MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

Inclusion Criteria:

• Histologically confirmed HNSCC (The American joint committee on cancer [AJCC] 8thedition, Stage II, III, IVA, or IVB), involving either the oral cavity ororopharynx, or HPV-positive Stage I oropharyngeal cancer.

• Treatment plan to receive a continuous course of intensity-modulated radiationtherapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractionsof 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60to 72 Gy, α/β ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher.

• CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapyadministered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks.

• Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less

• Serum pregnancy test negative for women of childbearing potential (woman ofchildbearing potential [WOCBP]

Exclusion Criteria:

• Patients who have active mucositis at screening.

• Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy duringthe study.

• Tumor of the lips, sinuses, or salivary glands or unknown primary tumors.

• Metastatic disease (M1) Stage.

• Known history of severe vascular toxicity or allergies or intolerance to cisplatinand similar platinum-containing compounds.

• Any clinically significant and/or active infection, other systemic illness orcondition (other than HNSCC) that would preclude them from participating in thestudy in the opinion of the Investigator.

• Prior resective surgery (4 weeks or less than 4 weeks from receiving surgery torandomization) for primary tumor under treatment for HNSCC.