SOURCE: Corcept Therapeutics

Corcept Therapeutics

December 14, 2015 08:30 ET

Corcept Therapeutics Announces Initial Efficacy Results in Phase 1/2 Trial of Mifepristone in Combination With Eribulin for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer

MENLO PARK, CA--(Marketwired - Dec 14, 2015) - Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating activity at the glucocorticoid receptor (GR), presented initial efficacy data from its Phase 1/2 trial of mifepristone in combination with the chemotherapy drug eribulin to treat patients with GR-positive, metastatic, triple-negative breast cancer (TNBC). The data were presented at the 2015 San Antonio Breast Cancer Symposium (SABCS) on Saturday, December 12th, 2015.

Trial Design and Objective
Corcept is investigating whether the addition of mifepristone, the active ingredient in Corcept's approved medication, Korlym®, will enhance the effect of eribulin in patients whose TNBC tumors express GR, one of the receptors to which Korlym binds.

The trial is being conducted in two parts. In the first phase, researchers determined the maximum tolerated combined dose of mifepristone and eribulin. This dose -- 300 mg of mifepristone daily with 1.1 mg/m2 of eribulin taken on days one and eight of a three week cycle -- is now being administered to patients in the trial's second, efficacy phase, which will enroll 20 patients with GR-positive, metastatic TNBC. This phase of the trial is ongoing.

Initial Efficacy Results
At SABCS, the trial's investigators presented efficacy data from the 15 patients enrolled to-date with GR-positive TNBC who have been treated with the recommended dose (two patients from the trial's first phase and 13 from its second). As determined using the Response Evaluation Criteria in Solid Tumors (RECIST), initial efficacy results in this group were as follows: one patient exhibited a partial response (defined as a 30 percent or greater reduction in tumor size), seven had stable disease and five had progressive disease. Two patients were too early in their treatment to be assessed.

The combination of mifepristone and eribulin has been well-tolerated. Most adverse events have been disease-related and of mild or moderate severity, with the most common being neutropenia, fatigue, hypokalemia, nausea, hair loss and neuropathy. Neutropenia has been manageable with the administration of growth factor. No patient has suffered a serious adverse event. Pharmacokinetic data show no interaction between eribulin and mifepristone.

"We are pleased that the combination of mifepristone and eribulin appears to be active in these very ill patients," said Robert S. Fishman, MD, Corcept's Chief Medical Officer. "Our oncology program is based on the hypothesis that GR modulators such as mifepristone can enhance the efficacy of a variety of chemotherapeutic agents in GR-positive disease. We very much look forward to completing the trial. If the final results are sufficiently positive, we plan to initiate a Phase 3 trial of this treatment regimen next year."

Corcept's trial builds on pre-clinical and clinical research performed by investigators at Corcept and at the University of Chicago showing that modulation of activity at GR enhances the effect of chemotherapy in the treatment of TNBC. At the 2013 SABC, University of Chicago researchers presented positive results of a trial in which six patients with metastatic, GR-positive TNBC received a combination of nab-paclitaxel and mifepristone.

About Triple-Negative Breast Cancer
TNBC is a form of breast cancer in which the three receptors that fuel most breast cancer growth -- estrogen, progesterone and HER-2 -- are not present. Because the tumor cells lack these receptors, treatments that target estrogen, progesterone and HER-2 are ineffective. Approximately 40,000 women are diagnosed with triple-negative breast cancer each year. It is estimated that more than 75 percent of these women's tumor cells express GR. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed triple-negative breast cancer patients exists.

Corcept has licensed patents from the University of Chicago covering the use of GR antagonists in combination with chemotherapy to treat TNBC and castration-resistant prostate cancer. 

About Korlym® (mifepristone)
Korlym modulates the effects of excess cortisol in patients with Cushing's syndrome. Since 2012, Corcept has marketed Korlym as a once-daily oral treatment of 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. Korlym was the first FDA-approved treatment for that illness, and the FDA has designated Korlym as an Orphan Drug for that indication.

About Corcept Therapeutics Incorporated
Corcept discovers, develops and commercializes drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol. Korlym is the company's first FDA-approved medication. The company has developed a proprietary portfolio of next-generation compounds that modulate the effects of cortisol, but not progesterone. The company plans to commence Phase 2 trials of its lead next-generation compound, CORT125134, for the treatment of an oncology indication and Cushing's syndrome in the first quarter of 2016. Corcept holds composition of matter patents on its next-generation molecules and owns or has exclusively licensed extensive intellectual property covering the use of cortisol modulators, including Korlym, in the treatment of a wide variety of serious disorders.

Forward-Looking Statements
Statements made in this press release, other than statements of historical fact, are forward-looking statements that are subject to 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 include statements regarding the timing and results of ongoing and future clinical trials, the advancement of Corcept's next-generation selective cortisol modulators, the protections afforded Corcept's intellectual property rights, and the cost, pace and success of Corcept's other product development efforts. These and other risks are set forth in the company's SEC filings, which are available at the company's website (www.corcept.com) or from the SEC's website (www.sec.gov). Corcept disclaims any intention or duty to update any forward-looking statement made in this press release.

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