2012-12-04 00:23:58 -
Company to Host Conference Call at 8:30 a.m. ET on Tuesday, December 4
MENLO PARK, Calif., December 3, 2012 - Geron Corporation (Nasdaq: GERN) today
announced that the company has discontinued development of GRN1005, its peptide-
drug conjugate designed to treat cancers in the brain. Going forward, the
company will focus on the development of imetelstat, its telomerase inhibitor,
in hematologic myeloid malignancies and in patients with solid tumors that have
short telomeres. The company also announced a restructuring to reduce its
workforce from 107 positions to 64 full-time positions, and to reduce its annual
cash operating expenses from approximately $65 million in 2012 to approximately
$33 million in 2013, which includes non-recurring costs of approximately $3
million associated with the restructuring and approximately $3 million for the
discontinuation of clinical
trials. The company expects to end 2012 with
approximately $90 million in cash and investments.
Rationale for Discontinuing GRN1005
The decision to discontinue development of GRN1005 was made after the company
completed a planned interim analysis for futility for GRABM-B, the company's
Phase 2 study in patients with brain metastases arising from breast cancer. This
analysis showed that there were no confirmed intra-cranial responses, as
determined by an Independent Review Facility, among the first 30 evaluable
patients in the trial. Data from the analysis will be presented in a poster at
the San Antonio Breast Cancer Symposium on December 6. In addition, the company
is discontinuing GRABM-L, its Phase 2 study in patients with brain metastases
arising from non-small cell lung cancer, because of the inability to
successfully enroll the trial. Geron has provided to Angiochem, Inc. notice of
termination of both the exclusive license agreement under which Geron received
rights to GRN1005 and an associated research collaboration and option agreement.
"We are very disappointed that the results of the GRN1005 program fell short of
our criteria for further development," said John A. Scarlett, M.D., Geron's
President and Chief Executive Officer. "Our immediate focus now is on the use of
imetelstat in hematologic malignancies and solid tumors with short telomeres,
which represent an opportunity for significant therapeutic advances and value
creation."
Imetelstat Development in Hematologic Malignancies
Geron will be reporting the results of a phase 2 study of single agent
imetelstat in patients with essential thrombocythemia (ET) in an oral
presentation at the American Society of Hematology annual meeting on December
9. The ET study was designed to provide proof-of-concept for the potential use
of imetelstat as a treatment for various hematologic myeloid malignancies,
including myelofibrosis, myelodysplastic syndromes and acute myelogenous
leukemias. JAK2 mutations are quantified during the trial to evaluate the effect
of the drug on the malignant progenitor cells driving the disease. The top-line
results from 14 patients enrolled in this study, all of whom were refractory to
or intolerant of conventional therapies, showed a hematologic response rate of
100% (with 93% of patients achieving a complete response) and a molecular
response rate of 86% among the seven patients who had a JAK2 mutation. These
hematologic and molecular response rates, which exceeded the company's
expectations, suggest a selective inhibition of the malignant progenitor cells
responsible for the patients' malignancy, and therefore potential disease-
modifying activity by imetelstat that may be applicable in other hematologic
myeloid malignancies.
Based on these results, Dr. Ayalew Tefferi, M.D., at the Mayo Clinic has begun
an investigator-sponsored pilot study to evaluate safety and efficacy of
imetelstat in patients with myelofibrosis, a myeloproliferative neoplasm in the
same spectrum of diseases as ET. For more information about this study, please
refer to
clinicaltrials.gov/ct2/show/NCT01731951. The company is in the
initial planning stages of a Geron-sponsored Phase 3-enabling study in
myelofibrosis, which will be informed, in part, by data from the Mayo Clinic
study. In addition, Geron intends to expand its directed program of
investigator-sponsored trials in 2013 to other hematologic myeloid indications,
including acute myelogenous leukemias.
