Corcept Therapeutics Announces Oncology Development Program
Five of Eight Patients With Relapsed, Metastatic Triple-Negative
Breast Cancer (TNBC) Experienced a Partial or Complete Response With
Mifepristone and Chemotherapy Combination According to Data Presented
at the San Antonio Breast Cancer Symposium 2013; Company Files
Investigational New Drug Application With FDA to Launch Phase I Study
in Relapsed Metastatic TNBC
SAN ANTONIO, TX -- (Marketwired) -- 12/12/13 -- Corcept Therapeutics
Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the
discovery, development and commercialization of drugs for the
treatment of severe metabolic, psychiatric and oncologic disorders,
announced plans to extend its development program for glucocorticoid
receptor (GR) antagonists, including mifepristone, into oncology. The
decision is based on a body of early clinical and pre-clinical data
from leading academic institutions including the University of
Chicago showing the significant role that cortisol, a glucocorticoid
stress hormone, and its receptors play in chemotherapy resistance,
particularly for women with relapsed, metastatic triple-negative
breast cancer (TNBC), a form of the disease with a poor prognosis.
Rita Nanda, M.D., Associate Director, Breast Medical Oncology,
University of Chicago Medicine, today announced results of an
investigator-sponsored Phase I study of mifepristone in combination
with chemotherapy agent nab-paclitaxel (Abraxane(R))(1) at the San
Antonio Breast Cancer Symposium 2013 (Abstract P2-16-21).
"We are encouraged by the results of our study, which found that five
of the eight patients with relapsed metastatic triple-negative breast
cancer who participated in the trial exhibited a partial or complete
clinical response to treatment with mifepristone plus nab-paclitaxel.
The combination of mifepristone and chemotherapy was well-tolerated,"
Dr. Nanda said. "We are excited to continue our clinical
investigation into this promising therapeutic approach."
One additional patient in the study who had
estrogen-receptor-positive metastatic breast cancer did not respond
Corcept has licensed patent rights from UChicagoTech, the University
of Chicago's Center for Technology Development & Ventures, covering
the use of GR a
ntagonists in combination with chemotherapy in the
treatment of estrogen-receptor-negative breast cancer, a form of
cancer than includes TNBC.
Based on the University of Chicago's positive study and years of in
vitro and animal research, Corcept has filed an investigational new
drug (IND) application with the U.S. Food and Drug Administration
(FDA) and will conduct its own multi-center, Phase I clinical study
of mifepristone in combination with chemotherapy drug eribulin
(Halaven(R) Injection)(2) in patients with relapsed, metastatic TNBC.
The University of Chicago and other leading cancer treatment centers
will participate in this open-label Phase I study of up to 40
patients with metastatic TNBC, including an expansion phase with
efficacy endpoints in GR-positive TNBC.
"Over the last decade and a half, we have worked to identify
signaling pathways that help triple-negative breast cancer cells
resist the effects of chemotherapy," said Suzanne Conzen, M.D.,
Professor of Hematology/Oncology at University of Chicago Medicine.
"Our laboratory discovered that glucocorticoids play an important
role in activating pathways in these cells that allow them to survive
despite chemotherapy. Based on those findings, we hypothesized that
targeting the glucocorticoid receptor with the antagonist
mifepristone might prevent this downstream cell survival response and
allow chemotherapy to be more effective against breast cancer."
The American Cancer Society estimates that more than 234,000 women in
the U.S. were diagnosed with breast cancer in 2013 and an estimated
39,620 will die of the disease by the end of the year(3). Research
shows that TNBC accounts for 15 to 20 percent of new cases(4), yet
causes roughly one-in-four of all breast cancer-related deaths(5).
Unlike hormone-receptor-positive and HER-2-amplified breast cancers,
there is no FDA-approved treatment for TNBC and neither a targeted
treatment nor a preferred standard chemotherapy regimen for relapsed
TNBC patients exists. The median survival of patients with advanced
TNBC is approximately six months based on a retrospective review of
more than 3,700 patients(6). Targeted treatment approaches are
"We increasingly appreciate the profound physiological role that
cortisol plays in many conditions and diseases," said Joseph K.
