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Corcept Therapeutics Inc. (CORT) Announces Oncology Development Program


12/12/2013 12:21:13 PM

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SAN ANTONIO, TX, Dec 12, 2013 (Marketwired via COMTEX) -- Corcept Therapeutics IncorporatedCORT -0.02% , 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 theUniversity 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 to treatment.

Corcept has licensed patent rights from UChicagoTech, the University of Chicago's Center for Technology Development & Ventures, covering the use of GR antagonists 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 needed.

"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 ineffective.

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. 2. 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: American Cancer Society; 2013

4. Susan G. Komen Website, Triple-Negative Breast Cancer. 23 October 2013. Available at http://ww5.komen.org/TripleNegativeBreastCancer.html , Accessed December 6, 2013 5. Van Epps, Heather L., PHD. "Triple-Negative Breast Cancer: Divide and Conquer." Cure Today. 17 Sept. 2013 6. 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.

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