On April 30, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (Nasdaq: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the U.S. Food and Drug Administration ("FDA") has notified the Company that it may proceed with its proposed clinical investigation of EPI-7386 for the treatment of metastatic castration-resistant prostate cancer ("mCRPC") (Press release, ESSA, APR 30, 2020, View Source [SID1234556871]). ESSA previously announced on March 30th, 2020 that it had filed an Investigational New Drug ("IND") application for EPI-7386 with the FDA. EPI-7386 is a first-in-class N-terminal domain inhibitor of the androgen receptor.
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"This is an important milestone for ESSA and we look forward to commencing our clinical trial with EPI-7386 as a potential new therapy for the treatment of prostrate cancer," commented David R. Parkinson, MD, CEO of ESSA. "The timing of this IND acceptance keeps us on track with our initial clinical development timeline. We are working with our initial clinical sites to ensure compliance with COVID-19 risk management guidance as provided by the FDA as well as site emergency plan policies to minimize any potential impact COVID-19 may have on site activation and patient enrollment."
ESSA expects the Phase 1 clinical trial to enroll approximately 18 mCRPC patients who are progressing on standard of care at selected clinical sites, with up to 10 additional patients enrolled in a dose expansion cohort. The study will evaluate safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy. A clinical trial application ("CTA") has been submitted to Health Canada and is pending authorization.