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Puma Biotechnology Inc reports positive top line data from I-SPY 2 trial


Wednesday, 4 Dec 2013 04:05pm EST 

Puma Biotechnology Inc:Says top line results from the Phase II clinical trial of Puma's investigational drug PB272 (neratinib) for the neoadjuvant treatment of breast cancer (I-SPY 2 TRIAL).Says the I-SPY 2 TRIAL is a randomized Phase II clinical trial for women with newly diagnosed Stage 2 or higher breast cancer that addresses whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy.Says the primary endpoint is pathological complete response (pCR) in the breast and the lymph nodes at the time of surgery. The goal of the trial is to match investigational regimens with patient subsets on the basis of molecular characteristics that benefit from the regimen.Says The I-SPY 2 TRIAL involves an adaptive trial design based on Bayesian predictive probability that a regimen will be shown to be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial.Says the I-SPY 2 TRIAL involves an adaptive trial design based on Bayesian predictive probability that a regimen will be shown to be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial.Says regimens are dropped for futility if they show a low predictive probability of showing superiority over standard therapy in all 10 signatures. 

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65.44
0.29 +0.45%
11 Jul 2014