Failure in pivotal Phase III study obliterates stock at Tokai Pharmaceuticals
pharmafile | July 27, 2016 | News story | Research and Development | phase III, prostate cancer, tokai pharmaceuticals
Shares at Tokai Pharmaceuticals have been sent into freefall following the suspension of a pivotal Phase III trial for their prostate cancer drug, galeterone, after the trial’s independent data monitoring committee highlighted that the drug was unlikely to meet its primary endpoint.
The ARMOR3-SV trial was set up to compare galeterone with Xtandi (enzalumatide) in treatment-naïve metastatic castration-resistant prostate cancer patients whose prostate cancer tumours express AR-V7.
The trial’s independent data monitoring committee reviewed the safety and efficacy data on the trial and concluded that that galeterone was unlikely to meet its primary endpoint of demonstrating an improvement in radiographic progression-free survival versus Xtandi in this indication.
As a result of this Phase III failure, company stock has fallen almost 80%, cutting its market cap to just $24.47 million and its share price to just $1.10.
CEO Jodie Morrison says: “We are very disappointed by this outcome. An immediate priority is to analyse the unblended study data in detail as we evaluate potential paths forward for galeterone and our pipeline.”
Tokai do try to strike a positive note in their statement, indicating that they will continue the ongoing ARMOR2 expansion in metastatic castration-resistant prostate cancer patients with acquired resistance to Xtandi, as well as a planned study in patients who rapidly progress on either Xtandi or Zytiga (abiraterone acetate).
The company is set to report its earnings on August 10. As of June 30, they had $43.9 million in cash.
Sean Murray
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