, 15, and 29, was 24%, 56%, 70%, 73% and 94%, respectively.
PlenaxisTM - Clinical Experience
The use of PlenaxisTM (given in the same dose and schedule as above) was also studied in 81 patients with advanced symptomatic prostate cancer who were at risk for clinical exacerbation ("clinical flare") if treated with an LHRH agonist in an open-label, multicenter, uncontrolled, single-arm study. A detailed description of the results of this clinical study was recently published in the November 2003 issue of Urology (Koch M, Steidle C, Brosman S, Centeno A, Gaylis F, Campion M and Garnick M. An open-label study of abarelix [PlenaxisTM] in men with symptomatic prostate cancer at risk of treatment with LHRH agonists. Urology 62:877-882, 2003).
Commenting on this recent publication and FDA approval of PlenaxisTM, Marc B. Garnick, M.D., PRAECIS' Executive Vice President and Chief Medical Officer stated, "The primary endpoint of this study was the avoidance of surgical castration at 4 and 12 weeks of treatment. No patient required surgical castration through 12 weeks of PlenaxisTM treatment, or through 40 weeks (median study duration) in a follow-up study. Specific clinical outcomes in those experiencing symptoms from advanced prostate cancer were also evaluated, although these evaluations were not the primary objective of the study. None (0) of 8 patients with vertebral or epidural metastases and without neurological symptoms developed neurological symptoms. Ten of 13 patients with bladder outlet obstruction and a bladder drainage catheter had relief of their obstruction leading to catheter removal by 12 weeks. Eleven of 15 patients with pain due to skeletal metastases were able to reduce the potency, dose and/or frequency of narcotic analgesia at 12 weeks."
"Three of 81 patients withdrew from the study because of an immediate-onset systemic allergic reactioPage: 1 2 3 4 5 6 7 8 9 Related medicine news :1
Contact: Kevin F. McLaughlin, PRAECIS
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