Geron Provides Update on Imetelstat Trials Being Conducted by Janssen
September 12 2016 - 7:30AM
Geron Corporation (Nasdaq:GERN) today provided updates on the
clinical trials being conducted by Janssen Research &
Development, LLC, of the telomerase inhibitor imetelstat. Planned
internal reviews of initial data from both trials have been
completed by Janssen, and both trials are continuing in order to
evaluate additional and more mature data.
IMbarkTM
IMbarkTM (NCT02426086) was originally designed as a Phase 2
clinical trial to evaluate two dose levels of imetelstat (either
4.7 mg/kg or 9.4 mg/kg administered every three weeks) in
approximately 200 patients (approximately 100 patients per dosing
arm) with Intermediate-2 or High risk myelofibrosis (MF) who have
relapsed after or are refractory to prior treatment with a JAK
inhibitor. The co-primary efficacy endpoints for the trial are
spleen response rate and symptom response rate at 24 weeks. To
date, over 90 patients have been enrolled in the trial across both
dosing arms.
To inform an assessment of the appropriate dose and schedule for
relapsed or refractory MF patients in IMbarkTM, Janssen conducted a
planned internal interim review of safety, efficacy and
pharmacokinetic data from 20 patients from each dosing arm who have
been followed on the trial for at least 12 weeks. Based on this
first internal review at the early 12-week time point, the
following has been determined by Janssen:
- The safety profile was consistent with previous imetelstat
clinical trials in hematologic myeloid malignancies. No new safety
signals were identified.
- Activity in the 4.7 mg/kg dosing arm does not warrant further
investigation of that dose and this arm will be closed to new
patient enrollment. An amendment to the trial protocol is planned
to allow eligible patients in this arm to increase their dose to
9.4 mg/kg per investigator discretion.
- In the 9.4 mg/kg dosing arm, even though at the week 12 data
assessment an insufficient number of patients met the protocol
defined interim criteria, this arm warrants further investigation
because encouraging trends in the efficacy data were observed.
Patients already enrolled in this arm may continue to receive
imetelstat. New enrollment in this arm will be suspended while the
trial continues in order to obtain additional and more mature data
that includes a longer follow-up of patients at 24 weeks,
consistent with the co-primary efficacy endpoints. The number of
patients enrolled to date is expected to be sufficient to inform
potential future development of this dose.
- Janssen plans to conduct an additional internal data review in
the second quarter of 2017 to include a longer follow-up of
patients at 24 weeks. Potential outcomes of the second internal
review at the 24-week time point could include resuming enrollment
in the 9.4 mg/kg dosing arm, with or without changes to the dosing
regimen; adding a new dosing arm; or closing the trial.
- Any protocol amendments will be subject to review by health
authorities around the world.
IMergeTM
IMergeTM (NCT02598661) is a Phase 2/3 clinical trial evaluating
imetelstat in transfusion dependent patients with Low or
Intermediate-1 risk myelodysplastic syndromes (MDS) who have
relapsed after or are refractory to prior treatment with an
erythropoiesis stimulating agent (ESA). The clinical trial is in
two parts: Part 1 is a Phase 2, open-label, single-arm design in
approximately 30 patients and Part 2 is a Phase 3, randomized,
double-blind, placebo-controlled design in approximately 170
patients. The primary efficacy endpoint is the rate of red blood
cell transfusion-independence lasting at least 8 weeks. Part 1 of
the trial is fully enrolled.
Janssen has conducted an initial internal review of efficacy,
safety and pharmacokinetic data from a subset of patients from Part
1 of IMergeTM and this review indicated that emerging safety and
efficacy in IMergeTM is consistent with data reported from the
pilot study conducted at Mayo Clinic in MDS patients. IMergeTM will
continue unmodified at this time.
Further assessment of data from IMergeTM is expected to occur in
the second quarter of 2017 to include longer follow-up of all
patients enrolled in Part 1. A decision on whether to move forward
to Part 2 of IMergeTM will be based on an assessment of the
benefit/risk profile of imetelstat in these patients. If Janssen
decides to move forward with Part 2, the Phase 3 clinical trial is
expected to be open for patient enrollment in mid-2017.
Janssen expects to submit data from Part 1 of IMergeTM to be
considered for presentation at a medical conference in the
future.
Conference Call
At 8:00 a.m. EDT on September 12, 2016, Geron’s management will
host a conference call to review outcomes from the internal data
reviews of IMbarkTM and IMergeTM. Participants can access the
conference call live via telephone by dialing 877-303-9139 (U.S.);
760-536-5195 (international). The passcode is 80522983. A live
audio-only webcast is also available on the company’s website at
www.geron.com under Events and at
http://edge.media-server.com/m/p/edpy9b4b. The audio webcast of the
conference call will be available for replay approximately one hour
following the live broadcast through October 13, 2016.
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 has
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. Patients in these studies also experienced
elevated liver enzymes, which resolved to normal or baseline in the
majority of patients followed after imetelstat treatment was
withdrawn. 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
IMbarkTM or IMergeTM; (ii) Janssen obtaining additional or more
mature data from IMbarkTM or IMergeTM; (iii) that the number of
patients enrolled in IMbarkTM to date is sufficient to inform
potential development of the 9.4 mg/kg dose; (iv) that Janssen will
conduct any additional or further data reviews in or protocol
amendments for IMbarkTM or IMergeTM, and the timing of such data
reviews or protocol amendments; (v) potential outcomes of any data
reviews conducted by Janssen; (vi) any future presentation of data
from current clinical trials of imetelstat by Janssen; (vii) the
safety and efficacy of imetelstat; (viii) the 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
(ix) 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 imetelstat will succeed in IMbarkTM and
IMergeTM by overcoming all of the clinical safety and efficacy,
technical, scientific, manufacturing and regulatory challenges;
(ii) whether health authorities permit IMbarkTM or IMergeTM to
continue to proceed under the existing protocols or any amendments
thereto; (iii) Janssen’s ability to collect additional and more
mature data from current clinical trials of imetelstat; (iv)
whether Janssen continues to conduct IMergeTM or IMbarkTM; (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; and (vi) whether imetelstat is safe and efficacious,
and whether any future efficacy or safety results may cause the
benefit/risk profile of imetelstat to become unacceptable.
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 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, 2016. 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 Relations
650-473-7765
investor@geron.com
media@geron.com
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