Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial,
initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be
conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs)
of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment
period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and
Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of
approximately 12 months to determine if there is an effect of SCV 07 on the tumor response
to ChemoRT.