Senesco Adds Second Clinical Site to Evaluate SNS01-T in Multiple Myeloma
March 01 2012 - 8:30AM
Business Wire
Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE
AMEX: SNT) today announced that it has received Institutional
Review Board approval and has finalized a clinical trial research
agreement with the University of Arkansas for Medical Sciences
(“UAMS”) in Little Rock, Arkansas to evaluate SNS01-T, the
Company’s lead therapeutic candidate for the treatment of multiple
myeloma in the on-going Phase 1b/2a study.
The University of Arkansas for Medical Sciences (“UAMS”) is one
of the region's major academic health centers, located in
Little Rock, Arkansas, with outreach programs operating in every
county and a regional campus in Northwest Arkansas. The principal
investigator in the study at UAMS is Saad Usmani, M.D., Director of
Developmental Therapeutics in the Myeloma Institute for Research
& Therapy.
“We are very pleased to have added UAMS as a clinical site along
with the Mayo Clinic in order to accelerate patient enrollment and
increase awareness of the SNS01-T study,” stated Leslie J. Browne,
Ph.D, President and Chief Executive Officer of Senesco. “We believe
that the addition of UAMS will help accomplish both of these
objectives by broadening access to the trial.”
In the study, patients are dosed twice-weekly for 6 weeks
followed by an observation period. The first group of three
patients will receive 0.0125 mg/kg by intravenous infusion. At the
end of their 6 weeks of dosing, safety data for the group will be
reviewed before the subsequent group receives a higher dosage. The
escalated doses administered to the second to fourth groups will be
0.05, 0.2 and 0.375 mg/kg, respectively. The study is an
open-label, multiple-dose, dose-escalation study, which will
evaluate the safety and tolerability of SNS01-T when administered
by intravenous infusion to a total of approximately 15 relapsed or
refractory multiple myeloma patients. 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 including
measurement of the monoclonal protein (M-protein). Patient dosing
in the study was initiated in November, 2011 at the Mayo Clinic in
Rochester, Minnesota.
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 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
partners’ products.
Forward-Looking Statements
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 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 circumstances.
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