ESSA Pharma Shares Tank As Janssen Stops Enrollment In EPI-7386 Combo Prostate Cancer Trials

  • ESSA Pharma Inc EPIX announced that Johnson & Johnson's JNJ Janssen is suspending enrollment into the Phase 1 study of EPI-7386 with apalutamide or EPI-7386 with abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer (mCRPC) patients due to operational challenges. 
  • Before suspending enrollment, Janssen treated three mCRPC patients (pre-chemotherapy) with the combination of EPI-7386 and apalutamide or abiraterone acetate plus prednisone for up to four months of therapy. 
  • Related: ESSA Pharma's EPI-7386 Monotherapy / Combo Therapy Show Early Activity Against Prostate Cancer.
  • In all three patients, the combination of both investigational drug products was safe and well tolerated and yielded sufficient exposures of each drug product, indicative of pharmacological activity. 
  • Initial clinical activity was observed in some patients, with two of three achieving a prostate-specific antigen (PSA) reduction of 90% within 12 weeks.
  • "We are in discussions with Janssen to supply abiraterone acetate and apalutamide for an ESSA-sponsored combination study and expect to provide more details in the coming months," said David Parkinson, CEO of ESSA.
  • Price Action: EPIX shares are down 22% at $3.44 on the last check Monday.
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