Intra-Cellular Therapies Announces Presentations on Lumateperone Schizophrenia Program at the American Psychiatric Associatio...
May 15 2019 - 8:00AM
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a
biopharmaceutical company focused on the development of
therapeutics for central nervous system (CNS) disorders, announced
the presentation of posters highlighting the lumateperone program
in schizophrenia at the 2019 American Psychiatric
Association (APA) Annual Meeting in San
Francisco, May 18-22, 2019. Lumateperone is a novel
investigational drug currently under review by the FDA as a
potential treatment for adults with schizophrenia.
The upcoming presentations at APA highlight the lumateperone
clinical program in schizophrenia with posters showing
lumateperone’s clinical results including its favorable safety and
tolerability profile documented in the program
The titles of the poster presentations are as follows:
Tuesday, May 21, 2019, 10:00 a.m.-12:00 p.m. PT
- “The Efficacy of Lumateperone 42mg in the Treatment of
Schizophrenia: A Pooled Analysis of Randomized Controlled Trials”
(P7-067). The lead author is Carol Tamminga, MD, Lou and Ellen
McGinley Distinguished Chair in Psychiatric Research at the
University of Texas Southwestern Medical School.
- “The Safety and Tolerability of Lumateperone 42mg for the
Treatment of Schizophrenia: A Pooled Analysis of 3 Randomized
Placebo-Controlled Trials” (P7-04). The lead author is John M Kane,
MD, Chairman Department of Psychiatry at the Zucker Hill Hospital
and the Donald and Professor & Chair, Psychiatry at the Barbara
Zucker School of Medicine at Hofstra/Northwell.
About Lumateperone for the Treatment of
Schizophrenia
Lumateperone, our lead product candidate, is a molecule that
provides selective and simultaneous modulation of serotonin,
dopamine, and glutamate - three neurotransmitter pathways
implicated in severe mental illness. Lumateperone is a potent
serotonin 5-HT2A receptor antagonist, a dopamine receptor
phosphoprotein modulator (DPPM) acting as a presynaptic partial
agonist and postsynaptic antagonist at dopamine D2 receptors, a
dopamine D1 receptor-dependent indirect modulator of glutamate
(both NDMA and AMPA), and a serotonin reuptake inhibitor. This
compound has the potential to benefit patients suffering from a
range of neuropsychiatric and neurodegenerative diseases.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the
treatment of neuropsychiatric and neurodegenerative diseases and
diseases of the elderly, including Parkinson's and Alzheimer's
disease. The Company is developing its lead drug candidate,
lumateperone (also known as ITI-007), for the treatment of
schizophrenia, bipolar disorder, behavioral disturbances in
patients with dementia, including Alzheimer's disease, depression
and other neuropsychiatric and neurological disorders. Lumateperone
is under review by the FDA for the treatment of
schizophrenia and is in Phase 3 clinical development for the
treatment of bipolar depression. Intra-Cellular
Therapies is also utilizing its phosphodiesterase (PDE)
platform and other proprietary chemistry platforms to develop drugs
for the treatment of CNS and other disorders. The lead molecule in
the Company's PDE1 portfolio, ITI-214, is in development for the
treatment of symptoms associated with Parkinson's disease and for
the treatment of heart failure.
Forward-Looking Statements
This news release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, the safety and efficacy of our
product development candidates; the potential for lumateperone to
benefit patients suffering from a range of neuropsychiatric and
neurodegenerative diseases and development efforts and plans under
the caption “About Intra-Cellular Therapies.” All such
forward-looking statements are based on management's present
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such statements. These risks and uncertainties include
but are not limited to the following: whether the NDA for
lumateperone for the treatment of schizophrenia will be approved by
the FDA and whether the FDA will complete its
review within the target timelines; the risk that the NDA will not
be approved despite the FDA’s acceptance of the NDA for review or
that the FDA will require additional information; risks
associated with our current and planned clinical trials; we may
encounter unexpected safety or tolerability issues with
lumateperone in ongoing or future trials and other development
activities; our other product candidates may not be successful or
may take longer and be more costly than anticipated; product
candidates that appeared promising in earlier research and clinical
trials may not demonstrate safety and/or efficacy in larger-scale
or later clinical trials; our proposals with respect to the
regulatory path for our product candidates may not be acceptable to
the FDA; our reliance on collaborative partners and other
third parties for development of our product candidates; and the
other risk factors detailed in our public filings with
the Securities and Exchange Commission. All statements
contained in this press release are made only as of the date of
this press release, and we do not intend to update this information
unless required by law.
Contact:
Intra-Cellular Therapies, Inc. Juan Sanchez, M.D. Vice
President, Corporate Communications and Investor Relations
646-440-9333
Burns McClellan, Inc. Lisa Burns agray@burnsmc.com
212-213-0006
MEDIA INQUIRIES:
Patrick Ryan, Esq. Corporate Media Relations, W2Owcg
pryan@wcgworld.com
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