Belanoff, M.D., Corcept's Chief Executive Officer. "We would like to
thank Dr. Conzen, Dr. Nanda and Dr. Gini Fleming, Director of the
Medical Oncology Breast Program at University of Chicago Medicine,
for their years of dedication to understanding the implications of
glucocorticoids and their receptors' activity in patients with
advanced breast cancer. This work has laid the groundwork for the use
of mifepristone for metastatic TNBC. We look forward to dosing the
first patient in our study early in the first quarter of 2014."
About Triple Negative Breast Cancer (TNBC)
Research shows that TNBC occurs more often in younger women,
African-American women, Hispanic/Latina women and women who have
BRCA1 mutations. A diagnosis of triple-negative breast cancer means
that the three most common types of receptors known to fuel most
breast cancer growth -- estrogen, progesterone, and the HER-2/neu
gene -- are not present in the cancer tumor. Since the tumor cells
lack the necessary receptors, common treatments like hormone therapy
and drugs that target estrogen, progesterone, and HER-2 are
About the San Antonio Breast Cancer Symposium
For thirty-six years, the Symposium's mission has been to provide
state-of-the-art information on breast cancer research. From a
one-day regional conference, the Symposium has grown to a five-day
program attended by a broad international audience of academic and
private researchers and physicians from over 90 countries. The
Symposium aims to achieve a balance of clinical, translational, and
basic research, providing a forum for interaction, communication, and
education for a broad spectrum of researchers, health professionals,
and those with a special interest in breast cancer.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery,
development and commercialization of drugs for the treatment of
severe metabolic, psychiatric and oncologic disorders. Korlym, a
first generation GR antagonist, is the company's first FDA-approved
medication for use in the treatment of patients with Cushing's
syndrome. Corcept has a phase 3 trial underway for mifepristone for
treatment of the psychotic features of psychotic depression, as well
as a portfolio of selective GR antagonists that block the effects of
cortisol without blocking the effects of progesterone. It owns
extensive intellectual property covering the use of GR antagonists,
including mifepristone, in the treatment of a wide variety of
metabolic, psychiatric and oncologic disorders. It also holds
composition of matter patents for its selective GR antagonists. For
more information about Corcept please visit: www.corcept.com
1. Abraxane(R) is a registered trademark of Celgene Corporation.
Halaven(R) is a registered trademark used by Eisai Inc. under license
from Eisai R&D Management Co., Ltd.
3. American Cancer Society.
Cancer Facts & Figures 2013. Atlanta: Am
erican Cancer Society; 2013
4. Susan G. Komen Website, Triple-Negative Breast Cancer. 23 October
2013. Available at
December 6, 2013
5. Van Epps, Heather L., PHD. "Triple-Negative
Breast Cancer: Divide and Conquer." Cure Today. 17 Sept. 2013
Kennecke H, Yerushalmi R, Woods R, et al. Metastatic behavior of
breast cancer subtypes. J Clin Oncol. 2010;28(20):3271-7.
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995
Statements made in this news release, other than statements of
historical fact, are forward-looking statements. 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. Forward-looking
statements in this news release include but are not limited to
statements regarding the timing and potential findings of the study
of mifepristone in combination with chemotherapy in the treatment of
metastatic triple-negative breast cancer. Actual results may differ
materially from those anticipated in these forward-looking
statements. Factors that may contribute to such differences include,
among others, Corcept's ability to initiate and conduct clinical
trials, the pace of enrollment in or the outcome of those trials, the
protections afforded by Corcept's patents and other intellectual
property rights, and the effects of rapid technological change and
competition. These and other risks are set forth in Corcept's SEC
filings, all of which are available from the company's website
(http://www.corcept.com) or from the SEC's website
(http://www.sec.gov). Corcept disclaims any intention or duty to
update any forward-looking statement made in this news release,
except as may be required by law.
Chief Financial Officer
Corcept Therapeutics Incorporated
Erich Sandoval for Corcept
Lazar Partners Ltd.
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