понедельник, 18 апреля 2011 г.

Corcept Therapeutics Announces Negative Results From The First Of Three Phase 3 Studies Evaluating CORLUX(R) For Psychotic Major Depression

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


Study 07 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 56.
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 that 30.5 percent of the
patients receiving CORLUX and 28.6 percent of the patients receiving
placebo were responders (p value = .762). The two key secondary endpoints
of Study 07 were similarly negative.


"There was an unusually high placebo response rate in this trial,"
noted Robert L. Roe, M.D., Corcept's President and head of development. "At
Day 56, for example, approximately 80 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."


"While we are of course disappointed by these results, we have two
other Phase 3 trials under way," said Joseph K. Belanoff, M.D., Corcept's
Chief Executive Officer. "Next month, we expect to announce the results of
Study 09, which completed its enrollment of 247 patients in late May. We
continue to enroll patients in Study 06 and expect to announce the results
of this trial by the end of this year or early next year."


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 two remaining Phase 3 clinical
studies."


Conference Call and Live Webcast on August 25, 2006


Management will host a conference call on August 25, 2006 at 9:00 a.m.
EDT to provide an update on its PMD clinical program. To participate,
please dial 800-867-0448 for domestic calls or 303-262-2140 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 11069588. The replay will be available until 4:00 p.m.
EDT on September 12, 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 September 12, 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 pivotal Phase 3 trials 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; 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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