Salix Pharmaceuticals Backs Phase 2 Study on RELISTOR for Head and Neck Cancer

Bausch Health Companies Inc., together with its gastroenterology unit Salix Pharmaceuticals, announced their support for a Phase 2 investigator-initiated study (IIS) on RELISTOR® (methylnaltrexone bromide: MNTX) for patients with resectable head and neck squamous cell carcinoma. The study will be led by Dr. Juan P. Cata at The University of Texas MD Anderson Cancer Center, focusing on evaluating MNTX's potential as a treatment for oral cavity squamous cell carcinoma.

The trial is designed as a prospective, nonrandomized pilot study to explore the drug's efficacy when administered subcutaneously to patients both two weeks preoperatively and postoperatively. Robert Israel, M.D., Senior Vice President of Clinical and Medical Affairs at Salix, highlighted the preclinical data and clinical suggestions indicating the drug's potential activity against cancer. This investigation aims to understand MNTX's potential in neoplastic disease management.

Outcome measures include successful administration without adverse events interruption and assessments on tumor viability, proliferation and apoptosis index, objective response rate, survival rates, and patient-reported outcomes, with follow-ups every three months for the first two years.