Geron Corporation (Nasdaq:GERN) today announced that four abstracts
related to the telomerase inhibitor imetelstat have been accepted
for presentation at the 59th American Society of Hematology (ASH)
Annual Meeting and Exposition to be held in Atlanta, Georgia from
December 9-12, 2017. The abstracts were published today on the ASH
website at www.hematology.org.
Clinical Data Presentation
An abstract containing data from the first 32 patients enrolled
in Part 1 of IMerge, the ongoing Phase 2/3 clinical trial of
imetelstat in patients with lower risk myelodysplastic syndromes
(MDS) being conducted by Janssen Research & Development, LLC.,
was accepted for a poster presentation.
Title: Efficacy and Safety of Imetelstat in RBC
Transfusion-Dependent (TD) IPSS Low/Int-1 MDS Relapsed/Refractory
to Erythropoiesis-Stimulating Agents (ESA) (IMerge)
(Abstract #4256)Date: Monday, December 11, 2017Time: 6:00 p.m. –
8:00 p.m. ET
Pre-Clinical Data Presentations
Three abstracts by academic collaborators were selected for
presentation that build on previous studies investigating
imetelstat’s effects and mechanism of action in pre-clinical models
of hematologic myeloid malignancies.
Title: Imetelstat, a Telomerase Inhibitor, Is Capable of
Depleting Myelofibrosis Hematopoietic Stem Cells and Progenitor
Cells (Abstract #1654) Date: Saturday, December 9,
2017Time: 5:30 p.m. - 7:30 p.m. ET
Title: Telomerase Inhibition Impairs Self-Renewal of
b-Catenin Activated Myeloproliferative Neoplasm
Progenitors (Abstract #2860)Date: Sunday, December 10,
2017 Time: 6:00 p.m. – 8:00 p.m. ET
Title: Integrated Molecular Analysis Identifies
Replicative Stress as Sensitizer to Imetelstat Therapy in
AML (Abstract #798)Date: Monday, December 11, 2017 Time:
5:45 p.m. ET
In accordance with ASH policies, abstracts submitted to the ASH
Annual Meeting are embargoed from the time of submission. To be
eligible for presentation at the ASH Annual Meeting, any additional
data or information to be presented at the Annual Meeting may not
be made public before the presentation. The imetelstat posters and
slides will be available in the “R&D” section of Geron’s
website (www.geron.com) following the ASH Annual Meeting
presentations.
Webcast Investor Event
Following the clinical data presentation at the ASH Annual
Meeting, management will be hosting a live webcast of an analyst
and investor meeting on December 11, 2017 to discuss the imetelstat
clinical data in MDS presented. The audio and slide presentation
will be accessible at www.geron.com on the Investor Relations
pages, under Events. Following the live presentation, the webcast
will be archived and available for replay at the same address for a
period of 30 days.
About Imetelstat
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific
inhibitor of telomerase that is administered by intravenous
infusion. This first-in-class compound, discovered by Geron, is a
specially designed and modified short oligonucleotide, which
targets and binds directly with high affinity to the active site of
telomerase. Preliminary clinical data suggest imetelstat might have
disease-modifying activity by inhibiting the progenitor cells of
the malignant clones associated with hematologic malignancies in a
relatively select manner. Most commonly reported adverse events in
imetelstat clinical studies include fatigue, gastrointestinal
symptoms and cytopenias. Imetelstat has not been approved for
marketing by any regulatory authority.
About the Collaboration with Janssen
On November 13, 2014, Geron entered into an exclusive worldwide
license and collaboration agreement with Janssen Biotech, Inc., to
develop and commercialize imetelstat for oncology, including
hematologic myeloid malignancies, and all other human therapeutics
uses. Under the terms of the agreement, Geron received an upfront
payment of $35 million and is eligible to receive additional
payments up to a potential total of $900 million for the
achievement of development, regulatory and commercial milestones,
as well as royalties on worldwide net sales. All regulatory,
development, manufacturing and promotional activities related to
imetelstat are being managed through a joint governance structure,
with Janssen responsible for these activities.
About Geron
Geron is a clinical stage biopharmaceutical company focused on
the collaborative development 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 statements in this
press release regarding: (i) the ability of imetelstat to deplete
myelofibrosis hematopoietic stem cells and progenitor cells; (ii)
the safety and efficacy of imetelstat; (iii) potential receipt by
Geron of additional payments up to a potential total of $900
million for the achievement of development, regulatory and
commercial milestones, and royalties from sales of imetelstat; and
(iv) 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 Janssen decides to continue to conduct
IMerge; (ii) whether imetelstat is safe and efficacious and will
succeed in IMerge by overcoming all of the clinical safety and
efficacy, technical, scientific, manufacturing and regulatory
challenges; (iii) whether the FDA or other health authorities
permit IMerge to continue to proceed under the existing protocols
or any amendments thereto; (iv) the prospective ability of
imetelstat to deplete myelofibrosis hematopoietic stem cells and
progenitor cells may not result in imetelstat being sufficiently
efficacious to be approved for commercial use in any disease
indication; (v) Geron’s dependence on Janssen for the development,
regulatory approval, manufacture and commercialization of
imetelstat, including the risks that if Janssen were to breach or
terminate the collaboration agreement or otherwise fail to
successfully develop and commercialize imetelstat and in a timely
manner, or at all, Geron would not obtain the anticipated financial
and other benefits of the collaboration agreement with Janssen and
the clinical development or commercialization of imetelstat could
be delayed or terminated; (vi) whether any future efficacy or
safety results from any clinical trial of imetelstat may cause the
benefit/risk profile of imetelstat to become unacceptable; and
(vii) whether patent coverage of imetelstat enables Janssen to
successfully commercialize imetelstat. Additional information on
the above-stated 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, 2017. 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:
Anna Krassowska, Ph.D.Investor and Media
Relations650-473-7765investor@geron.com media@geron.com
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