Project Grant R44CA272095

CLINICAL STUDIES FOR IMPROVING SURVIVAL RATES FOR ORAL CANCER PATIENTS IN LOW RESOURCE SETTINGS - PROJECT SUMMARY ORAL CANCER (OC) IS AN UNDERSERVED DISEASE, WHICH IS OFTEN OVERLOOKED BY THE MEDICAL COMMUNITY. YET IT IS THE 6TH MOST COMMON AND DEADLIEST CANCER IN THE WORLD. ACCORDING TO THE ORAL CANCER FOUNDATION, OVER 90% OF ALL ORAL CANCERS ARE ORAL SQUAMOUS CELL CARCINOMA (OSCC) - A COMMON SUBSET OF HEAD AND NECK CANCERS. OC CLAIMS THE LIFE OF ONE AMERICAN EVERY HOUR OF EACH DAY. ADDITIONALLY, IT IS ON THE RISE DUE TO THE INCREASING PREVALENCE OF ORAL HUMAN PAPILLOMA VIRUS (HPV). OVERALL, OC HAS A 60% SURVIVAL RATE AFTER 5-YEAR REMISSION TARGET, WITH RECURRENCE BEING AN IMPORTANT PROGNOSTIC FACTOR. DATA SHOWS A HIGH CORRELATION BETWEEN OC RISKS AND LOW SOCIOECONOMIC, AS WELL AS RISK FACTORS RELATED TO LIFESTYLE. EVEN IN THE CLINICAL SETTINGS OF INDUSTRIALIZED NATIONS, SUCH AS THE UNITED STATES (US), MANY PATIENTS RECEIVE SUBOPTIMAL CARE FOR OSCC DUE TO LIMITED RESOURCES. ALTHOUGH TARGETED AGENTS (I.E., TYROSINE KINASE INHIBITORS) AND IMMUNOTHERAPY (I.E., CHECKPOINT INHIBITORS) HAVE SHOWN PROMISE IN MULTIPLE SOLID TUMOR TYPES, THEIR APPLICABILITY IN THE SETTING OF ADVANCED OSCC REMAINS QUESTIONABLE. UNPREDICTABLE SIDE EFFECTS, COMPLICATIONS, AND (ESPECIALLY) HIGH COST LIMIT THEIR US USE IN LOW RESOURCE SETTINGS AND IN LOW/MID-INCOME COUNTRIES (LMICS). SURVIVAL IN PATIENTS WITH ADVANCED OSCC IS DRIVEN PRIMARILY BY LOCOREGIONAL TREATMENT FAILURE/RECURRENCE (I.E., PRIMARY SITE OR CERVICAL NODAL BASINS). ESCALATION OF CONVENTIONAL TREATMENT REGIMENS, SUCH AS SURGERY, RADIATION, AND SYSTEMIC CHEMOTHERAPY IS NOT FEASIBLE DUE TO DOSE-LIMITING TOXICITIES. AS A RESULT OF THESE CONVERGING FACTORS, THERE IS A NEED FOR NOVEL TREATMENTS THAT CAN AUGMENT EXISTING MODALITIES, WHILE IMPROVING LOCOREGIONAL CONTROL WITHOUT TOXICITIES. TO ADDRESS THIS NEED, PRIVO HAS DEVELOPED THE PRV211 INTRAOPERATIVE PRODUCT (PRV211), A NANO-ENGINEERED HYDROGEL THAT, IMMEDIATELY AFTER TUMOR RESECTION OR DEBULKING, CAN BE APPLIED DIRECTLY ONTO THE TUMOR BED. PRV211, RETAINS HIGH CONCENTRATION OF IMMUNO/CHEMOTHERAPY NANOPARTICLES, LOCALLY IN TUMOR BED AND REGIONAL LYMPH NODES TO TREAT THE LOCOREGIONAL DISEASE AND REDUCE TUMOR RECURRENCE.