Full Press Release Details
Presentations at American Society of Hematology Annual Meeting
Imetelstat Clinical Data
from Part 1 of IMerge in Myelodysplastic Syndromes to be Presented
November 1, 2017 -- 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,
Time: 6:00 p.m. 8:00 p.m. ET
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
Saturday, December 9, 2017
Time: 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,
Time: 6:00 p.m. 8:00 p.m. ET
Title: Integrated Molecular Analysis Identifies
Replicative Stress as Sensitizer to Imetelstat Therapy in AML
Date: Monday, December 11,
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.
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
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
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
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
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