Salix Pharmaceuticals announces Phase 2 investigator-initiated study of RELISTOR

Bausch Health Companies and its gastroenterology business, Salix Pharmaceuticals is supporting a Phase 2 investigator-initiated study of RELISTOR in patients with resectable head and neck squamous cell carcinoma. An IIS is a study that is proposed, developed, and conducted by a qualified sponsor external to Bausch Health/Salix who assumes full responsibility for the study. The clinical study is being led by Juan P. Cata, M.D. at The University of Texas MD Anderson Cancer Center. The trial is designed to evaluate the potential of treating oral cavity squamous cell carcinoma patients with MNTX. It is a prospective, nonrandomized pilot “proof of concept” study where patients receive subcutaneous MNTX two weeks preoperatively and two weeks postoperatively.m Upon completion of the study, participants will be monitored every 3 months during the first two years. The primary endpoint is the successful administration of MNTX for two weeks preoperatively and postoperatively without interruption due to adverse events. Secondary endpoints include tumor viability, proliferation and apoptosis index, objective response rate, survival rates, and patient-reported outcomes.