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Arno Therapeutics Advances Phase I/II Trial Evaluating Onapristone in Prostate Cancer to Phase II
Arno Therapeutics Advances Phase I/II Trial Evaluating Onapristone in Prostate Cancer to Phase II.
About this update from Arno Therapeutics Inc
[{"type":"text","content":"\n\n - Phase II to include study of onapristone in combination with abiraterone -\n FLEMINGTON, N.J., March 21, 2016 (GLOBE NEWSWIRE) -- Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of therapeutics for cancer and other life threatening diseases, today announced that it has enrolled the first patient in the second stage of its Phase I/II clinical trial evaluating onapristone in men with advanced castration-resistant prostate cancer (CRPC), after failure of abiraterone or enzalutamide. The Phase II portion of this study will evaluate onapristone in combination with Zytiga® (abiraterone acetate) in patients with CRPC.  Stage 2 of the study also includes a Phase II cohort of patients with CRPC who will receive single agent onapristone.  An independent data review committee has determined the recommended Phase 2 dose of single agent onapristone to be 50mg extended release tablets, taken twice daily.  Alex Zukiwski, MD, Chief Executive Officer of Arno Therapeutics, remarked, “Enrollment of the first patient in the Phase II portion of the trial is an important milestone as we look forward to determining the safety profile and potential antitumor activity of onapristone in combination with abiraterone, one of the most prescribed prostate cancer drugs on the market. Research shows that the progesterone receptor (PR) is moderately to highly expressed in CRPC and that progesterone can activate androgen receptor genes in prostate cancer cell lines with certain androgen receptor mutations, indicating that an anti-progestin like onapristone may have clinical benefit in inhibiting tumor growth in certain patients with CRPC. We believe the modified CRPC stage 2 protocol will enable us to more fully determine the potential benefits of onapristone in this patient population.” Onapristone is an oral, anti-progestin hormone blocker that has been shown in previous Phase II clinical trials (not sponsored by Arno) to exhibit anti-tumor activity in patients with breast cancer. In pre-clinical testing, onapristone has been shown to block the activation of the progesterone receptor (PR), which is believed to be a mechanism that inhibits the growth of activated progesterone receptor (APR) driven breast, endometrial and other, primarily gynecological tumors, in a...