Geron Announces First Patient Dosed in Expanded Part 1 of IMerge Clinical Trial in Myelodysplastic Syndromes
November 20 2017 - 7:30AM
Geron Corporation (Nasdaq:GERN) today announced that the first
patient has been dosed in the expanded Part 1 of IMerge, the
ongoing Phase 2/3 clinical trial of imetelstat in transfusion
dependent patients with Low or Intermediate-1 risk myelodysplastic
syndromes (MDS) who are refractory or resistant to treatment with
an erythropoiesis stimulating agent (ESA). Imetelstat is a
telomerase inhibitor initially developed by Geron and exclusively
licensed to Janssen Biotech, Inc. (Janssen) on a worldwide basis.
IMerge is designed in two parts: Part 1 is a Phase 2,
open-label, single-arm trial, and Part 2 is designed to be a Phase
3, randomized, controlled trial. As previously announced, 32
patients were enrolled in Part 1 of IMerge, of which a subset of 13
patients had not received prior treatment with either a
hypomethylating agent (HMA) or lenalidomide and did not have a
del(5q) chromosomal abnormality. As of May 2017, the 13-patient
subset showed an increased durability and rate of red blood cell
(RBC) transfusion independence (TI) compared to the overall trial
population (≥8-week RBC-TI: 53.8% vs 34.4%).
Based on these data, Part 1 of IMerge is being expanded to
enroll approximately 20 additional patients who are non-del(5q) and
naïve to HMA and lenalidomide treatment to increase the experience
and confirm the benefit-risk profile of imetelstat in this refined
target patient population. For more information about IMerge,
please visit https://clinicaltrials.gov/ct2/show/NCT02598661.
Results for the original 32 patients in Part 1 of IMerge 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 accepted abstracts
are available on the ASH website at www.hematology.org. These data
also supported the Fast Track designation in lower risk MDS
recently granted to imetelstat by the United States Food and Drug
Administration (FDA).
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) continued conduct by Janssen of IMerge
and any future clinical trials of imetelstat; (ii) potential
outcomes of any data reviews conducted by Janssen for IMerge; (iii)
the safety and efficacy of imetelstat; (iv) that approximately 20
additional patients in IMerge will be sufficient for
decision-making; (v) 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 (vi) 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) Janssen’s ability to collect additional and more mature data
from current clinical trials of imetelstat; (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
September 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.commedia@geron.com
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