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January 6, 2016

FDA grants fast-track status for Innocrin’s seviteronel to treat metastatic CRPC

The US Food and Drug Administration (FDA) has granted fast-track designation for Innocrin Pharmaceuticals' seviteronel (VT-464) to treat patients with metastatic castrate-resistant prostate cancer (CRPC).

The US Food and Drug Administration (FDA) has granted fast-track designation for Innocrin Pharmaceuticals’ seviteronel (VT-464) to treat patients with metastatic castrate-resistant prostate cancer (CRPC).

Innocrin is focused on developing small-molecule CYP17 lyase-selective inhibitors to treat hormonally-dependent breast and prostate cancers that are resistant to traditional anti-hormonal therapy.

Seviteronel is a once-daily oral therapeutic given without prednisone. It selectively inhibits CYP17 lyase, a target of abiraterone, and has blocking effects on the androgen receptor (AR), the target of enzalutamide.

"We believe that these presentations will raise the profile of a new agent that could make a tremendous impact for patients with very few other treatment options."

The company noted that preclinical and clinical trials have showed that some patients resistant to abiraterone or enzalutamide will respond to seviteronel treatment.

Innocrin CEO William Moore said: "We believe that the award of fast-track designation represents important recognition by FDA of seviteronel’s potential to address a significant unmet need in the treatment of patients with CRPC.

"In addition, we are pleased to present new seviteronel clinical results in multiple sessions at ASCO GU. We believe that these presentations will raise the profile of a new agent that could make a tremendous impact for patients with very few other treatment options."

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According to the company, resistance following treatment with abiraterone, enzalutamide or both represents a major unmet medical need due to the widespread and growing use of these new agents, and to the high cross-resistance of cancers in patients exposed to these agents to approved drugs.

In addition to its AR antagonist activity, seviteronel may also have significant potential to treat breast cancer due to its selective inhibition of CYP17 lyase, which results in the depletion of both androgens and estrogens.

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