Senesco Announces Results of Pre-Clinical Efficacy, Toxicology and Dose Ranging Studies for Multiple Myeloma Therapeutic Candida
February 03 2009 - 8:00AM
PR Newswire (US)
NEW BRUNSWICK, N.J., Feb. 3 /PRNewswire-FirstCall/ -- 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, Ontario, Canada. 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 2.9
mg/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 to
SNS-01. 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. About
SNS-01 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. About Senesco Technologies, Inc. Senesco
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. 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 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 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. Company Contact:
Investor Relations Contact: Senesco Technologies, Inc. FD Bruce
Galton Brian Ritchie Chief Executive Officer () () (212) 850-5600
(732) 296-8400 DATASOURCE: Senesco Technologies, Inc. CONTACT:
Bruce Galton, Chief Executive Officer, Senesco Technologies, Inc.,
+1-732-296-8400, ; Investor Relations Contact: Brian Ritchie, FD,
+1-212-850-5600, , for Senesco Technologies, Inc. Web Site:
http://www.senesco.com/
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