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Vanda Pharmaceuticals Confirms Iloperidone Efficacy With Positive Phase III Clinical Trial Results In Schizophrenia
Vanda Pharmaceuticals
Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development
and commercialization of clinical-stage product candidates, today announced
positive top-line results from the company's Phase III clinical trial
evaluating iloperidone, an atypical antipsychotic, in patients with
schizophrenia. Iloperidone demonstrated statistically significant
improvement compared to placebo on the Positive and Negative Symptom Scale
(PANSS), the trial's primary endpoint. Additionally, iloperidone achieved
significant efficacy on the positive and negative symptom subscales of
PANSS. The safety profile was consistent with what has been observed in
previous iloperidone Phase III trials.
Vanda also evaluated iloperidone's efficacy and safety in patients with
specific genetic profiles using its expertise in pharmacogenetics (PG), as
part of its commitment to give physicians and patients information to help
personalize their antipsychotic therapy. Vanda had previously identified a
polymorphism in a gene, occurring in approximately 70% of patients,
hypothesized to be associated with the pathogenesis of schizophrenia which
appeared to correlate with iloperidone response. Iloperidone achieved
statistical significance vs. placebo on the PANSS scale in these patients,
with a magnitude of response greater than that seen in the overall
iloperidone population.
The Phase III trial was a randomized, double-blind, placebo-controlled,
multi-center, 4 week inpatient study that enrolled 604 patients with
schizophrenia. The trial examined iloperidone 12 mg dosed twice-daily, or
24 mg per day. The primary endpoint was efficacy vs. placebo in PANSS
(total) using the Mixed Method Repeated Measures (MMRM) methodology. The
secondary endpoint was efficacy in the genetic subpopulation.
The specific findings of efficacy vs. placebo include:
Efficacy (intent to treat population):
PANSS (total): p=0.006
PANSS (positive symptoms only): p=0.0009
PANSS (negative symptoms only): p=0.027
Brief Psychiatric Rating Scale (BPRS): p=0.0128
Efficacy (genetic subpopulation):
PANSS (total): p=0.002
Under Last Observation Carried Forward (LOCF) methodology, iloperidone
met the primary and secondary endpoints with statistical significance.
Iloperidone efficacy was also equal to the active arm.
Vanda also measured the effect of iloperidone on the QT interval, a
well understood atypical antipsychotic class side effect. The mean QT
prolongation was consistent with previous experience. No patients
experienced QT intervals in excess of 500 milliseconds, a threshold of
concern to the FDA. Vanda also confirmed with an additional genetic marker
that the QT prolongation was shorter in the majority of patients who are
good iloperidone metabolizers.
The specific findings include:
QTc change from baseline:
All patients: 11.4 milliseconds (msec)
Good metabolizers: 10.4 msec
Poor metabolizers: 15.0 msec (p=0.008, good vs. poor)
"We are extremely pleased to have achieved this outcome with
iloperidone. The success of this trial moves us one step closer to our NDA
filing, expected in late 2007, and one step closer to making iloperidone
available to patients and providers dealing with schizophrenia," stated
Paolo Baroldi, M.D., Ph.D., Senior Vice President and Chief Medical Officer
of Vanda.
"We are especially pleased to have achieved our pharmacogenetic
results," stated Mihael Polymeropoulos, M.D., President and CEO of Vanda.
"For the first time in the treatment of a psychiatric disease, we have
applied pharmacogenetic tools to identify patients best suited for a
specific drug therapy. Our market research indicates that physicians
treating schizophrenia patients would enthusiastically welcome such
information in making prescribing decisions. We are committed to further
exploration, after iloperidone approval, to identify the genetic basis of
many aspects of iloperidone response."
About Schizophrenia
Schizophrenia is a chronic, debilitating mental disorder characterized
by hallucinations, delusions, racing thoughts and other psychotic symptoms
(collectively referred to as "positive symptoms"), as well as moodiness,
anhedonia (inability to feel pleasure), loss of interest, eating and sleep
disturbances, and difficulty concentrating (collectively referred to as
"negative symptoms"). Schizophrenia develops in late adolescence or early
adulthood in approximately 1% of the world's population. Genetic and
environmental factors are believed to be responsible for the disease.
CONFERENCE CALL
The company has scheduled a conference call for today, Thursday,
December 7, 2006 at 9:00 AM ET. During the call, Mihael Polymeropoulos,
M.D., President and CEO will discuss the results of this Phase III trial.
Investors can call 1-800-638-5495 (domestic) and 1-617-614-3946
(international) prior to the 9:00 AM start time and ask for the Vanda
Pharmaceuticals conference call hosted by Dr. Polymeropoulos. A replay of
the call will be available on Thursday, December 7, 2006, beginning at
11:00 AM ET and will be accessible until Thursday, December 14, 2006, at
5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic
callers and 1-617-801-6888 for international callers. The access number is
49811320.
The conference call will be broadcast simultaneously on the company's
Web site, http://www.vandapharma.com. Investors should click on the
Investor Relations tab and are advised to go to the Web site at least 15
minutes early to register, download, and install any necessary audio
software. The call will also be archived on the Vanda Web site for a period
of 30 days, through January 6, 2007.
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 of Vanda's report
on Form 10-Q for its third quarter ended September 30, 2006. 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.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. 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 in clinical development. Vanda's lead product candidate,
iloperidone, is a compound for the treatment of schizophrenia and bipolar
disorder and is in Phase III for 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 insomnia. Vanda's third
product candidate, VSF-173, is a compound for the treatment of excessive
sleepiness and is ready for a Phase II clinical trial. For more on Vanda
Pharmaceuticals Inc., please visit http://www.vandapharma.com.
Vanda Pharmaceuticals Inc.
http://www.vandapharma.com
Vanda produse farmaceutice confirmã eficacitatea cu Iloperidone pozitiv studiu clinic de fazã III, rezultate în schizofrenie - Vanda Pharmaceuticals Confirms Iloperidone Efficacy With Positive Phase III Clinical Trial Results In Schizophrenia - articole medicale engleza - startsanatate