воскресенье, 22 мая 2011 г.

Corcept Therapeutics Announces Negative Results From The Second Of Three Phase 3 Studies Evaluating CORLUX(R) For Treating Psychotic Features

Corcept Therapeutics Incorporated (Nasdaq: CORT), today announced that the second
of its three Phase 3 trials evaluating CORLUX for treating the psychotic
features of Psychotic Major Depression (PMD) was negative.



Study 09 was a randomized, double-blind, placebo-controlled study. The
primary endpoint, a responder analysis, was the proportion of patients with
at least a 50 percent improvement in the Brief Psychiatric Rating Scale
Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28.


Specifically, the BPRS is an 18-item rating instrument used to assess
psychopathology, and the PSS is a subset of four items in the BPRS that
specifically measure psychosis. The study revealed no meaningful separation
in response between patients receiving CORLUX and patients receiving
placebo. The two key secondary endpoints of Study 09 were similarly
negative.



"As was the case in Study 07, our previously announced Phase 3 clinical
trial, there was an unusually high placebo response rate in Study 09,"
noted Robert L. Roe, M.D., Corcept's President and head of Development. "At
Day 56, for example, approximately 95 percent of the patients in both of
the arms of the study were responders as measured by a 50 percent
improvement in BPRS PSS score."



"Although not the primary or a key secondary endpoint, it is
interesting to note that there was a statistically significant separation
between the CORLUX and placebo groups on an endpoint commonly used to
measure the efficacy of antipsychotic and antidepressant medications,
change from baseline to study end, in this case, Day 56," said Joseph K.
Belanoff, M.D., Corcept's Chief Executive Officer. "However, because of the
already high degree of response in the placebo group, it is difficult to
determine how much additional clinical utility is conferred by this
finding."



Corcept now has one Phase 3 study in progress. "We continue to enroll
patients in Study 06 and expect to announce the results of this trial early
next year," said Dr. Belanoff.



Commenting on Corcept's financial guidance, Fred Kurland, Corcept's
Chief Financial Officer, stated, "Based on the timeline of our clinical
development program, we expect that our available cash and marketable
securities, which were $17.5 million at June 30, 2006, will enable us to
complete and announce the results of our remaining Phase 3 clinical study."



Conference Call and Live Webcast on September 29, 2006



Management will host a conference call on September 29, 2006 at 9:00
a.m. EDT to provide an update on its PMD clinical program. To participate,
please dial 800-257-2101 for domestic calls or 303-262-2130 for
international calls. A telephone replay will also be available by dialing
800-405-2236 for domestic calls or 303-590-3000 for international calls.
The access code is 11072650. The replay will be available until 4:00 p.m.
EDT on October 13, 2006.

















A live webcast of the conference call can be accessed at



corcept. The event will be archived and available for replay until


4:00 p.m. EDT on October 13, 2006.



About Psychotic Major Depression



PMD is a serious psychiatric disorder that affects about three million
people in the United States every year. It is more prevalent than either
schizophrenia or manic depression. The disorder is characterized by severe
depression accompanied by delusions, hallucinations or both. People with
PMD are approximately 70 times more likely to commit suicide than the
general population and often require lengthy and expensive hospital stays.
There is no FDA-approved treatment for PMD.



About Corcept Therapeutics Incorporated



Corcept Therapeutics Incorporated is a pharmaceutical company focused
on developing drugs for treating severe psychiatric and neurological
diseases. Corcept's lead product, CORLUX, is in Phase 3 clinical trials for
treating the psychotic features of PMD. The drug is administered orally to
PMD patients once per day for seven days. CORLUX, a potent GR-II
antagonist, appears to reduce the effects of the elevated and abnormal
release patterns of cortisol seen in PMD. The company has also initiated a
proof-of-concept study to evaluate the ability of CORLUX to mitigate weight
gain associated with the use of olanzapine. For more information, please
visit corcept.



Forward-looking Statements



Statements made in this news release -- other than statements of
historical fact -- are forward-looking statements. These include
information relating to Corcept's PMD clinical development program, the
timing of the completion of its remaining pivotal Phase 3 trial and
projections of the availability of cash. Forward-looking statements are
subject to a number of known and unknown risks and uncertainties that might
cause actual results to differ materially from those expressed or implied
here. For example, there can be no assurances on the efficacy, safety,
enrollment completion or success of clinical trials; the regulatory process
or regulatory approvals; or commercial success. In addition, financial
projections and trial timetables may not be accurate. Risk factors are
explained in the company's SEC filings, all of which are available from its
Web site ( corcept ) or from the SEC's Web site ( sec ).



The company does not have any intention or duty to update forward-looking
statements made in this news release.


Corcept Therapeutics Incorporated

corcept

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