Senesco Initiates Dosing in Phase 1b/2a Clinical Study of SNS01-T
November 03 2011 - 8:30AM
Business Wire
Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE
Amex: SNT) today announced the initiation of patient dosing in its
Phase 1b/2a clinical study of SNS01-T at the Mayo Clinic in
Rochester, MN. 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 relapsed or refractory multiple myeloma patients.
"We are excited that the SNS01-T study is underway and intend to
provide material updates as it progresses," stated Leslie J.
Browne, Ph.D., President and CEO of Senesco. "Although the trial is
primarily designed to confirm pre-clinical safety and tolerability
in patients, we are keenly interested in getting a look at the
battery of tumor response markers including M-protein and
C-reactive protein that could provide evidence of a response."
The study design calls for twice-weekly dosing of patients for 6
weeks followed by a 4 week observation period at the end of dosing
before escalating to the next higher dose level. While the primary
objective of this initial study is to evaluate safety and
tolerability, the effect of SNS01-T on time to relapse or
progression and tumor response will be assessed using multiple
well-established metrics including measurement of the monoclonal
protein (M-protein). The first group of three patients will receive
0.0125 mg/kg by intravenous infusion twice-a-week for 6 weeks. The
escalated doses administered to the second to fourth groups will be
0.05, 0.2 and 0.375 mg/kg, respectively. A total of approximately
15 patients are expected to be in the study which is planned to
last about one year. Senesco intends to open a second clinical site
to enhance the rate of patient recruitment.
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 Technologies is leveraging proprietary technology that
regulates programmed cell death, or apoptosis. Accelerating
apoptosis may have applications in treating cancer, while delaying
apoptosis may have applications treating certain inflammatory and
ischemic diseases. The Company has initiated a clinical study in
multiple myeloma with its lead therapeutic candidate SNS01-T.
Senesco has already partnered with leading-edge companies engaged
in agricultural biotechnology 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.
Senesco (AMEX:SNT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Senesco (AMEX:SNT)
Historical Stock Chart
From Jul 2023 to Jul 2024