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Geron Corporation
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.
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 http://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.
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