The company’s lead asset is seviteronel (formerly VT-464), a dual mechanism selective CYP17 lyase and androgen receptor (AR) inhibitor. Intervention of these pathways with abiraterone (Zytiga™), a nonselective CYP17 inhibitor, and enzalutamide (Xtandi™), an AR antagonist, are approved for the treatment of CRPC, and more recently have demonstrated signs of early clinical benefit for breast cancer. Ongoing clinical studies are evaluating oral seviteronel as a novel therapeutic for estrogen receptor-positive (ER+) and triple negative breast cancer (TNBC) as well as for CRPC.
Seviteronel is a novel, non-steroidal, orally-active small molecule and, due to its high lyase selectivity, is the only member of the CYP17 inhibitor class that reduces androgens and estrogens without altering the synthesis of mineralocorticoids or glucocorticoids. Seviteronel is administered once-daily and does not require prednisone supplementation. Seviteronel is therefore highly differentiated from abiraterone, which requires prednisone co-administration to limit mineralocorticoid excess symptoms, secondary to its potent inhibition of CYP17 hydroxylase. No signs of mineralocorticoid excess have been observed in the more than 100 men and women treated with seviteronel. Nor have cardiac signals or liver enzyme elevations been observed suggesting the potential to use seviteronel in combination with other promising cancer drugs of complementary classes.
Seviteronel is being investigated in a Phase 2 clinical trial to treat women and men who have ER+ breast cancer or TNBC. Seviteronel is also being evaluated in Phase 2 clinical trials in men with CRPC whose disease has progressed following treatment with abiraterone or enzalutamide or both. Our Phase 2 programs focus on advanced cancers that represent a major unmet medical need for women and men.
Seviteronel Clinical Development Studies
Seviteronel is in Phase 2 clinical development for both breast and prostate cancer. Patients are joining the studies at clinics and major medical centers across the United States. If you or a loved one are interested in participating in one of the studies described below, and would like more information, please contact Keishea Williams at: 919-799-2037.
Breast Cancer Clinical Studies
Study 006: A Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of VT-464 in Patients With Advanced Breast Cancer
Currently enrolling women with triple-negative breast cancer and women and men with ER(+) breast cancer.
Prostate Cancer Clinical Studies
Study 001: A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Patients with Castration-Resistant Prostate Cancer.
Currently enrolling men with castration-resistant prostate cancer who were previously treated with both abiraterone and enzalutamide.
Study 002: A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of VT-464 in Patients with Metastatic Castration Resistant Prostrate Cancer Who Have Previously Been Treated With Enzalutamide
Currently enrolling men with castration-resistant prostate cancer who were previously treated with enzalutamide.
Study 003: A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Once-Daily Oral VT-464 in Patients with Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone
Currently enrolling men with castration-resistant prostate cancer who were previously treated with enzalutamide, abiraterone or both.
Study 004: A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once-Daily VT-464 in Patients with Castration-Resistant Prostate Cancer.
Enrollment for the study is complete.