According to the Oral Cancer (OC) Foundation, oral and pharyngeal cancer will cause 8,000 deaths this year in the US, 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 resut of traditional bolus systemic intravenous (IV) doses. In this proposal entitled "Fast-track: IND enabling studies for Oral Cancer", the critical path is performing the studies required by the FDA to successfully achieve the the IND status for safety trials. Privo's specific aims for phase I focs on conducting in-vivo studies to further fine tune the dosing of Privo's lead optimized formulation for its ChemoThin Wafer (CTW(c)). For the Phase II of this project, the focus is on conducting IND enabling studies to prepare Privo for human safety trial. Privo's CTW(c) contains anticancer chemotherapy agent; cisplatin which is the gold standard chemotherapy drug for oral cancer. It is designed and optimized for local and topical treatment of OC, thus replacing injection, increasing the drug's efficacy and significantly reducing its systemic toxicity. The CTW(c) 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 5-year survival of patients 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 CTW(c) delivery platform has the opportunity to considerably reduce the morbidity and mortality rate of this devastating cancer. The ultimate objective of Privo Technologies is to develop and commercialize effective, safe and convenient chemotherapy treatments accessible to many patients.
Public Health Relevance Statement: Public Health Relevance: SBIR R43/R44 application entitled "Fast-Track: IND enabling studies for Oral Cancer" Project Narrative Privo's nano-engineered topical ChemoThin Wafer (CTW(c)) treatment has the potential to deliver a very high concentration of the chemotherapy drug while significantly limiting its toxicity. It is mainly intended for topical and local treatmet of pre-malignant and malignant oral cancer tumors that have not yet metastasized to distant organs. This CTW(c) 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.
Project Terms: 9,10-Dimethyl-1,2-benzanthracene; Allografting; Animals; Applications Grants; Area; base; Biodistribution; Biotechnology; Bolus Infusion; cancer site; cancer surgery; cancer type; carcinogenicity; Cessation of life; chemotherapy; Chronic Disease; Cisplatin; Clinical; Clinical Trials; Clinical Trials Design; controlled release; Critical Pathways; Cyclic GMP; Data; design; Development; Distant; Doctor of Philosophy; Documentation; Dose; Drug Delivery Systems; drug efficacy; Drug Formulations; Drug Kinetics; Early Diagnosis; efficacy evaluation; Encapsulated; Ensure; Entrepreneurship; experience; FDA approved; Feasibility Studies; Foundations; Funding; Goals; Gold; Grant; Hamsters; Hour; Housing; Human; improved; in vivo; Injection of therapeutic agent; innovation; Intravenous; Kidney; Killings; Lead; Lesion; Malignant - descriptor; malignant mouth neoplasm; Malignant neoplasm of pharynx; Malignant Neoplasms; manufacturing process; manufacturing scale-up; meetings; Modeling; Monitor; Morbidity - disease rate; Mortality Vital Statistics; Mus; nano; nanoencapsulated; nanoengineering; Nanotechnology; Neoplasm Metastasis; novel; oncology; Organ; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Phase; Platinum; preclinical study; Premalignant; Preparation; Production; programs; public health relevance; Research; Safety; scale up; skills; Small Business Innovation Research Grant; Solid Neoplasm; Squamous cell carcinoma; Staging; Survival Rate; Techniques; Technology; Time; TimeLine; Toxic effect; Treatment Efficacy; tumor; whole animal imaging; Work
