Corcept Initiates Trial of Relacorilant Plus Nab-Paclitaxel and Bevacizumab in Patients With Platinum-Resistant Ovarian Cancer
Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced the start of BELLA, a Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab evaluating efficacy and safety in patients with platinum-resistant ovarian cancer.
BELLA is a single-arm, open-label trial with a planned enrollment of 90 women with recurrent, platinum-resistant ovarian cancer at approximately 50 sites in North America, Europe and Asia-Pacific. Patients will receive relacorilant in combination with nab-paclitaxel and bevacizumab.
"In our pivotal Phase 3 ROSELLA trial, treatment with relacorilant and nab-paclitaxel improved patients' progression-free and overall survival, without increasing their side effect burden," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "BELLA will examine whether combining relacorilant with two medications – nab-paclitaxel and bevacizumab – will offer patients an additional treatment option."
About Relacorilant
Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing's syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.
About Platinum-Resistant Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.
About Cortisol's Role in Oncology
Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body's immune response, which weakens its ability to fight disease.
About Corcept Therapeutics
For over 25 years, Corcept's focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators and GR antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website.
In this press release, forward-looking statements include statements concerning: our ROSELLA trial and the potential of relacorilant combined with nab-paclitaxel to benefit patients; our BELLA trial, including its enrollment, site locations and the potential of relacorilant combined with nab-paclitaxel and bevacizumab to benefit patients; relacorilant's efficacy and safety in any clinical setting; its potential to receive regulatory approval; and the scope and protective power of our intellectual property and relacorilant's orphan drug designation. We disclaim any intention or duty to update forward-looking statements made in this press release.
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