Arno starts Phase II testing of onapristone in men with CRPC

According to a media release issued yesterday, Arno Therapeutics has  moved its investigational drug onapristone into the Phase II part of its initial Phase I/II clinical trial in the treatment of very late stage prostate cancer.

Onapristone is being tested to see if it shows initial signs of clinical activity and necessary safety in the management of castration-resistant prostate cancer (CRPC) in men who have progressed after treatment with either abiraterone acetate (Zytiga) or enzalutamide (Xtandi) — or presumably both of these drugs.

The current, Phase II, portion of the initial trial will be carried out at multiple clinical sites in the United Kingdom only. It is expected to enroll about 75 patients. Arno will evaluate the clinical use of onapristone in combination with abiraterone acetate in men with CRPC, and will also study the effectiveness and safety of  onapristone as a single agent. The currently recommended dose of onapristone as a single agent in this trial is a 50 mg extended release tablet, taken twice a day. Onapristone is an anti-progestin that may have clinical benefit in inhibiting tumor growth in certain patients with CRPC. It has previously been shown to have anti-tumor activity in the management of breast cancer.

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