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, granted in December 2015, for the treatment of castration-resistant prostate cancer (CRPC) in patients resistant to Zytiga (abiraterone) or Xtandi (enzalutamide).
Innocrin is now recruiting patients for two other Phase 2 trials (NCT02012920 and NCT02445976) in additional evaluations of seviteronel in CRPC patients.
“We believe that the award of a second Fast Track designation for seviteronel, in addition to men with castration-resistant prostate cancer (CRPC), is continued FDA recognition of the compound’s potential to address significant unmet medical need in hormone-dependent cancers,” Eshelman, Innocrin’s new CEO, said in a press release.
“As the lead investor of Innocrin’s last round of financing, I am fully committed to the success of the seviteronel clinical development programs, since the drug provides novel treatment options for breast and prostate cancer sub-types where patients have failed other therapies,” he said. “I am not only investing in seviteronel, but also betting on members of the development team as I join the company’s day-to-day leadership.”