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Replies to post #44463 on NorthWest Biotherapeutics Inc (NWBO)
Pyrrhonian
11/07/15 10:10 AM
#44468 RE: notbrad #44463
And what you are leaving out is that the total enrollment for both of DNDN's 2 trials was less than 348. --notbrad
14.3 Study D9902A Study D9902A was a random ized, double blind, placebo- controlled, multicenter trial in patients with asymptomatic metastatic castrate resistan t prostate cancer. A total of 98 patients were randomized 2:1 to receive PROVENGE ® (active treatment, n=65) or placebo (control, n=33). Study D9902A was identical in design to Study D9901. Baseline demographics and disease characteris tics were generally well balanced between the treatment groups. Several prognosti c factors, including the percen tage of patients with more than 10 bone metastases, and median values fo r PSA, LDH and alkaline phosphatase favored the placebo arm. Of the 33 patients randomized to placebo, 22 patients (66.7%) crossed over to receive antigen loaded (PAP-GM-CSF) APCs pr epared from autologous APC precursors that had been cryopreserved at the time of placebo ge neration as part of the salvage study. Following disease progression, 38.6% of patients in the PROVENGE ® arm and 34.4% of patients in the placebo arm received subsequent treatment with docetaxel. There was no significant delay in time to disease progression (HR = 0.921 [95% CI: 0.588, 1.443]; P = 0.719, log rank) and no significant difference in overall survival for patients treated with PROVENGE ® compared to placebo (HR = 0.786 [95% CI: 0.484, 1.278]; P = 0.331, log rank).