Senesco Provides SNS01-T Update on Phase 1b/2a Multiple Myeloma Trial
04 June 2012 - 10:30PM
Business Wire
Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE
MKT: SNT) reported today on the progress of its Phase 1b/2a study
for the treatment of multiple myeloma, which is the subject of a
poster presented today at the 2012 Annual Meeting of the American
Society of Clinical Oncology.
To date five patients have been enrolled into the study. So far
one patient has completed the 6 week dosing schedule. This
patient’s disease was considered stable, no disease progression,
based on key disease markers including monoclonal protein when
evaluated at the end of weeks 3 and 6. Two patients were withdrawn
from the study due to disease progression, and two patients are
currently being treated. No disease limiting toxicities have been
recorded to date.
“We are encouraged that there is an indication that SNS01-T is
performing as designed even at this low dose,” stated Harlan
Waksal, M.D., Chairman of Senesco. “At this dose level we had
expected to evaluate only safety. So seeing an indication of
activity, even in a single patient, is a bonus.”
In the study, patients are dosed twice-weekly for 6 weeks
followed by an observation period. The first group of patients
receives 0.0125 mg/kg by intravenous infusion. At the end of 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.
“We are pleased that the SNS01-T study is progressing well.
Provided there are no more withdrawals we expect to complete the
first dosing group during the last week of June,” stated Leslie J.
Browne, Ph.D., President and Chief Executive Officer of Senesco.
“Although we experienced an initial delay in patient enrollment, we
believe that the rate of recruitment into the study is back on
plan.”
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 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 monoclonal protein.
About SNS01-T
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.
http://www.clinicaltrials.gov/ct2/show/NCT01435720?term=SNS01-T&rank=1
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
Company’s ability to recruit and enroll patients in its clinical
trial; 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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