Multi-center study now enrolling patients at US Oncology Research affiliated sites in Texas and Virginia
MENLO PARK, Calif. and THE WOODLANDS, Texas (April 2, 2014) — 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, and
USOncology Research, one of the largest community-based research programs in the United States, announced today that two
sites affiliated with US Oncology Research will participate in Corcept’s
multi-center, Phase I clinical study of mifepristone in combination with
chemotherapy drug eribulin (Halaven®)(1) in patients with
metastatic or locally advanced unresectable breast cancer.
“Our research has focused primarily on metastatic triple-negative breast
cancer, an aggressive form of cancer with a particularly poor prognosis.
Currently, there is no FDA-approved treatment or standard chemotherapy
regimen,” said Joyce
O’Shaughnessy, M.D., the US Oncology Research study lead and the Celebrating
Women Chair of Breast Cancer Research at Texas Oncology - Baylor Charles A.
Sammons Cancer Center. “We are pleased to be working with Corcept to
investigate the potential that mifepristone may have in the treatment of this
devastating disease.”
Up to 20 patients with metastatic breast cancer will be eligible to enroll
in the first phase of the study, which will determine the maximum tolerated
dose of the mifepristone – eribulin combination. Up to an additional 20
patients with glucocorticoid receptor-positive metastatic triple-negative
breast cancer will be enrolled into a subsequent expansion phase. This portion
of the study will include efficacy endpoints.
The US Oncology Research participating sites include Texas Oncology - Baylor Charles A.
Sammons Cancer Center, led by principal investigator Carlos Becerra,
M.D. and
Virginia Cancer
Specialists, led by Alex
Spira, M.D., PhD, F.A.C.P.
In December 2013, Corcept
announced plans to extend its development program for glucocorticoid receptor
(GR) antagonists, including mifepristone, into oncology. The decision was 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 triple-negative breast cancer. Blocking the glucocorticoid receptor with
mifepristone might retard the anti-apoptotic effect of high levels of
circulating cortisol and make chemotherapy more effective against a variety of
cancers.
“Our collaboration with US Oncology Research will allow
Corcept to benefit from its network of wide-ranging expertise in the field of
oncology,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. “Their
support and participation will allow patients to be enrolled rapidly as we move
forward to complete our Phase I study.”
For more information on the study, please visit
clinicaltrials.gov, study identifier NCT02014337.
About Triple-Negative
Breast Cancer
Triple-negative breast cancer is a form of the disease in
which the three receptors that fuel most breast cancer growth – estrogen,
progesterone, and the HER-2/neu gene – are not present. Since the tumor cells
lack the necessary receptors, common treatments, such as hormone therapy and
drugs that target estrogen, progesterone, and HER-2, are ineffective. More than 230,000 women in the United States will
be diagnosed with breast cancer in 2014(2). Triple-negative breast
cancer accounts for about 15 to 20 percent of new cases and causes roughly
one-in-four of all breast cancer-related deaths.(3)(4) There are no FDA approved treatments and no standard
of care for relapsed triple-negative breast cancer patients.
About US Oncology Research
Supported by
McKesson Specialty Health and The US Oncology Network, US Oncology Research
draws from a network of experienced investigators and dedicated clinical staff
who specialize in Phase I through Phase IV oncology clinical trials. US
Oncology Research serves approximately 80 research sites and 225 locations
managing about 225 active trials at any given time. Physicians in the research
network have enrolled more than 57,000 patients in nearly 1,300 trials since
inception in 1992 and have played a role in 48 FDA-approved cancer therapies,
nearly one-third of all cancer therapies approved by the FDA to date. For more
information call (800) 482-6700 or visit www.usoncology.com/oncologists.
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. The FDA has approved the company’s first
drug, Korlym® (mifepristone) 300 mg Tablets, a glucocorticoid
receptor antagonist, as a once-daily oral treatment for hyperglycemia secondary
to endogenous Cushing’s syndrome in adult patients with glucose intolerance or
diabetes mellitus type 2 who have failed surgery or are not candidates for
surgery. The company also has a phase 3 trial underway for
mifepristone for treatment of psychotic depression and a portfolio of selective
GR antagonists that block the effects of cortisol but not progesterone. It owns
or has licensed extensive intellectual property covering the use of GR
antagonists, including mifepristone, in the treatment of a wide variety of
metabolic and psychiatric disorders and triple-negative breast cancer. It also holds composition of matter patents
for its selective GR antagonists.
- 1. Halaven® is a registered trademark used by Eisai
Inc. under license from Eisai R&D Management Co., Ltd.
- 2. American Cancer Society. Cancer Facts & Figures 2014.
Atlanta: American Cancer Society; 2014
- 3. Susan G. Komen Website, Triple-Negative Breast Cancer.
October 2013.
Available at http://ww5.komen.org/uploadedFiles/Content_Binaries/KOMEED079100.pdf, Accessed February
18, 2014 - 4. Van Epps, Heather L., PHD. "Triple-Negative Breast
Cancer: Divide and Conquer." Cure Today. 17 Sept. 2013
Statements made in this news release, other than statements
of historical fact, are forward-looking statements, including statements
relating to the clinical trials being undertaken by US Oncology Research, University
of Chicago and Corcept and the possible effect of mifepristone in the treatment
of triple-negative breast cancer. 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. There can be no assurances
regarding the pace of enrollment in or the outcome of the company’ study of
mifepristone in the treatment of triple-negative breast cancer, or the cost,
pace and success of Corcept’s product development efforts. These and other risks are set forth in the
company’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.
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