DESCRIPTION (provided by applicant): According to the Oral Cancer (OC) Foundation, oral and pharyngeal cancer will cause 8,000 deaths this year, killing roughly one person per hour. Currently, cisplatin (CIS) is at the forefront of platinum- based chemotherapeutics for treating OC. However, its efficacy is often hindered by its significant systemic toxicity as a result of traditional bolus systemic intravenous (IV) doses. In this proposal, Privo's specific aims focus on developing and optimizing an effective and safe nano engineered drug delivery platform, i.e., chemo-wafer (CW) that reformulates a known anticancer chemotherapy agent ( e.g. cisplatin) for the local and topical treatment of OC, thus replacing injection, increasing the drug's efficacy and significantly reducing its systemic toxicity. The CW platform contains FDA approved chemotherapy drugs and generally recognized as safe (GRAS) materials. It utilizes nano-encapsulation techniques to incorporate drugs into NPs with a controlled-release design that releases chemo drugs at fully tunable and pre-determined rates. The design has the potential to deliver a highly concentrated amount of chemotherapy agents directly to the cancer tissue while minimizing toxic side effects to the surrounding healthy tissues. Part of the project is the development of a novel bilayered vehicle, CW, consisting of a NP front end and a plasticized, non-porous, non-permeable back end. It consists of a mucoadhesive material with unidirection delivery of the drug, which prevents the chemo agent from reaching the taste buds. This addresses the unpleasant taste issues, and increases patient compliance. This project can change the chemotherapy treatment of OC patients by replacing IV delivery with topical delivery of CW, significantly reducing the overall cost of OC treatment. The American Cancer Society has emphasized that oral chemotherapy is truly the wave of the future for oral cancer treatments because it offers patients distinct advantages over traditional IV. The 5- year survival of patient with OC has not significantly improved over the past several decades. Moreover, the survival rate for early detection is significantly higher than later stages (80-90% vs. 25- 35%). Therefore, for patients with pre-malignant to non-metastasized malignant OC, this reformulated nano-encapsulated CW delivery platform has the opportunity to considerably reduce the morbidity and mortality rate of this devastating cancer. The CW has the potential to be administered by the patient and in the privacy of their own homes, avoiding the inconvenience of travel to and from chemotherapy clinics and reducing healthcare cost. The ultimate objectives of Privo Technologies are to develop and commercialize an effective, safe and convenient chemotherapy treatment accessible to many OC patients.

PUBLIC HEALTH RELEVANCE: Privo's nano-engineered topical chemotherapeutics has the potential to deliver a very high concentration of the drug while significantly limiting its toxicit. It is intended for topical and local treatment of pre-malignant and malignant lesions that have not yet metastasized to distant organs. This project may also provide a necessary alternative to patients who are unable to receive conventional chemotherapy due to suffering from chronic diseases such as compromised kidney.