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Genetic Variation Associated With Treatment Response In A Clinical Study Of A New Atypical Antipsychotic Fiaptatm (iloperidone)
A study reported in
the journal Pharmacogenomics suggests that a genetic variation in the
Ciliary Neurotrophic Factor gene (CNTF) may affect response to
antipsychotic treatment. The study, conducted by Vanda Pharmaceuticals
Inc., included patients with acute symptoms of schizophrenia who were
treated either with Fiapta(TM) (iloperidone), a novel atypical
antipsychotic agent currently under review with the FDA, or placebo.
Patients were also studied for a genetic variation in the CNTF gene. CNTF
is a neurotrophic factor important for neuronal survival and recovery after
injury. About 75% of the population carry two intact copies of the CNTF
protein while 25% carry one or two truncated copies of the protein.
As previously reported in the clinical study overall, it was shown that
Fiapta(TM) was significantly more effective than placebo in treating both
the positive and negative symptoms of schizophrenia. In addition,
Fiapta(TM) showed significant improvement from baseline in all symptoms
across all patient genotypes of CNTF.
In the patient population carrying both intact copies of CNTF
(representing 75% of the population), Fiapta(TM) treatment was
significantly better than placebo in symptom improvement. In patients
carrying at least one truncated copy of the CNTF protein, placebo and
Fiapta(TM) treated patients had a significant improvement from baseline
indicating an enhanced placebo response among this group of patients.
"This is a pioneering effort in understanding why some people respond
to antipsychotic medication and others do not. The results of this
prospective study on the genetics of drug response offer tantalizing clues
on the involvement of neurotrophic factors in schizophrenia," said Steven
G. Potkin, MD, Professor of Psychiatry, Robert R. Sprague Chair in Brain
Imaging, and Director, Clinical Psychiatric Research at the University of
California, Irvine.
These findings suggest that neurotrophic factors like CNTF and genetic
variations within them may play important roles in antipsychotic response
and the course of illness of patients with schizophrenia. "This study is an
important first step towards understanding the role of genetic variation in
antipsychotic treatment response and eventually the introduction of
personalized medicine in the treatment of schizophrenia," noted Dr. Anil
Malholtra, MD, Director, Division of Psychiatry Research, The Zucker
Hillside Hospital.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) is a biopharmaceutical
company focused on the development and commercialization of clinical-stage
product candidates for central nervous system disorders. The company has
three product candidates. Vanda's lead product candidate, Fiapta(TM)
(iloperidone), for which Vanda has recently submitted an NDA to the FDA, is
a compound for the treatment of schizophrenia. Vanda's second product
candidate, VEC-162, is a compound for the treatment of sleep and mood
disorders, which is currently in Phase III for chronic insomnia. Vanda's
third product candidate, VSF-173, is a compound for the treatment of
excessive sleepiness in Phase II. For more on Vanda Pharmaceuticals Inc.,
please visit http://www.vandapharma.com.
Note Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, including
statements regarding Vanda's plans for its product candidates. Words such
as, but not limited to, "look forward to," "believe," "expect,"
"anticipate," "estimate," "intend," "plan," "targets," "likely," "will,"
"would," "should," and "could," and similar expressions or words identify
forward-looking statements. Such forward-looking statements are based upon
current expectations that involve risks, changes in circumstances,
assumptions and uncertainties. Vanda is at an early stage of development
and may not ever have any products that generate significant revenue.
Important factors that could cause actual results to differ materially from
those reflected in Vanda's forward-looking statements include, among
others, a failure of Vanda's product candidates to be demonstrably safe and
effective, a failure to obtain regulatory approval for the company's
products or to comply with ongoing regulatory requirements, a lack of
acceptance of Vanda's product candidates in the marketplace, a failure of
the company to become or remain profitable, Vanda's inability to obtain the
capital necessary to fund its research and development activities, a loss
of any of the company's key scientists or management personnel, and other
factors that are described in the "Risk Factors" section (Part II, Item 1A)
of Vanda's report on Form 10-Q for the quarter ended September 30, 2007
(File No. 000-51863). No forward-looking statements can be guaranteed and
actual results may differ materially from such statements. The information
in this release is provided only as of the date of this release, and Vanda
undertakes no obligation to update any forward-looking statements contained
in this release on account of new information, future events, or otherwise,
except as required by law.
Vanda Pharmaceuticals Inc.
http://www.vandapharma.com
Variaþie geneticã, asociate cu tratamentul de rãspuns într-un studiu clinic de antipsihotice atipice Un nou Fiaptatm (iloperidone) - Genetic Variation Associated With Treatment Response In A Clinical Study Of A New Atypical Antipsychotic Fiaptatm (iloperidone) - articole medicale engleza - startsanatate