ZIOPHARM Oncology (ZIOP) Updates on PICASSO 3, Sees PFS Being Achieved in H212
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ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced an update on its PICASSO 3 trial, a randomized, double-blinded, placebo-controlled Phase 3 trial of palifosfamide for the treatment of metastatic soft tissue sarcoma in the front-line setting.
Rigorous patient enrollment and evaluation is currently ongoing at over 150 centers worldwide, with target enrollment of 424 patients now approaching 90% completion. This includes central review of pathology and radiology prior to randomization, placebo-control and double blinding throughout the conduct of the study. Based on current projections, the Company expects data for progression-free survival (PFS), the study's primary endpoint for accelerated approval, in the second half of 2012. The outcome of the recent Oncologic Drugs Advisory Committee (ODAC) meeting, held on March 20, 2012 by the U.S. Food and Drug Administration to review the clinical benefit of two candidates for second-line treatment of sarcoma, supports the Company's belief that the PICASSO 3 study is well designed and positioned in the rapidly evolving therapeutic landscape for the treatment of soft tissue sarcoma.
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Rigorous patient enrollment and evaluation is currently ongoing at over 150 centers worldwide, with target enrollment of 424 patients now approaching 90% completion. This includes central review of pathology and radiology prior to randomization, placebo-control and double blinding throughout the conduct of the study. Based on current projections, the Company expects data for progression-free survival (PFS), the study's primary endpoint for accelerated approval, in the second half of 2012. The outcome of the recent Oncologic Drugs Advisory Committee (ODAC) meeting, held on March 20, 2012 by the U.S. Food and Drug Administration to review the clinical benefit of two candidates for second-line treatment of sarcoma, supports the Company's belief that the PICASSO 3 study is well designed and positioned in the rapidly evolving therapeutic landscape for the treatment of soft tissue sarcoma.
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