Tokai continues to unwind clinical program
- Tokai Pharmaceuticals announced in an SEC filing that it is discontinuing the enrollment of a Phase 2 trial of galeterone in metastatic castration-resistant prostate cancer (mCRPC) patients with acquired resistance to Medivation's Xtandi (enzalutamide).
- The company has also chosen not to proceed with a clinical trial of galeterone in mCRC patients who rapidly progress on either Xtandi or Johnson & Johnson's Zytiga (abiraterone acetate).
- Tokai continues to assess the unblinded data from its Phase 3 ARMOR3 study comparing galeterone to Xtandi in patients with mCRC who have a certain mutation.
Tokai announced at the end of July that an independent data monitoring committee recommended the discontinuation of the Phase 3 ARMOR3-SV clinical trial, after it became clear that galeterone would not help patients with mCRC who had the AR-V7 mutation more than Xtandi.
The biotech was disappointed by the lack of efficacy for galeterone. Tokai began unwinding the trial at the time and promised it would evaluate other ongoing or planned clinical trials of the drug.
Just a few days after the galeterone failure announcement, Tokai cut 60% of its workforce, laying off 10 employees.
The reductions were meant to save operating expenses and expects to save about $4.2 million from the cuts. Tokai had about $43 million in cash and equivalents at the end of July.
Tokai expects to pay a charge of $1.3 million in severance during the third quarter.
The company said it will continue to "assess potential next steps for galeterone," it said in the filing.
- U.S. Securities and Exchange Commission Tokai Pharmaceuticals SEC filing
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