- Tokai Pharmaceuticals will abandon a clinical study testing the efficacy of its lead drug candidate galeterone, which was in development for use in men with treatment-naïve metastatic castration-resistant prostrate cancer (mCRPC) whose tumors express a certain mutation, the company said Tuesday. Tokai stock dropped sharply after the news was announced Tuesday.
- Tokai discontinued the study after a data monitoring committee determined galeterone would probably not meet its primary endpoint. The trial was designed to compare the efficacy of galeterone, an oral small-molecule drug, versus Medivation's Xtandi in increasing progression-free survival.
- However, the company plans to continue testing galeterone in men whose mCRPC is resistant to Xtandi. In addition, researchers will evaluate the drug's efficacy in mCRPC patients whose cancer had progressed after treatment with either Xtandi or Johson & Johnson's Zytiga.
Tokai had hoped its focus on the AR-V7 mutation would yield benefits and set galeterone apart from other drugs. The trial was the first to focus on men with AR-V7 positive mCRPC.
“We are very disappointed by this outcome, said Jodie Morrison, President and Chief Executive Officer of Tokai. "An immediate priority is to analyze the unblinded study data in detail as we evaluate potential paths forward for galeterone and our pipeline."
Over 180,000 men in the U.S. develop prostrate cancer each year. And while the cancer has a high survival rate, the American Cancer Society estimates over 26,000 men will die from the disease. Many of the deaths occur after the patients develop resistance to treatment, so companies like Tokai are attempting to design drugs to meet that gap.
Medivation has attracted a number of suitors (most prominently Sanofi) due to the success of its prostate cancer drug Xtandi, which hit $1.9 billion in sales last year. Medivation co-markets the drug with the Japanese company Astellas. As a comparison, Johnson & Johnson's Zytiga brought in $2.2 billion in 2015,
But Tokai plans to battle on. As with other treatments, patients can develop resistance to Xtandi and Zytiga, and Tokai aims to study galeterone as a back-up option to those drugs.
The clock is ticking on Tokai's financial resources, however. The company said it had about $44 million in cash and equivalents as of June 30. That won't last long it it keeps burning through cash - Tokai spent roughly $10 million in the first three months of the year.