Posted by Michael Wonder on 14 Sep 2020
ESSA Pharma announces fast track designation granted by the FDA to EPI-7386 for the treatment of metastatic castration-resistant prostate cancer
14 September 2020 - ESSA Pharma today announced that the US FDA granted fast track designation to EPI-7386, its oral and highly-selective N-terminal domain inhibitor of the androgen receptor, for the treatment of adult male patients with metastatic castration-resistant prostate cancer resistant to standard-of-care treatment.
The Phase 1 clinical trial expects to enrol approximately 18 metastatic castration-resistant prostate cancer patients in the dose escalation part of the study at selected clinical sites in the United States and Canada, with an additional ten patients planned to be enrolled in a dose expansion cohort involving additional clinical sites.
