Geron Announces First Patient Dosed in IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis
April 13 2021 - 7:30AM
Business Wire
Geron Corporation (Nasdaq: GERN) today announced that the first
patient has been dosed in IMpactMF, the Phase 3 clinical trial
evaluating imetelstat, a first-in-class telomerase inhibitor, in
refractory myelofibrosis (MF).
“As the only study in refractory MF with overall survival as the
primary endpoint, dosing of the first patient in IMpactMF is an
important step in developing imetelstat as a potential treatment
for these patients,” said Aleksandra Rizo, M.D., Ph.D., Geron’s
Chief Medical Officer. “With a median overall survival of only
approximately 14 – 16 months for patients who fail or no longer
respond to JAK inhibitor treatment, there is a significant unmet
medical need for therapies that will improve survival.”
IMpactMF is an open label, randomized, controlled Phase 3
clinical trial with registrational intent. The trial is designed to
enroll approximately 320 patients with Intermediate-2 or High-risk
myelofibrosis who are refractory to prior treatment with a JAK
inhibitor, also referred to as refractory MF. Patients will be
randomized to receive either imetelstat or best available therapy.
The primary endpoint is overall survival (OS). Key secondary
endpoints include symptom response, spleen response, progression
free survival, complete response, partial response, clinical
improvement, duration of response, safety, pharmacokinetics, and
patient reported outcomes.
The final analysis for OS is planned to be conducted after more
than 50% of the patients planned to be enrolled in the trial have
died (referred to as an event). An interim analysis of OS is
planned to be conducted after approximately 70% of the total
projected number of events for the final analysis have occurred.
Under current planning assumptions, the Company expects the interim
analysis for IMpactMF to occur in 2024 and the final analysis in
2025. Because these analyses are event-driven, the results may be
available at different times than currently expected.
IMpactMF is currently enrolling patients. The Company plans to
engage over 180 sites to participate in IMpactMF across North
America, South America, Europe, Australia and Asia. For further
information about IMpactMF, including enrollment criteria,
locations and current status, visit
ClinicalTrials.gov/NCT04576156.
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) that imetelstat
has potential disease-modifying activity; (ii) that Geron plans to
engage over 180 sites for IMpactMF; (iii) that under current
planning assumptions for IMpactMF, Geron expects to conduct an
interim analysis in 2024 and a final analysis in 2025; (iv) that
the final analysis for OS is planned to be conducted after more
than 50% of the patients planned to be enrolled in the trial have
died (i.e., an event) and that an interim analysis of OS is planned
to be conducted after approximately 70% of the total projected
number of events for the final analysis have occurred; and (v)
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 in
order to meet the expected timelines and planned milestones in
(ii), (iii) and (iv) above; (c) whether regulatory authorities
permit the further development of imetelstat on a timely basis, or
at all, without any clinical holds; (d) whether any future efficacy
or safety results may cause the benefit-risk profile of imetelstat
to become unacceptable; (e) whether imetelstat actually
demonstrates disease-modifying activity in patients; (f) that Geron
will need to raise substantial capital in order to complete the
development and commercialization of imetelstat, including to meet
all of the expected timelines and planned milestones in (ii), (iii)
and (iv) above; (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 Geron is able to enroll IMpactMF at a
pace that would enable an interim analysis in 2024 and a final
analysis in 2025. 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 annual report on Form 10-K for the year
ended December 31, 2020 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/20210413005381/en/
Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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