Omeros Announces National Institute on Drug Abuse's Support for Phase 2 Clinical Study in Addiction Program
2010年1月28日 - 10:00PM
PRニュース・ワイアー (英語)
SEATTLE, Jan. 28 /PRNewswire-FirstCall/ -- Omeros Corporation
(NASDAQ: OMER) today announced that the National Institute on Drug
Abuse (NIDA) is providing support for the Company's Addiction
program. NIDA will fund substantially all of the costs of a Phase 2
clinical study to be conducted by New York State Psychiatric
Institute researchers. In its Addiction program, Omeros is
developing proprietary compositions that include peroxisome
proliferator-activated receptor gamma (PPAR-gamma) agonists for the
prevention and treatment of addiction to substances of abuse, such
as opioids, nicotine and alcohol, as well as other compulsive
behaviors, including eating disorders. The Company's data from
earlier European pilot clinical studies and animal models of
addiction have demonstrated a previously unknown link between
PPAR-gamma and addiction disorders. Under the agreement, the New
York State Psychiatric Institute researchers, led by Dr. Sandra D.
Comer, will conduct a Phase 2 clinical study to evaluate a
PPAR-gamma agonist in the treatment of addiction to opioids,
expected to begin enrollment in the first half of this year. The
study will be managed through the Research Foundation for Mental
Hygiene (RFMH). The responsibilities of RFMH also include the
filing of the related investigational new drug application (IND)
with the Food and Drug Administration (FDA). Funding of
substantially all of the costs of this study, including the
regulatory costs, will be provided to RFMH through a grant from
NIDA. Omeros will have the right to reference the data obtained
from this study for subsequent submissions to the FDA and will
retain all other rights in connection with its Addiction program.
"NIDA's support for this study marks an important step forward for
our program and validates its potential to prevent addiction and to
treat patients suffering from substance abuse," stated Gregory
Demopulos, M.D., Chairman and CEO of Omeros. "We recognize that the
investigators and NIDA moved quickly and we appreciate their
financial and operational support." "Our team looks forward to
getting patients enrolled in this study as soon as possible,"
stated Dr. Comer. "Addiction to opioids and other substances is a
major public health problem, and the data from Omeros' preclinical
and pilot clinical studies show that PPAR-gamma agonist therapy
holds significant promise as an effective treatment." About Omeros
Corporation Omeros Corporation is a clinical-stage
biopharmaceutical company committed to discovering, developing and
commercializing products focused on inflammation and disorders of
the central nervous system. Omeros' most clinically advanced
product candidates are derived from its proprietary
PharmacoSurgery(TM) platform designed to improve clinical outcomes
of patients undergoing arthroscopic, ophthalmological, urological
and other surgical and medical procedures. Omeros has four ongoing
PharmacoSurgery(TM) clinical development programs, and its lead
product candidate, OMS103HP, is being evaluated in Phase 3 clinical
trials for use during arthroscopic surgery to improve postoperative
joint function and reduce postoperative pain. Omeros is also
building a diverse pipeline of preclinical programs targeting
inflammation and central nervous system disorders. For more
information on Omeros, visit the Company's website at
http://www.omeros.com/. About the Addiction Program In its
Addiction program, Omeros is developing proprietary compositions
that include PPAR-gamma agonists for the prevention and treatment
of addiction to substances of abuse, such as opioids, nicotine and
alcohol, as well as other compulsive behaviors, including eating
disorders. Based on the previously unknown link between PPAR-gamma
and addiction disorders together with promising data from European
pilot clinical studies and animal models of addiction, Omeros has
filed patent applications claiming the use of any PPAR-gamma
agonist, alone or in combination with other agents, for the
prevention or treatment of addiction and other compulsions.
According to the National Institutes of Health, the socioeconomic
cost of all substance abuse in the United States alone is $484
billion per year. About the New York State Psychiatric Institute
Founded in 1896, the New York State Psychiatric Institute (PI)
contributes importantly to knowledge about the understanding and
treatment of psychiatric disorders. It is ranked among the best
psychiatric research facilities in the world today. Noted for its
research on depression and suicide, schizophrenia, anxiety and
child psychiatric disorders, PI is also at the forefront of
research dedicated to unraveling the brain's mysteries. Its
scientists constitute the core of the Department of Psychiatry at
Columbia University. The 2000 Nobel Laureate Eric Kandel, whose
laboratories are at PI, was recognized for his work in elaborating
on the cellular processes that underlie learning and memory, which
has implications for major psychiatric disorders including
Alzheimer's and for the normal decline in memory as we age. The
Institute's solid scientific footing earned its scientists a
landmark grant to support its stem cell research program in 2008.
http://www.nyspi.org/ Forward-Looking Statements This press release
contains forward-looking statements as defined within the Private
Securities Litigation Reform Act of 1995, which are subject to the
"safe harbor" created by those sections. These statements include,
but are not limited to, statements regarding the ability to begin
enrollment in the Phase 2 clinical trial to evaluate a PPAR-gamma
agonist in the treatment of addiction to opioids in the first half
of this year. Forward-looking statements are based on management's
beliefs and assumptions and on information available to management
only as of the date of this press release. Omeros' actual results
could differ materially from those anticipated in these
forward-looking statements for many reasons, including, without
limitation, the risks, uncertainties and other factors described
under the heading "Risk Factors" in the Company's Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on
November 19, 2009. Given these risks, uncertainties and other
factors, you should not place undue reliance on these
forward-looking statements, and the Company assumes no obligation
to update these forward-looking statements publicly, even if new
information becomes available in the future. DATASOURCE: Omeros
Corporation CONTACT: Carney Noensie, , or Janelle Saade, , both of
Burns McClellan, Investor & Media Relations, +1-212-213-0006
Web Site: http://www.omeros.com/
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