Tokai stops Phase III trial of galeterone


Alas, Tokai Pharmaceuticals has announced this morning that it has been forced to discontinue the ARMOR3-SV trial of its investigational drug galeterone in the treatment of patients with castration-resistant prostate cancer (CRPC) who are expressing the AR-V7 mutation.

This is not only a major setback for the company itself. It is also, regrettably, a major setback for patients whose cancer expresses the AR-V7 mutation. Many patients and advocates had been hoping that galeterone would offer renewed hope for those who are diagnosed with the AR-V7 mutation.

According to the media release issued by Tokai this morning, the independent data monitoring committee had concluded that the ARMOR3-SV trial

will likely not succeed in meeting its primary endpoint of demonstrating an improvement in radiographic progression-free survival (rPFS) for galeterone versus enzalutamide in AR-V7 positive mCRPC.

However, the good news is that the committee did not cite any safety concerns with galeterone in the trial.

The company will be reviewing data related to the other Phase II trial that is ongoing — the ARMOR2 trial, in men who had already progressed after treatment with enzalutamide, and we shall have to wait to see whether the available data can justify the continuation of that trial. In the interim, Tokai will allow all patients currently enrolled in the ARMOR2 and ARMOR3-SV trials to continue on therapy following consultation with their physicians and study investigators.

Several other media sources (e.g., Xconomy, the Boston Globe) have already commented on the closure of this trial.

3 Responses

  1. Hopefully the Zenith ZEN00694 BET inhibitor trial may pick up some of the slack for AR-V7 positive men.

  2. I am always extremely cautious about Phase I trials like this. We don’t even know if the drug can be given successfully to humans at all until such trials are complete, let alone whether the drug is effective and safe.

  3. Bummer

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