Senesco Announces Expansion of Phase 1b/2a Study to Include Diffuse Large
B-Cell Lymphoma and Mantle Cell Lymphoma
First DLBCL Patient Dosed in Study
BRIDGEWATER, N.J. -- November 07, 2012
Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE MKT: SNT)
reported today that the clinical trial of SNS01-T has been expanded to include
diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). The
first patient with DLBCL was enrolled in cohort 2 and received the first dose
"We are very pleased to have expanded the study to include DLBCL and MCL,
which like multiple myeloma, are B-cell cancers that SNS01-T was designed to
treat. We submitted a protocol amendment to the FDA in August in order to open
the study to patients suffering from these non-Hodgkin’s B-cell lymphomas,"
stated Leslie J. Browne, Ph.D., President and CEO of Senesco. "The ability to
include other hematological cancers broadens our results and may accelerate
patient enrollment at the three clinical sites where SNS01-T is being
investigated. This should keep us on track to disclose results of cohort 2
around the end of 2012."
Senesco previously reported that two of three patients, who completed dosing
with SNS01-T in cohort 1 had not progressed on treatment, based on criteria
including the monoclonal protein, and were considered stable at week 3 and
week 6, the end of the dosing regimen.
The trial is an open-label, multiple-dose, dose-escalation study, which is
evaluating the safety and tolerability of SNS01-T when administered by
intravenous infusion to approximately 15 relapsed or refractory multiple
myeloma, DLBCL and MCL patients. Patients are dosed twice-weekly for 6 weeks
followed by an observation period. The first group of multiple myeloma
patients received 0.0125 mg/kg, approximately 1 mg per patient, by intravenous
infusion. The second group is now receiving 0.05 mg/kg and the planned dose
levels for the third and fourth groups are 0.2 and 0.375 mg/kg, respectively.
While the primary objective of this study is to evaluate safety and
tolerability, the effect of SNS01-T on tumor response and time to relapse or
progression will be assessed using multiple well-established metrics.
SNS01-T is a novel approach to cancer therapy that is designed to selectively
trigger apoptosis in B-cell cancers such as multiple myeloma, and, mantle cell
and diffuse large B-cell lymphomas. Senesco is the sponsor of the Phase 1b/2a
study that is actively enrolling patients at Mayo Clinic in Rochester, MN, the
University of Arkansas for Medical Sciences in Little Rock, and the Mary Babb
Randolph Cancer Center in Morgantown, WV.
About Multiple Myeloma
Multiple myeloma is an incurable cancer of plasma cells, a type of white blood
cell derived from B-lymphocytes, normally responsible for the production of
antibodies, in which abnormal cells accumulate in the bone marrow leading to
bone lesions and interfering with the production of normal blood cells.
Senesco was previously granted orphan drug status for SNS01-T, the Company’s
lead drug candidate for treatment of multiple myeloma.
About Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is a form of non-Hodgkin’s lymphoma (NHL),
constituting roughly 6 percent of all NHL cases in the United States with a
prevalence of approximately 30,000 cases. It is considered an aggressive form
of B-cell lymphoma.
About Diffuse Large B-cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is a fast growing form that is the
commonest of non-Hodgkin’s lymphoma (NHL) accounting for 30 percent of new
cases every year. There are approximately 120,000 cases of DLBCL in the US.
About Senesco Technologies, Inc.
Senesco, a leader in eIF5A technology, is running a clinical study in multiple
myeloma with its lead therapeutic candidate SNS01-T, which targets B-cell
cancers by selectively inducing apoptosis by modulating eukaryotic translation
initiation factor 5A (eIF5A), which is believed to be an important regulator
of cell growth and cell death. Accelerating apoptosis may have applications in
treating cancer, while delaying apoptosis may have applications in treating
certain inflammatory and ischemic diseases. Senesco has already partnered with
leading-edge companies engaged in agricultural biotechnology and biofuels
development, and is entitled to earn research and development milestones and
royalties if its gene-regulating platform technology is incorporated into its
Certain statements included in this press release are forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995. Actual results could differ materially from such statements expressed
or implied herein as a result of a variety of factors, including, but not
limited to: the Company’s ability to continue as a going concern; the
Company’s ability to recruit patients for its clinical trial; the ability of
the Company to consummate additional financings; the development of the
Company’s gene technology; the approval of the Company’s patent applications;
the successful implementation of the Company’s research and development
programs and collaborations; the success of the Company's license agreements;
the acceptance by the market of the Company’s products; the timing and success
of the Company’s preliminary studies, preclinical research and clinical
trials; competition and the timing of projects and trends in future operating
performance, the Company’s ability to comply with the continued listing
standards of the NYSE Amex, as well as other factors expressed from time to
time in the Company’s periodic filings with the Securities and Exchange
Commission (the "SEC"). As a result, this press release should be read in
conjunction with the Company’s periodic filings with the SEC. The
forward-looking statements contained herein are made only as of the date of
this press release, and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events or
Senesco Technologies, Inc.
Chief Financial Officer
Leslie J. Browne, Ph.D.
President & CEO
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