Independent data monitoring committee recommends continuation of RINGSIDE phase II/III study of AL 102 in desmoid tumors.- Ayala Pharma
Ayala Pharmaceuticals announced that the Independent Data Monitoring Committee (IDMC) for its Phase II/III RINGSIDE study evaluating investigational new drug AL 102 in desmoid tumors conducted a prespecified periodic review of data from the study and recommended that the study continue without modifications.
Phase III of RINGSIDE is a double-blind, placebo-controlled, clinical trial enrolling up to 156 patients with progressive disease, comparing AL102 at 1.2 mg once-daily to placebo. The primary endpoint for Phase III is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), tumor volume reduction, and patient-reported Quality of Life (QOL) measures.
“We thank the IDMC members for their work and guidance and are pleased with their recommendation to continue RINGSIDE with no changes,” said Ken Berlin, President and CEO of Ayala. “This recommendation was made based on the analysis of recently updated data from the Phase II segment of RINGSIDE. We have commenced enrollment in the Phase III segment of RINGSIDE on a worldwide basis. In addition, patients from Phase II have the opportunity to continue treatment in the open label extension in Phase III. We believe that once-daily AL 102 has best-in-class potential and are excited about its potential use in desmoid tumors. If approved, we believe it will be a valuable addition to the future therapeutic armamentarium in this underserved indication..
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