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Tokai initiates Phase III galeterone trial in patients with AR-V7 positive mCRPC

US-based Tokai Pharmaceuticals has initiated a Phase III clinical trial (ARMOR3-SV) of galeterone in patients with AR-V7 positive metastatic castration-resistant prostate cancer (mCRPC).

The ARMOR3-SV trial is being carried out for mCRPC patients whose tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor (AR) that has been associated with non-responsiveness to commonly-used oral therapies for mCRPC.

According to the company, the components of the AR-V7 clinical trial assay have been finalized and global deployment is now underway by its collaborator, Qiagen.

Tokai president and chief executive officer Jodie Morrison said: "ARMOR3-SV represents an important step forward in bringing precision medicine to patients with prostate cancer, and we are pleased with the progress made by our valued collaborator Qiagen in readying the AR-V7 clinical assay for global implementation.

"With worldwide commercial rights to galeterone, our pivotal clinical trial on track to read out by the end of 2016, and a strong financial position, Tokai is well positioned to realize its mission of bringing new therapeutic treatment options to patients with prostate cancer."

The trial will compare galeterone to Xtandi (enzalutamide) in 148 mCRPC treatment-naïve patients whose prostate tumors express the AR-V7 splice variant.

The company noted that these truncated ARs are missing the C-terminal end of the AR that contains the ligand-binding domain, which is called C-terminal loss.

The trial will employ a precision medicine approach for selection of patients with the AR-V7 splice variant by using an AR-V7 clinical trial assay optimized for global use by Qiagen.

The design of the Phase III ARMOR3-SV trial is aligned with feedback obtained from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The trial has been initiated at more than 15 sites in the US, with site initiations in Canada and the UK expected later this month.

Additional study centers across North America, Western Europe and Australia are expected to join in the coming months.

The company said that top-line data from the Phase III ARMOR3-SV trial is expected to be available by the end of next year.