On January 12, 2015 Sorrento Therapeutics reported that over 80 patients randomized in the ongoing TRIBECA (TRIal establishing bioequivalence [BE] between Cynviloq and Albumin-bound paclitaxel*) registrational trial have been dosed (Filing 8-K , Sorrento Therapeutics, JAN 12, 2015, View Source [SID:1234501326]). Sorrento intends to continue enrolling all qualified patients in the current screening process and anticipates having the "last patient in" by the end of January. Patients were recruited globally from over 20 sites in USA, Eastern Europe, and Asia. The initial safety assessment from treated patients revealed no unexpected adverse events and the data is consistent with the toxicity profile reported in the literature with albumin-bound paclitaxel.
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Previously, Sorrento announced positive pharmacokinetic (PK) data from the first eight (8) patients enrolled in the TRIBECA study. Based on our reported positive data, sample size estimates suggest that only 53 patients are needed to meet regulatory guidelines for BE.
"We are pleased with the imminent completion of the TRIBECA study" said Henry Ji, Ph.D., President and Chief Executive Officer of Sorrento. "Our plan is to continue to enroll patients until the end of January to have a robust safety database of patients treated with Cynviloq (paclitaxel nanoparticle polymeric micelle) at 260 mg/m2 infused over 30-minutes. The completion of patient enrollment in January will allow us to make topline pharmacokinetic results available in March, and facilitate the planned NDA submission to the FDA seeking marketing approval for Cynviloq."