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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT THERAPEUTICS
COMMENCES SECOND PIVOTAL PHASE III CLINICAL TRIAL OF CORLUX
MENLO PARK, Calif., October 19, 2004 - Corcept Therapeutics Incorporated,
(NASDAQ: CORT), a pharmaceutical company, today announced the commencement
of its second pivotal Phase III clinical trial, known as Corcept 06, evaluating
CORLUX (mifepristone) for the treatment of the psychotic features
of Psychotic Major Depression (PMD). Corcept anticipates having initial
results from both the first and second pivotal studies available in the
first half of 2006. CORLUX has been granted Fast Track designation for
this indication.
"We are
on track with our development plans for CORLUX," said Joseph K. Belanoff,
M.D., Corcept's chief executive officer. "PMD is a disorder that
affects approximately three million people in the United States each year
and for which there are no FDA-approved treatments. Through our studies,
we will investigate whether CORLUX will provide rapid and sustained relief
from the psychotic symptoms of this crippling illness."
"The 06
study is the second of our pivotal studies to commence in the United States
and like the 07 study which began to enroll patients in September is being
conducted according to a Special Protocol Assessment agreement with the
FDA, said Robert L. Roe, M.D., Corcept's President. "Our highly experienced
in-house clinical development team has forged strong relationships with
our contract research organizations to help ensure that these studies
are conducted according to the rigorous standards required for registration."
Corcept 06 Study
Details
Corcept 06 will enroll approximately 440 patients at about 30 sites in
the United States in a randomized, double-blind, placebo-controlled trial
of CORLUX. 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 greater than or equal
to 12) to enter the studies and will be hospitalized if clinically necessary.
Patients will be evenly
distributed among three active dose groups (300 mg, 600 mg and 1200 mg)
or a placebo group with patients receiving once daily dosing for a period
of seven days. All patients in the study must be off any antidepressant
and antipsychotic medication for at least one week before the seven day
treatment period and will receive antidepressant therapy starting on Day
1 through Day 56. As with Corcept 07, treatment with antipsychotic medications
or electroconvulsive therapy will not be allowed at any time during this
study.
About Psychotic
Major Depression
PMD is a serious psychiatric disorder that affects approximately three
million people annually in the United States. It is more prevalent than
either schizophrenia or manic depressive illness. 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 engaged
in the development of drugs for the treatment of severe psychiatric and
neurological diseases. Corcept's lead product, CORLUX, is currently
in Phase III clinical trials for the treatment of the psychotic features
of psychotic major depression. The drug is administered orally to PMD
patients once per day for seven days. CORLUX, a potent GR-II antagonist,
appears to mitigate the effects of the elevated and abnormal release patterns
of cortisol seen in PMD. Corcept is also conducting a clinical trial to
evaluate the safety and efficacy of our product in improving cognition
in patients with mild to moderate Alzheimer's disease. For additional
information about the company, please visit www.corcept.com.
Forward Looking
Statements
Statements made in this news release, other than statements of historical
fact, are forward-looking statements, including, for example, statements
relating to our PMD clinical development program, FDA agreements and the
timing of the start and completion of pivotal Phase III trials. Forward-looking
statements are subject to a number of known and unknown risks and uncertainties
which might cause actual results to differ materially from those expressed
or implied by such statements. For example, there can be no assurances
with respect to the commencement, efficacy, safety, completion or success
of clinical trials, there can be no assurances with respect to the regulatory
process or regulatory approvals, there can be no assurances with respect
to commercial success, and financial projections and trial timetables
may not be accurate. Risk factors are set forth in the Company's SEC filings,
all of which are available from our website (www.corcept.com) or from
the SEC's website (www.sec.gov). We disclaim any intention or duty to
update any forward-looking statement made in this news release.
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