Full Press Release Details
| Company Contact: | Investor Relations Contact : | |
| Senesco Technologies, Inc. | FD | |
| Bruce Galton | Brian Ritchie | |
| Chief Executive Officer | (brian.ritchie@fd.com) | |
| (bgalton@senesco.com) | (212) 850-5600 | |
| (732) 296-8400 |
SENESCO ANNOUNCES RESULTS OF PRE-CLINICAL
TOXICOLOGY AND DOSE RANGING STUDIES FOR MULTIPLE MYELOMA
THERAPEUTIC CANDIDATE
BRUNSWICK, N.J. February 3, 2009 Senesco Technologies, Inc. ( Senesco
or the Company ) (NYSE Alternext US: SNT) today announced
results of efficacy, toxicological and dose-finding studies in mice for its
potential multiple myeloma drug candidate, SNS-01. SNS-01 is a nano-encapsulated combination
therapy of Factor5A and an siRNA against Factor 5A. These studies, undertaken to determine the efficacy,
maximum tolerated dose and the feasibility of long-term intravenous
administration of SNS-01, were performed at the University of Waterloo,
The Company s anti-myeloma efficacy study in severe combined immune-deficient
mice with human multiple myeloma subcutaneous tumors tested SNS-01 dosages
ranging from 0.15 mg/kg to 1.5 mg/kg. In
these studies, mice treated with a dose of either 0.75 mg/kg or 1.5 mg/kg both
showed a 91% reduction in tumor volume and a decrease in tumor weight of 87%
and 95%, respectively. For mice that
received smaller doses of either 0.38 mg/kg or 0.15 mg/kg, there was also a
reduction in tumor volume (73% and 61%, respectively) and weight (74% and 36%,
respectively). All of the treated mice,
regardless of dose, survived.
This therapeutic dose range provided the basis for an 8 day maximum
tolerated dose study in which normal mice received two intravenous doses of
increasing amounts of SNS-01 (from 2.2 mg/kg to 3.7 mg/kg). Body weight, organ weight and serum levels of
liver enzymes were used as clinical indices to assess toxicity. A dose between 2.2 mg/kg and 2.9 mg/kg was
well tolerated with respect to these clinical indices, and the survival rate at
2.9 mg/kg was 80%. Those mice receiving
above 2.9mg/kg of SNS-01 showed evidence of morbidity and up to 80%
mortality. The 2.9 mg/kg threshold,
twice the upper end of the therapeutic dose range, was therefore determined to
be the maximum tolerated dose in mice.
The final study, a 9-week repeated dose study in normal mice, was
designed to assess toxicity following long-term administration of twice-weekly
therapeutic doses (1.5 mg/kg) of SNS-01.
This study also included a group of mice that were dosed with a
mouse-specific eIF5A siRNA to determine whether there were any toxic effects of
suppressing eIF5A in mouse tissues. The change in mean body weight of the
treated and untreated mice was exactly the same over the course of the
study. In addition to the indices studied
in the maximum tolerated dose experiment, hematology was monitored in this
experiment. Over the course of six
weeks, both the mean red blood cell count (9.8 for control mice, 9.6 for
treated mice) and white blood cell count (7.5 for control mice, 7.2 for treated
mice) remained consistent, further supporting the conclusion that SNS-01 was
non-toxic in these studies. Histopathological analysis of the major organs was
conducted by an independent pathologist and revealed no toxicity attributable
Richard Dondero, Senesco s Vice President of Research and Development
commented, These mouse efficacy studies allowed us to determine a proposed
therapeutic dose range for SNS-01. The results of our pre-clinical toxicology
and dose-ranging studies indicate a maximum tolerated dose 2-4 times higher
than those producing anti-tumor effects in mice.
It is Senesco s goal to file an Investigational New Drug Application
for SNS-01 before the end of calendar year 2009. The Company will need to conduct longitudinal
toxicology studies and meet with the FDA during this process.
Senesco s SNS-01 consists of three components: an eIF5A plasmid, an
siRNA against eIF5A and polyethyleneiminie (PEI). The eIF5A plasmid upregulates the apoptotic
pathways within cancer cells. The siRNA
downregulates proinflammatory cytokines, NF-kB and ICAM, which are
proliferation factors for multiple myeloma.
PEI is a nanoparticle complexed to the other two components for
intravenous delivery.
Senesco Technologies, Inc.
Technologies, Inc. is a U.S. biotechnology company, headquartered in New
Brunswick, NJ. Senesco has initiated preclinical research to trigger or delay
cell death in mammals (apoptosis) to determine if the technology is applicable
in human medicine. Accelerating apoptosis may have applications to development
of cancer treatments. Delaying apoptosis may have applications to certain
diseases inflammatory and ischemic diseases. Senesco takes its name from the
scientific term for the aging of plant cells: senescence. Delaying cell breakdown
in plants extends freshness after harvesting, while increasing crop yields,
plant size and resistance to environmental stress. The Company believes that
its technology can be used to develop superior strains of crops without any
modification other than delaying natural plant senescence. Senesco has
partnered with leading-edge companies engaged in agricultural biotechnology and
earns research and development fees for applying its gene-regulating platform
technology to enhance its partners products.
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 development of the Company s gene
technology; the approval of the Company s patent applications; the
implementation of the Company s research and development programs and joint
ventures; the success of the Company s license agreements; the acceptance by
the market of the Company s products; success of the Company s preliminary
studies and preclinical research; competition and the timing of projects and
trends in future operating performance, our ability to maintain our continued
listing standards for the next 12 months, 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.