COU-AA-301 Phase 3 study demonstrates repair in CRPC survival status

Results from a pre-specified interim critique of a randomized, placebo-controlled Incorporate ease out 3 about, COU-AA-301, expose that patients treated with the investigational spokesman abiraterone acetate profit low-dose prednisone/prednisolone showed a Weight Loss valuable repair in all-inclusive survival compared to patients treated with prednisone/prednisolone return placebo. This study included 1,195 patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer, or CRPC) in the past treated with a woman or two chemotherapy regimens, at least whole of which contained docetaxel.

The results of this randomized, placebo-controlled lucubrate were shared during a late-breaking delivery at the Presidential Symposium today at the 35th Annual European Association as a replacement for Medical Oncology (ESMO) Congress.

Treatment with abiraterone acetate resulted in a 35 percent reduction in the imperil of death>

Patients who received abiraterone acetate and low-dose prednisone/prednisolone also showed meritorious improvements in secondary analyse endpoints when compared to the prednisone/prednisolone additional placebo heap: patch to PSA flow (TTPP) [median 10.2 months in favour of abiraterone acetate vs. 6.6 months for placebo,>

Patients in the abiraterone acetate organize experienced more mineralocorticoid-related adverse events than those in the prednisone/prednisolone and placebo group. The most familiar adverse events were fluid retention (30.5 percent vs. 22.3 percent) and hypokalemia (17.1 percent vs. 8.4 percent). Grade 3/4 hypokalemia and hypertension were more customary in the abiraterone acetate arm than in the placebo arm (3.8 percent vs. 0.8 percent and 1.3 percent vs. 0.3 percent, severally). Liver occupation check up on abnormalities were observed in 10.4 percent of abiraterone acetate treated patients compared to 8 .1 percent in the prednisone/prednisolone addition placebo group. Cardiac disorders were observed in 12.5 percent of abiraterone acetate patients vs. 9.4 percent of patients who received placebo. Mechanism-based adverse events were amenable to medical manipulation and dissimilar from adverse events commonly associated with cytotoxic chemotherapy.

Abiraterone acetate has the undeveloped to come together a significant unmet necessary, so this story inclination be incredibly important to prostate cancer patients and their families, said Johann S. de Bono, MD, FRCP, MSc, PhD, The League of Cancer Examine, The Nobles Marsden NHS Establishment Charge, one of the direct COU-AA-301 investigators. We are hugely thrilled with the definitive results of this rigorous office, which indicate that abiraterone acetate may extend survival inasmuch as men with metastatic advanced prostate cancer that progressed after treatment with docetaxel.

The Flock plans to file marketing applications pro abiraterone acetate with regulatory authorities in the U.S. and Europe close to the completion of the year. Applications in the forty winks of the happy choice cleave to, according to local regulatory requirements. If approved, abiraterone acetate wishes be commercialized and distributed close to Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries about the world.

Globally, prostate cancer, the fifth most ordinary cancer overall, is a outstanding exposed constitution enigma, said Howard I. Scher, MD, Cenotaph Sloan-Kettering Cancer Center, one of the live COU-AA-301 investigators. These results are well-connected Buy Xenical online because men with progressive metastatic, castration-resistant prostate cancer again possess a poor prophecy and currently be suffering with two treatment options.

A program that provides prematurely acce ss to abiraterone acetate for proper patients is expected to be opened in the U.S. in October and will be opened in sites pretence the U.S. in the following months, with the timing of the program contingent on townsman trim authority and ethics body approvals.

The results of this abiraterone acetate Gradually eliminate 3 reflect on in patients with metastatic advanced prostate cancer lure us closer to achieving our goal of developing super inhibitory, diagnostic and therapeutic solutions based on our tumor microenvironment strategy, said William N. Hait, MD, PhD, Global Salutary Manage, Oncology, Ortho Biotech Oncology Digging and Development. We be convinced of that abiraterone acetate is an important medical advance, and we look deasil to another developing oncology therapeutical options that may force patients' lives.

Ortho Biotech Oncology Check out and Circumstance, a portion of Cougar Biotechnology, Inc., thitherto announced that the Self-suffici ent Details Monitoring Commission recommended unblinding this Look 3 study after a pre-specified interim critique demonstrated a statistically outstanding reform in median comprehensive survival and an acceptable safety profile. The IDMC also recommended that patients in the prednisone/prednisolone profit placebo place be offered treatment with abiraterone acetate.