Imetelstat Development in Solid Tumors Associated with Short Telomeres
Published non-clinical data have demonstrated that tumor cells with short
telomeres are more sensitive to telomerase inhibition with imetelstat than tumor
cells with longer telomeres. To evaluate this hypothesis clinically, Geron
included a pre-specified sub-group analysis of results by tumor telomere length
in its randomized Phase 2 trial of imetelstat in non-small cell lung cancer. In
September 2012, Geron reported that an unplanned interim safety and efficacy
analysis of the data from that trial suggested a modest but not statistically
significant trend in progression-free survival in favor of the imetelstat
treatment arm in the overall study population (hazard ratio = 0.78). However,
the pre-specified sub-group analysis suggested that imetelstat-treated patients
whose tumors had short telomeres at baseline experienced a clinically
meaningful, statistically significant increase in progression-free survival
compared to patients in the control arm (n = 19; hazard ratio = 0.32; p =
0.042), which was not observed in imetelstat-treated patients whose tumors had
medium-to-long telomeres (n = 38; hazard ratio = 0.83; p = 0.62). The company
expects to present the data from the full sub-group analysis at a scientific
conference in 2013. The company is working on a refined assay to prospectively
measure telomere length in individual patient tumor samples, which would be
required if Geron conducts a Phase 3-enabling clinical study of the effect of
imetelstat in patients with solid tumors that have short telomeres.
Management Changes
In connection with the restructuring, Graham Cooper, the company's Chief
Financial Officer, will be leaving the company to pursue other opportunities.
Olivia Bloom, currently Vice President of Finance, Chief Accounting Officer and
Treasurer, will assume the role of Chief Financial Officer effective December 7.
In addition, Geron has appointed Craig C. Parker, as Senior Vice President,
Corporate Development and as a member of the executive management team,
effective immediately. Mr. Parker has over 25 years experience in the science
and business of the biotechnology industry, and was most recently Senior Vice
President, Strategy and Corporate Development at Human Genome Sciences, Inc.,
until its sale to Glaxo SmithKline in 2012.
"I sincerely thank Graham for his many contributions to Geron's programs, and
wish him success in his future ventures," commented Dr. Scarlett. "I look
forward to working with Olivia in her new role, for which she is highly
qualified based on her many years of outstanding performance at the company, and
I welcome Craig, whose extensive experience in business development and
strategic analysis will complement our current team."
Conference Call
At 8:30 a.m. ET on December 4, 2012, Geron's management will host a conference
call to discuss the strategic realignment of the company.
Participants can access the conference call via telephone by dialing
866-713-8565 (U.S.); 617-597-5324 (international). The passcode is 32236649. A
live audio-only webcast is also available at
edge.media-
server.com/m/p/t9tr3r34/lan/en. The audio webcast of the conference call will be
available for replay approximately one hour following the live broadcast for 30
days.
About Geron
Geron is a biopharmaceutical company developing first-in-class therapies for
cancer, including its telomerase inhibitor, imetelstat. 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 Geron's plans or
expectations for or of: dates to obtain or present data or other results from
any clinical trials; and clinical development plans or success of imetelstat,
including without limitation the refinement of an assay; expecting to end 2012
with approximately $90 million in cash and investments; having annual cash
operating expenses of approximately $65 million in 2012 and approximately $33
million in 2013; and incurring one-time costs for restructuring of approximately
$3 million and non-recurring costs for the discontinuation of clinical trials of
approximately $3 million 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: (a) regarding dates for the
availability of data or other results - delays in enrollment, delays caused by
institutional review boards or regulatory agencies, shortage of supply,
dependence on clinical trial collaborators and safety issues; (b) regarding the
development of imetelstat - those risks and uncertainties inherent in the
development of potential therapeutic products, including without limitation,
successful clinical trial results and the protection of Geron's intellectual
property rights; and (c) regarding financial expectations - if any of (a) above,
unanticipated expenses or charges may occur as a result of the resizing, or
litigation were to occur. Additional information 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, 2012. 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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Source: Geron Corp. via Thomson Reuters ONE
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