Microcap Tokai ($TKAI) has had a summer to forget, but its woes got worse this week as it announced that it will stop enrollment in one trial and ax another as its future appears in jeopardy.
Specifically, the biotech will not ask for any more patients in its ARMOR2 expansion trial of experimental cancer med galeterone in metastatic castration-resistant prostate cancer (mCRPC) patients who have become resistant to treatment with Medivation/Astellas’ prostate cancer blockbuster Xtandi (enzalutamide).
On top of this, according to its SEC 8-K filing, it will: “Not proceed at this time with its planned study of galeterone in mCRPC patients who rapidly progress on either enzalutamide or [Janssen’s prostate cancer drug] Zytiga (abiraterone acetate).”
This comes a month after the Boston, MA-based company posted data showing that galeterone was likely not to best Xtandi (enzalutamide) in a Phase III trial.
In that ARMOR3-SV trial, which has now been discontinued, the biotech was looking at its drug as a first-line therapy in mCRPC patients whose prostate tumors express AR-V7. Tokai shares tumbled by about 70% on the news.
With a sense of inevitability, a week later, Tokai swung the ax to around 60% of its workforce, leaving it with just 10 full-time staffers as it looks to save money.
Tokai has one more hand to play, but it’s a weak one. “Tokai is continuing to evaluate the unblinded data from its recently discontinued ARMOR3 clinical trial comparing galeterone to enzalutamide in treatment-naïve mCRPC patients whose prostate tumors express the AR-V7 splice variant, and is assessing potential next steps in its galeterone program,” the company said in its brief SEC filing.
Tokai finished up 22% at the end of play yesterday, but was down 16% in after-hours trading and is now dangerously near penny-stock territory.
- access the release here