferative neoplasm, is a
chronic blood cancer in which abnormal or malignant precursor cells
in the bone marrow proliferate rapidly, causing scar tissue, or
fibrosis, to form. People with MF may have abnormally low or high
numbers of circulating red blood cells, white blood cells or
platelets, and abnormally high numbers of immature cells in the
blood or bone marrow. MF patients can also suffer from debilitating
constitutional symptoms, such as drenching night sweats, fatigue,
severe itching, or pruritus, abdominal pain, fever and bone
pain.
Approximately 70% of MF patients are classified as having
Intermediate-2 or High-risk disease, as defined by the Dynamic
International Prognostic Scoring System Plus. There are more than
35,000 patients worldwide and more than 13,000 patients in the U.S.
living with Intermediate-2 or High-risk MF. The only drug therapies
approved for treating these MF patients are JAK inhibitors.
Currently, MF patients who fail or no longer respond to JAK
inhibitor treatment have no or limited options, resulting in
shortened median overall survival.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
myeloid malignancies. Phase 2 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. Geron is currently conducting two
registration-enabling Phase 3 clinical trials of imetelstat:
IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes
(MDS), and IMpactMF, a Phase 3 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 plans
to enroll approximately 320 patients and engage over 150 sites to
participate in IMpactMF, and expects the majority of such clinical
sites to be open for screening and enrollment in 2021; (ii) that
clinical data strongly suggest imetelstat has disease-modifying
activity; and (iii) 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 approximately 320 patients to be
enrolled and for over 150 medical centers globally to participate
in IMpactMF; (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 IMpactMF 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
maintains sufficient funding to complete IMpactMF; (vii) 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 (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 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/20201211005044/en/
Suzanne Messere Investor and Media Relations investor@geron.com
media@geron.com
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