Attached files
file | filename |
---|---|
8-K - Eloxx Pharmaceuticals, Inc. | v207065_8k.htm |
Senesco
Technologies’ Lead Therapeutic Candidate SNS01-T Granted Orphan Drug Status from
FDA for Treatment of Multiple Myeloma
New Brunswick, N.J. (January
3rd, 2011) — Senesco
Technologies, Inc. (“Senesco” or the “Company”) (NYSE Amex: SNT), announced
today that the U.S. Food and Drug Administration (FDA) has granted orphan drug
designation for the company’s lead drug candidate SNS01-T for treatment of
multiple myeloma. As a result, the company is eligible to receive a number of
benefits, including tax credits, access to grant funding for clinical trials,
accelerated FDA approval, allowance for marketing exclusivity after drug
approval for a period of as long as seven years and potential
exemption from the FDA's prescription drug application fee.
“We are
pleased that the FDA has granted orphan drug status for our lead therapeutic
candidate SNS01-T as we prepare to begin our clinical studies in multiple
myeloma,” said Leslie J. Browne, Ph.D., Chief Executive Officer. “Orphan drug
designation can provide us with significant regulatory and financial advantages
to rapidly move our candidate forward in clinical trials. We believe that the
tumor growth inhibition observed during preclinical studies is very promising
and that orphan drug status could allow Senesco to accelerate clinical
development and hopefully make this therapy available to patients
sooner.”
The
United States Orphan Drug Act of 1983 was created to promote the development of
new drug therapies for the treatment of diseases that affect fewer than 200,000
individuals in the United States. Multiple myeloma is a cancer of
plasma cells, a type of white blood cell
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. Up to two-thirds of
patients with the disease currently survive less than 5 years. Senesco was
previously granted $244,479 in immediately available funds from the U.S.
government under the Qualified Therapeutic Discovery Project (“QTDP”) in
connection with the Company’s multiple myeloma program.
About
Senesco Technologies, Inc.
Senesco
Technologies is leveraging proprietary technology that regulates programmed cell
death, or apoptosis. Accelerating apoptosis may have application in treating
cancer, while delaying apoptosis may have application in certain inflammatory
and ischemic diseases. The Company is preparing to initiate a human clinical
trial 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; success of the Company’s
preliminary studies and preclinical research; 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.
Contact:
Company
Contact:
Senesco
Technologies, Inc.
Leslie J.
Browne, Ph.D.
President
& CEO
732-296-8400
or
Investor
Relations Contact:
CEOcast,
Inc.
Dan
Schustack,
212-732-4300
dschustack@ceocast.com