Innocrin Names New CEO and Gets Fast-tracked by FDA for Breast Cancer Treatment Seviteronel

Innocrin Names New CEO and Gets Fast-tracked by FDA for Breast Cancer Treatment Seviteronel
Innocrin Pharmaceuticals has named Fred Eshelman, PharmD, as its new CEO and learned it was granted a second fast track designation for seviteronel (VT-464) for the treatment of several types of breast cancers. The U.S. Food and Drug Administration (FDA) fast-tracked seviteronel for advanced androgen receptor-positive (AR+), triple-negative breast cancer (TNBC) and advanced estrogen receptor-positive (ER+) breast cancer. Seviteronel is an oral, once-daily drug that selectively inhibits CYP17 lyase, an enzyme necessary for the synthesis of androgen and estrogen. Seviteronel also directly blocks the androgen receptor, which is thought to stimulate disease progression of breast cancer tumors that no longer express the estrogen receptor, or that do, but have become resistant to ER-targeting. Innocrin has recently completed the enrollment of women with ER+ breast cancer in the Phase 2 CLARITY-01 study (NCT02580448), and continues enrolling women with TNBC and men with ER+ breast cancer. The study will enroll up to 110 participants to establish a maximum tolerated dose, based on dose-limiting adverse events of seviteronel. It will also measure other effectiveness parameters, including overall response rate, progression-free survival, and clinical benefit. Updated results from the trial are planned to be presented at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting June 2-6 in Chicago. The FDA's Fast Track Program is designed to facilitate the development and review of drugs that fill an unmet medical need. The second fast track designation for breast cancer follows a first designation, gr
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