On October 14, 2014 Sorrento Therapeutics reported positive results from recently analyzed pharmacokinetic (PK) data from the first eight (8) patients enrolled in its ongoing TRIBECA (TRIal establishing BE between Cynviloq and Albumin-bound paclitaxel) registrational trial (Filing 8-K , Sorrento Therapeutics, OCT 14, 2014, View Source [SID:1234500829]). The data from these patients supports earlier completion of the study with the aim of seeking to establish bioequivalence (BE) to albumin-bound paclitaxel to obtain Food and Drug Administration (FDA) marketing approval for Cynviloq (paclitaxel polymeric micelle for injection).
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Sorrento amended the current BE cross-over design protocol of the TRIBECA study to un-blind the first 8 patients to reassess the sample size of 100 patients estimated from simulation of historical PK data. Based on the cross-over data and the analyses of relevant paclitaxel plasma PK data performed by two independent PK consulting groups, the success of the BE approach for seeking approval of Cynviloq remains subject to FDA review and discussion. Sorrento does not plan to un-blind additional patient data. Current sample size point estimates suggest that the enrollment target for the current study can be reduced to nearly half of the original target.
"We are pleased that the favorable PK data from actual patients treated have thus far exceeded our expectations", said Henry Ji, Ph.D., President and Chief Executive Officer of Sorrento. "Guided by these promising data, Sorrento plans to reduce the TRIBECA patient sample size to accelerate filing for FDA approval."