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ESSA Pharma's Interim EPI-7386 Data Shows Continuous Antigen Decline In Early-Stage Prostate Cancer Study

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  • ESSA Pharma Inc (NASDAQ: EPIX) has announced initial data from Phase 1 trial evaluating the company's lead candidate, EPI-7386, to treat patients with metastatic castration-resistant prostate cancer. Data were at the 2021 American Society of Clinical Oncology Genitourinary
  • Data highlights compare preclinical projections of EPI-7386's clinical pharmacokinetic parameters to the pharmacokinetic, safety, and preliminary clinical data from the initial 200 mg cohort in patients who progressed on two or more approved systemic therapies.
  • In this initial cohort, EPI-7386 was well-tolerated with no severe adverse events observed.
  • EPI-7386 was well-absorbed, demonstrated high exposure levels, and was confirmed to have a long half-life of at least 24 hours. The predicted exposures of EPI-7386 in patients were similar to modeled projections and were still below optimal target exposures of EPI-7386 associated with anti-tumor activity in animal models.
  • One out of three patients who completed 12 weeks of therapy experienced a prostate-specific antigen decline (PSA) of more than 50% after three cycles of EPI-7386 therapy (12 weeks) with ongoing continued PSA declines continuing through six cycles of therapy, despite previously having failed enzalutamide and abiraterone acetate.
  • ESSA recently completed the 28-Day safety evaluation period for the 400mg dose cohort and is currently dosing patients in the 600 mg cohort.
  • More clinical data is expected in the second half of 2021.
  • Price Action: EPIX stock gained 46% at $28.29 during market trading hours on the last check Thursday.
 

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Posted-In: Phase 1 TrialBiotech News Small Cap FDA General

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