US Oncology Research Joins Corcept Therapeutics' Phase I Breast Cancer Study
April 02 2014 - 12:15PM
Marketwired
US Oncology Research Joins Corcept Therapeutics' Phase I Breast
Cancer Study
Multi-Center Study Now Enrolling Patients at US Oncology
Research Affiliated Sites in Texas and Virginia
MENLO PARK, CA and THE WOODLANDS, TX--(Marketwired - Apr 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 US Oncology 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, the 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.
Investor Contact Charles Robb Corcept Therapeutics Incorporated
Chief Financial Officer Email Contact 650-688-8783 Media Contacts
Claire Crye US Oncology Research Email Contact Tel: 281-825-9927
Erich Sandoval for Corcept Lazar Partners Ltd. Email Contact Tel:
+1 917 497 2867
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