Corcept
Therapeutics Incorporated (Nasdaq: CORT) announced today that it completed
patient enrollment in Study 06, the third of three Phase 3 clinical trials
in which CORLUX(R) (mifepristone) is being evaluated for treating the
psychotic features of psychotic major depression (PMD). The company expects
to announce the results in late February 2007.
A total of 441 patients have been enrolled in Study 06, a randomized,
double-blind, placebo-controlled trial, at 40 sites in the United States
and 5 sites in Europe. The primary endpoint is the proportion of patients
with at least a 50% improvement in the Brief Psychiatric Rating Scale
Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 56. The BPRS is
an 18-item rating instrument used to assess psychopathology and the PSS
includes the four items in the BPRS that specifically measure psychosis.
BPRS assessments will be conducted at baseline and Days, 7, 14, 28, 42 and
56. Patients must have at least mild psychotic symptoms (BPRS PSS > or =
12) to enter the studies and will be hospitalized if clinically necessary.
Patients were evenly distributed among three active dose groups (300
mg, 600 mg and 1200 mg) or a placebo group and patients received once daily
dosing for a period of seven days. All patients in the study must not have
taken any antidepressant or antipsychotic medication for at least one week
before the seven-day treatment period. All patients receive antidepressant
therapy starting on Day 1 through Day 56. As with Corcept's two previously
completed Phase 3 clinical trials evaluating CORLUX for the treatment of
PMD, Study 07 and Study 09, treatment with antipsychotic medications or
electroconvulsive therapy is not be allowed at any time during this study.
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 bipolar I disorder. PMD 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, FDA
agreements, and the timing of the completion of pivotal Phase 3 trials.
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, completion or success of clinical
trials; the regulatory process or regulatory approvals, or commercial
success. In addition, 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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