Genetic Variation Associated with Treatment Response in a Clinical Study of a New Atypical Antipsychotic Fiaptatm (iloperidone)
29 2월 2008 - 10:30PM
PR Newswire (US)
ROCKVILLE, Md., Feb. 29 /PRNewswire-FirstCall/ -- 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. DATASOURCE: Vanda Pharmaceuticals Inc. CONTACT:
Media, Rachel Martins, Vice President of Ketchum, +1-646-935-4137,
, for Vanda Pharmaceuticals Inc.; or Steven Shallcross, Chief
Financial Officer of Vanda Pharmaceuticals Inc., +1-240-599-4537;
Web site: http://www.vandapharma.com/
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