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U.S. Oncology Research Joins Corcept Therapeutics Inc. (CORT)' Phase I Breast Cancer Study


4/3/2014 10:23:57 AM

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MENLO PARK, CA and THE WOODLANDS, TX--(Marketwired - April 02, 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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