An update on development of galeterone in the treatment of mCRPC


In a statement from Tokai Pharmaceuticals, the company has provided additional information about the clinical development of the investigational drug galeterone in treatment of metastatic, castration resistant prostate cancer (mCRPC).

According to this media release, apparently timed to coincide with the ongoing Genitourinary Cancers Symposium here in San Francisco:

  • The company now expects to complete enrollment to the ongoing Phase III ARMOR-SV trial in 2016. This trial is designed to compare outcomes from treatment with galeterone to treatment with enzalutamide in men with mCRPC and expression of the AR-V7 mutation (who appear to be highly resistant to effective treatment with either enzalutamide or abiraterone acetate).
  • The company also expects to announce the preliminary results of the ARMOR-SV trial by some time in 2017.
  • The company is initiating two additional, smaller trials of the use of galeterone in the management of carefully selected patients with mCRPC (see the media release for details).

Should the results of the ARMOR-SV trial be positive, we might be able to expect approval of galeterone in the treatment of men with mCRPC and expression of the AR-V7 mutation by some time in 2018 (or perhaps earlier if the data are very strong).

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