Geron Announces Two Presentations at Upcoming European Hematology Association Annual Congress
May 12 2021 - 10:56AM
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, will
be made at the European Hematology Association (EHA) Annual
Congress meeting to be held virtually from June 9 - 17. The
abstracts for the posters are available on the EHA website at
www.ehaweb.org. Both posters will be published on the EHA Virtual
Congress platform on June 11, 2021.
“We are pleased that the EHA accepted both of our abstracts
which allows us to present what we believe to be imetelstat’s
compelling potential to become a leading treatment for lower risk
MDS and MF patients,” said Aleksandra Rizo, M.D., Ph.D., Geron’s
Chief Medical Officer. “The new data and analyses from our Phase 2
IMbark and IMerge trials continue to highlight imetelstat’s
disease-modifying activity and potential to achieve remarkable
clinical benefits, including durable transfusion independence in
lower risk MDS patients and improvement in MF patients’ overall
survival. We look forward to the presentations and remain confident
that imetelstat, with its unique telomerase inhibition mechanism of
action, is a highly differentiated treatment that can positively
impact patients.”
Abstract 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) Abstract Code: EP910
The abstract reports new data and analyses of the clinical
efficacy of imetelstat in molecularly defined patient subtypes from
the IMerge Phase 2 clinical trial in transfusion dependent,
non-del(5q) lower risk myelodysplastic syndromes (MDS) patients who
are relapsed or refractory to ESAs. Clinical responses were
analyzed across multiple molecularly defined subgroups based on
cytogenetic and mutation profiles. The abstract concluded that
imetelstat demonstrated clinical efficacy across different
molecularly defined subgroups, including patients with poor
prognosis.
Abstract Title: Imetelstat Demonstrates an Acceptable Safety
Profile in Myeloid Malignancies Abstract Code:
EP1106
The abstract describes new analyses of safety data from the
Phase 2 IMbark and IMerge trials to further characterize
hematologic and non-hematologic adverse events (AEs). Based on
these analyses, the abstract concluded that imetelstat-related
cytopenias observed in the trials were on-target effects based on
the selective reduction of malignant cells through telomerase
inhibition. Also, these cytopenias were of short duration,
reversible and with limited clinical consequences when managed with
the dose modification guidelines in the respective trial protocols.
The difference in toxicity profiles between the two trials could be
attributed to the different disease pathologies (proliferation vs.
dysplasia) of patients with myelofibrosis or myelodysplastic
syndromes.
In accordance with EHA policies, abstracts submitted to the EHA
Annual Congress are embargoed from the time of submission. To be
eligible for presentation at the EHA Annual Congress, any
additional data or information to be presented at the EHA Annual
Congress may not be made public before the posters are published.
The posters will be available on Geron’s website at
www.geron.com/r-d/publications after June 11, 2021.
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
compelling potential to become a leading treatment for lower risk
MDS and MF patients; (ii) imetelstat’s potential to achieve
remarkable clinical benefits, including durable transfusion
independence in lower risk MDS patients and improvement in MF
patients’ overall survival; (iii) that imetelstat has potential
disease-modifying activity; 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
the current or evolving effects of the COVID-19 pandemic and
resulting global economic and financial disruptions will materially
and adversely impact Geron’s business and business prospects, its
financial condition and the future of imetelstat; (b) 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; (c) whether regulatory authorities permit
the further development of imetelstat on a timely basis, or at all,
without any clinical holds; (d) whether imetelstat is demonstrated
to be safe and efficacious in the IMerge Phase 3 and IMpactMF
clinical trials to enable regulatory approval; (e) whether any
future efficacy or safety results may cause the benefit-risk
profile of imetelstat to become unacceptable; (f) whether
imetelstat actually demonstrates disease-modifying activity in
patients; (g) whether there are failures or delays in manufacturing
or supplying sufficient quantities of imetelstat or other clinical
trial materials in a timely manner, whether due to the current or
evolving effects of the COVID-19 pandemic or otherwise; and (h)
whether imetelstat is able to maintain patent protection and have
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 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/20210512005694/en/
Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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