Contact Information: For further information: Corcept Therapeutics www.corcept.com Joseph K. Belanoff, M.D. Chief Executive Officer Tel.: + 1 650-327-3270 E: Xceleron Inc. www.xceleron.com Prof. Colin Garner Chief Executive Officer Tel: + 44 (0) 1904 561561 Scott Tarrant Vice President, Business Development for North America Tel.: +1 240 361 1900 Media enquiries De Facto Communications Richard Anderson / Sylvie Berrebi Tel: + 44 (0) 20 7861 3838 E:
Corcept Therapeutics and Xceleron Sign Agreement for Microdosing Study Using Accelerator Mass Spectrometry
| Source: Corcept Therapeutics
MENLO PARK, CA--(Marketwire - July 25, 2007) - Corcept Therapeutics (NASDAQ : CORT ) and
Xceleron today announced an agreement for a human microdosing study of one
of Corcept's new chemical entities, a selective GR-II antagonist, utilizing
Xceleron's Accelerator Mass Spectrometry (AMS) technology.
In early 2003, Corcept initiated a discovery research program to identify
and patent selective GR-II antagonists to develop a pipeline of products
for proprietary use. Three distinct series of GR-II antagonists were
identified. These compounds appear to be as potent as Corcept's lead
product CORLUX® in blocking cortisol but, unlike CORLUX, they do not
block the progesterone or other steroid receptors. Corcept will evaluate
one of the compounds, one which develops particularly high plasma and brain
concentrations in an animal model, in a human microdosing study using
Xceleron's AMS technology.
Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept, said, "We
look forward to testing the bioavailability of our proprietary specific
cortisol receptor antagonists in man. There are many potential clinical
uses for cortisol blocking agents, particularly those that do not block the
activity of other hormones. Our collaboration with Xceleron, and the use of
their highly innovative approach, will save Corcept significant time and
cost."
Xceleron will carry out the work using ultra-sensitive AMS. This most
sensitive measuring device enables human drug-metabolite profiling to be
performed in the early stages of clinical development. This type of
analysis allows drug developers to detect and measure ultra-low levels of
both known and previously unknown metabolites producing data that isn't
available using other analytical techniques. Early human profiling also
helps identify the most suitable species for use in long term toxicology
and pharmacology studies.
Notes to Editors
About Xceleron
Xceleron is a global leader in analytical strategies for drug development.
It is a proven partner to a range of over 100 pharma-biotech businesses,
adding value through optimisation of Exploratory Clinical Development
programmes.
Xceleron is a successful, fast-growing business, recognised as the leader
in its field and rich in intellectual property and know-how. Operating as a
drug development centre of excellence the information Xceleron generates
enables its partners to exercise informed decisions on new candidate
biologics and drugs, faster and more cost-effectively than competing
technologies.
Xceleron delivers a range of smart approaches to Exploratory Clinical
Studies in Microdosing, Mass Balance, Absolute Bioavailability and
Metabolite Profiling. By building its own substantive and innovative R & D
programme in association with worldwide drug developers Xceleron continues
to deliver new ultra-sensitive analytical services including Accelerator
Mass Spectrometry (AMS) molecule analysis, drug-drug interactions,
metabolic-markers, protein labelling, standards and clinical data
interpretation.
More information can be obtained on www.xceleron.com
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of drugs for the treatment of severe psychiatric and
metabolic diseases. Corcept's lead product, CORLUX, is currently in Phase
3 clinical trials for the treatment of the psychotic features of psychotic
depression. The drug is administered orally 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 psychotic
depression.
In June 2007, Corcept announced positive results from its proof of concept
study evaluating the ability of CORLUX to mitigate weight gain associated
with the administration of olanzapine, a commonly used antipsychotic
medication. The Company is in the process of fully evaluating all of the
data from that study and considering its next steps. Earlier this month
the Company announced that it received Orphan Drug Designation from the
Food and Drug Administration for CORLUX for the treatment of endogenous
Cushing's Syndrome. For additional information about the company, please
visit www.corcept.com.
Statements made in this news release, other than statements of historical
fact, are forward-looking statements, including, for example, statements
relating to Corcept's clinical development programs, and its spending
plans. 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 by such statements. For
example, there can be no assurances with respect to the commencement, cost,
rate of spending, completion or success of clinical trials; financial
projections may not be accurate; there can be no assurances that the
investigations for future clinical trials will be completed, or that
Corcept will pursue further activities with respect to clinical development
of CORLUX. These and other 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.