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Tokai Pharma terminates late-stage study of lead product candidate in prostate cancer; shares plummet 70% premarket

Jul. 26, 2016 8:43 AM ETEledon Pharmaceuticals, Inc. (ELDN) StockJNJ, MDVN, ALPMF, ALPMY, AR, ELDNBy: Douglas W. House, SA News Editor
  • Thinly traded micro cap Tokai Pharmaceuticals (TKAI) craters 70% premarket on higher-than-normal volume in response to its announcement that it will stop its Phase 3 clinical trial, ARMOR3-SV, assessing lead product candidate galeterone compared to enzalutamide (XTANDI) in treatment-naive men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the androgen receptor splice variant AR-V7. The company made its decision based on the recommendation from the independent Data Monitoring Committee that the trial was unlikely to meet its primary efficacy endpoint.
  • Tokai intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to enzalutamide and its planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate (ZYTIGA).
  • Galeterone is an orally available small molecule that disrupts the androgen receptor (NYSE:AR) signaling pathway by degrading AR, blocking the binding of testosterone or dihydrotestosterone with AR and inhibiting CYP17, an enzyme that plays a key role in the synthesis of testosterone. Prostate cancer is stoked by androgens acting through the androgen receptor.
  • Related tickers: (NASDAQ:MDVN)(OTCPK:ALPMF)(OTCPK:ALPMY)(NYSE:JNJ)

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