Geron Conducts End of Phase 2 Meeting for Imetelstat in Relapsed/Refractory Myelofibrosis
December 18 2019 - 4:30PM
Business Wire
Geron Corporation (Nasdaq: GERN) today announced that the
Company has conducted an End of Phase 2 meeting with the U.S. Food
and Drug Administration (FDA) to discuss the results of the IMbark
Phase 2 clinical trial of imetelstat in patients with
Intermediate-2 or High-risk myelofibrosis (MF) whose disease has
relapsed after or is refractory to janus kinase (JAK) inhibitor
treatment, or relapsed/refractory MF. Based on feedback from the
meeting, over the coming months Geron plans to submit several Phase
3 trial design proposals in relapsed/refractory MF and to have
further discussions with the FDA regarding potential regulatory
approval pathways. The Phase 3 trial proposals will be designed to
fully characterize the efficacy, safety, and benefit-risk profile
of imetelstat treatment for these patients, as well as to confirm
the clinical benefit and disease-modifying potential of imetelstat
in this indication. Subsequent to these additional discussions with
the FDA, and after considering the timing and resources required,
as well as other clinical development opportunities for imetelstat,
Geron will make a decision regarding potential late-stage
development of imetelstat in relapsed/refractory MF.
About Myelofibrosis
Myelofibrosis (MF), a type of myeloproliferative neoplasm, is a
chronic blood cancer in which abnormal or malignant precursor cells
in the bone marrow proliferate rapidly, causing scar tissue, or
fibrosis, to form. As a result, normal blood production in the bone
marrow is impaired and may shift to other organs, such as the
spleen and liver, which can cause them to enlarge substantially.
People with MF may have abnormally low or high numbers of
circulating red blood cells, white blood cells or platelets, and
abnormally high numbers of immature cells in the blood or bone
marrow. MF patients can also suffer from debilitating
constitutional symptoms, such as drenching night sweats, fatigue,
severe itching, or pruritus, abdominal pain, fever and bone pain.
The estimated prevalence of MF in the U.S. is approximately 13,000
patients, with an annual incidence of approximately 3,000 patients.
Up to 20% of patients with MF develop acute myeloid leukemia.
Approximately 70% of MF patients are classified as having
Intermediate 2 or High-risk disease, as defined by the Dynamic
International Prognostic Scoring System Plus, or DIPSS Plus,
described in a 2011 Journal of Clinical Oncology article. Today,
there are two drugs approved in Intermediate-2 or High-risk MF, and
both are JAK inhibitors. Currently, no drug therapy is specifically
approved for those patients who fail or no longer respond to that
treatment, and median survival for such MF patients is only
approximately 14 to 16 months, representing a significant unmet
medical need.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in hematologic
myeloid malignancies. Early clinical data suggest imetelstat may
have disease-modifying activity through the suppression of
malignant progenitor cell clone proliferation, which allows
potential recovery of normal hematopoiesis. Ongoing clinical
studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower
risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial
in Intermediate-2 or High-risk myelofibrosis (MF). 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. 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) Geron’s plans to submit several Phase
3 trial designs for relapsed/refractory MF and conduct additional
discussions with the FDA; (ii) that Geron’s Phase 3 clinical trial
proposals will be designed to fully characterize the efficacy,
safety, and benefit-risk profile of imetelstat treatment and
confirm the clinical benefit and disease-modifying potential of
imetelstat; (iii) that imetelstat may have disease-modifying
activity; 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 regulatory authorities permit
the further development of imetelstat for relapsed/refractory MF
before Geron’s submission of any Phase 3 clinical trial designs;
(ii) whether Geron decides not to submit any Phase 3 clinical trial
designs for relapsed/refractory MF to the FDA; (iii) whether Geron
is able to design several, or any, Phase 3 clinical trial designs
that the FDA agrees fully characterize the efficacy, safety, and
benefit-risk profile of imetelstat treatment and confirm the
clinical benefit and disease-modifying potential of imetelstat; and
(iv) imetelstat may not actually demonstrate disease-modifying
activity in clinical trials. 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, 2019. 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/20191218005735/en/
Suzanne Messere Investor and Media Relations investor@geron.com
media@geron.com CG Capital 877-889-1972
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