Supportive Clinical Trial Tasks for Nanotechnology-Based Treatment of Oral Cancer

Preceding Award: NCI Award 1R44CA192875-02 Project Summary: According to the Oral Cancer Foundation, about 50,000 people in the US will be newly diagnosed with oral cancer (OC) in 2017, causing 9,700 deaths[1]. OC is a severely neglected orphan disease with a lack of significant treatment advances in 4 decades[1]. Historically, OC has been present in heavy smokers and drinkers. However, more recently OC has also become more prevalent in younger people due to an increase in cancer- causing human papillomavirus (HPV) spread through oral sex[1]. About 64% of patients die within the first 5 years of diagnosis. The survival rate remains surprisingly low despite its accessibility and lack of metastasis. Survivors must manage devastating life long side effects of treatments which can lead to permanent psychological and physical damage. Oral cancer has either the highest suicide rate of all cancers or among the top 3 suicide rates of all cancers (depending on the source) due to permanent physical disabilities resulting from treatment. These include permanent speech impairment, an inability to swallow, and/or the loss of the jawbone due to the surgical removal of the tongue and other oral tissue. The long term costs associated with the treatment and these disabilities can range from $100,000-$250,000, resulting in oral cancer persisting as one of the most expensive of all cancers to treat. Despite these realities, oral cancer remains underserved and remains on the rise in incidence both within the US and worldwide. To address this unmet need, Privo Technologies has developed a topical chemotherapy patch, the ChemoThin Wafer (CTW) that is applied directly to the tumor. CTW consists of a mucoadhesive polymeric patch with embedded cisplatin-loaded nanoparticles and a non-permeable backing that facilitates unidirectional drug release, prevents drug loss, and masks taste. Cisplatin is recognized as the gold standard chemotherapeutic agent for treating oral cancer. However, cisplatin’s efficacy is often hindered by significant systemic toxicity resulting from traditional systemic intravenous (IV) administration. The cisplatin-loaded nanoparticles in the CTW have optimized size, charge, and permeation parameters to ensure that cisplatin is locally retained within the tumor tissue and not exposed to systemic bodily circulation. Privo has performed 12 sets of in vivo studies in numerous species of animals to examine the safety and efficacy of CTW. In all cases, CTW has shown robust antitumor effect and negligible local or systemic toxicities. The goal of this proposal is to support the successful completion of Privo’s Phase 2 clinical trial. Privo is confident that its team of expert scientists, business leaders, and collaborators can execute its defined aims with milestones and deliverables.R44 SBIR RFA-CA-17-024 application entitled “Supportive Clinical Trial Tasks for Nanotechnology- Based Treatment of Oral Cancer” Project Narrative Privo’s Nanotechnology-Engineered ChemoThinWafer (CTW) delivers and retains high concentration of cisplatin directly in the tumor. CTW’s safety and efficacy has been proven through multiple sets of preclinical studies. Complete tumor regression has been shown with this treatment, and there has been no recurrence for 24 months post-treatment. The treatment has been shown to be significantly safer and more effective than the standard of care chemotherapy. The CTW administration does not require any specialization/training and takes less than one hour. With the funding from this proposal, Privo will conduct its Phase 2 clinical trial.