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Intra-Cellular Therapies Initiates Phase I Clinical Program For Schizophrenia And Sleep Maintenance Disorders
Intra-Cellular Therapies, Inc., today
announced it has initiated Phase I clinical trials for ITI-007, the
Company's first-in-class dual 5HT2A receptor antagonist/dopamine receptor
phosphoprotein modulator (DPPM) for the treatment of schizophrenia, and
ITI-722, a low dose formulation of ITI-007 with selective 5HT2A receptor
antagonist properties for the treatment of sleep maintenance insomnia. The
primary objective of these studies is to determine the pharmacokinetics,
safety, and maximum tolerated dose (MTD) of ITI-007 in healthy volunteers
as a prelude to efficacy studies for the treatment of acute psychotic
symptoms in patients with schizophrenia and for the treatment of sleep
maintenance insomnia. Both ITI-007 and ITI-722 are part of a large
portfolio of compounds originally licensed from Bristol Myers Squibb
Company (BMY).
"We are pleased ITI-007 and ITI-722 are moving forward into clinical
studies. These programs have a novel combination of pharmacologic
properties, that have the potential to define the future of antipsychotic
drug therapy and treatment of sleep maintenance disorders," stated Sharon
Mates, Ph.D., Chairman and Chief Executive Officer of Intra-Cellular
Therapies. "We believe this approach may have significant treatment
advantages over currently marketed drugs and also should be free of many
unwanted side effects associated with current therapies."
About ITI-007
ITI-007 is an orally available compound which combines potent 5HT2A
receptor antagonism with cell-type-specific modulation of phosphoprotein
pathways downstream of dopamine receptors. As a dopamine receptor
phosphoprotein modulator (DPPM), ITI-007 has dual properties; it acts as a
post-synaptic antagonist and as a pre-synaptic partial agonist. The
combination of ITI-007's high-potency blockade of 5HT2A receptors and
unique dopamine receptor activity will make it possible for the first time,
to select a clinical dose capable of saturating 5HT2A receptors while
permitting the "dialing in" of an optimal amount of dopamine receptor
modulation. The ability to optimize the level of dopamine receptor
modulation holds promise for the reduction of psychotic symptoms without
incurring high levels of dopamine antagonism that cause motor disturbances
and other deleterious side effects. In addition, the wide separation of
affinity at 5HT2A and D2 receptors may allow for administration of the
appropriate amount of dopamine modulation for antipsychotic maintenance
therapy and the treatment of bipolar disorders.
ITI's technology platform CNSProfile(TM) has revealed ITI-007 is a
novel phosphoprotein modulator, selectively blocking overactive dopamine
responsive phosphoprotein pathways without stimulating compensatory
dopamine synthesis, demonstrating ITI-007's unique, partial agonist-like
properties. Standard pharmacologic assays have confirmed ITI-007's partial
agonist properties at the presynaptic dopamine D2 receptor and confirmed
serotonin transporter antagonist activity which may be of added benefit to
patients with schizoaffective disorder and other diseases associated with
mood alterations. ITI-007 has a much lower propensity than several
currently marketed antipsychotic drugs to bind receptors that mediate
deleterious cardiovascular events, sedation and rapid and significant
weight gain.
About ITI-722
A low-dose formulation of ITI-007, called ITI-722, is being developed
simultaneously for the treatment of sleep maintenance insomnia in the
general population. Due to the unique separation of D2 and 5HT2A receptor
affinities, at low doses, ITI-722 acts primarily as a 5HT2A receptor
antagonist. Additionally, its profile suggests the compound may be
appropriate for the treatment of sleep disorders that accompany
neurodegenerative disorders, such as Parkinson's disease.
About Schizophrenia
Schizophrenia is a major neuropsychiatric disorder that affects over 1%
of the world population with an illness that begins in late adolescence and
lasts a lifetime. Its best known symptoms are 'positive symptoms' which
include hallucinations and delusions; but other mental functions are also
affected, including social and motivational skills ('negative symptoms')
and cognitive behaviors, like inattention and poor memory. Current
antipsychotics are effective primarily on reducing positive symptoms but
leave negative and cognitive symptoms untouched. Not only are current drugs
incompletely active, but they also have limiting side effects, including
troublesome actions on motor function, weight gain and metabolic symptoms
(diabetes and hyperlipidemia), along with sedation, constipation,
dizziness, and loss of bladder control. Few people with schizophrenia
regain normal psychosocial function; the medical need in this disease area
is enormous.
About Sleep Maintenance Disorders
From nightmares to insomnia to sleep apnea, sleep disorders disrupt the
sleep of millions of people all over the world. In particular, about 20% to
30% of the U.S. population complains of waking too early at least a few
times a week, a symptom of sleep maintenance insomnia which is
characterized by symptoms which include waking up frequently during the
night with difficulty returning to sleep, waking up at early hours and
unrefreshing sleep. The majority of sleep complaints are related to sleep
maintenance insomnia rather than sleep initiation or difficulty in falling
asleep. However, there are no drugs currently approved in the U.S. that
only address sleep maintenance insomnia. Furthermore, current sleep
medications typically induce sedation and result in significant increases
in daytime sleepiness that impairs the quality of life in these patients.
There is, therefore, a significant need for sleep medications that improve
sleep quality without residual daytime sedation.
CNSProfile(TM)
The Company has developed a state-of-the-art technology platform,
called CNSProfile(TM) that is capable of generating a unique molecular
signature for drug compounds. Specifically, CNSProfile(TM) measures the
levels of phosphoproteins -- proteins chemically linked at specific sites
to phosphates. This profile provides the company with a proprietary and
unique window into the intracellular action of CNS drugs or drug
candidates. Intra-Cellular Therapies uses this platform in its drug
discovery and development efforts of proprietary compounds and also to
evaluate in-licensing opportunities.
About Intra-Cellular Therapies
Intra-Cellular Therapies, Inc. (ITI), is a biopharmaceutical company
that is developing novel drugs for the treatment of diseases and disorders
of the CNS. Building on the science generated from the Nobel Prize winning
laboratory of Dr. Paul Greengard at The Rockefeller University, the Company
develops compounds that have the potential to treat a wide range of
diseases associated with the CNS. To aid in the development process, the
Company incorporates its CNSProfile(TM), a state-of-the-art platform that
allows ITI to choose compounds with the strongest potential to succeed in
these difficult to treat diseases.
Intra-Cellular Therapies, Inc.
http://www.intracellulartherapies.com
Intra-terapii celulare iniþiazã clinice de faza I de program pentru schizofrenie ºi tulburãri de somn de întreþinere - Intra-Cellular Therapies Initiates Phase I Clinical Program For Schizophrenia And Sleep Maintenance Disorders - articole medicale engleza - startsanatate