Geron Reports Two Presentations at Virtual European Hematology Association Annual Congress
June 14 2021 - 4:30PM
Business Wire
Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today announced that two poster
presentations of new clinical data and analyses related to
imetelstat, the Company’s first-in-class telomerase inhibitor, are
now available on Geron’s website as well as to participants of the
EHA2021 Virtual Congress.
“These poster presentations further support imetelstat’s
differentiated approach to potentially target the malignant stem
and progenitor cells in the bone marrow by inhibiting telomerase
activity,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical
Officer. “Through this novel mechanism of action, imetelstat has
the potential to alter the course of MDS and MF which distinguishes
it from other treatments currently approved or in development. We
look forward to confirming these results in our ongoing Phase 3
clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in
refractory MF.”
Title: Efficacy of Imetelstat is Independent of Molecular
Subtypes in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS)
Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents
(ESA) Poster Code: EP910
New data and analyses were presented on the clinical efficacy of
imetelstat in molecularly defined subtypes based on cytogenetic and
mutation profiles for patients in the IMerge Phase 2 clinical
trial. As reported at previous EHA meetings, meaningful and durable
transfusion independence were observed in patients from IMerge
Phase 2, including transfusion-free periods greater than one year,
as well as substantial increases in hemoglobin. The current
presentation reported clinical responses across different
cytogenetic and molecularly defined categories whereby responses
were independent of mutation status or number of mutations. These
data support the unique telomerase inhibition mechanism of action
of imetelstat and the potential to target the malignant stem and
progenitor cells of the underlying disease.
Title: Imetelstat Demonstrates an Acceptable Safety Profile
in Myeloid Malignancies Poster Code: EP1106
Safety data from the Phase 2 IMbark and IMerge trials were
further analyzed to understand the characteristics of hematologic
and non-hematologic adverse events. These analyses highlighted that
the imetelstat-related cytopenias are short, reversable and with
limited clinical consequence when managed with the dose
modification guidelines in the protocols. These data are further
evidence for the on-target effect of imetelstat based on the
selective reduction of malignant cells in the bone marrow through
telomerase inhibition resulting in the observed meaningful clinical
benefits for patients in the Phase 2 trials.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
myeloid 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 hematologic myeloid 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 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. 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) imetelstat’s
potential to alter the course of MDS and MF; (ii) that imetelstat
has potential disease-modifying activity; (iii) the potential of
imetelstat to target the malignant stem and progenitor cells of the
underlying disease; and (iv) 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
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 to complete its two Phase 3
clinical trials; (b) whether regulatory authorities permit the
further development of imetelstat on a timely basis, or at all,
without any clinical holds; (c) whether any future efficacy or
safety results may cause the benefit-risk profile of imetelstat to
become unacceptable; (d) whether imetelstat actually demonstrates
disease-modifying activity in patients; and (e) whether imetelstat
demonstrates that it targets the malignant stem and progenitor
cells of the underlying disease in patients. 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 March 31, 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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version on businesswire.com: https://www.businesswire.com/news/home/20210614005513/en/
Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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