In this proposal, Privo describes its research and development plans in order to obtain Food and Drug Administration (FDA) Investigational New Drug (IND) status for its localized nanoparticle based chemotherapy wafer for safely treating oral cancer. According to the Oral Cancer Foundation, over 43,250 Americans will be diagnosed with oral and pharyngeal cancer this year, causing over 8,000 deaths, roughly one person every hour. In 2011, over 640,000 new oral cancer cases were diagnosed worldwide, and only half will live more than 5 years after initial diagnosis. By 2020, the annual worldwide incidence is predicted to increase to over 840,000, a 30% rise, and the annual mortality to increase to nearly 480,000, approximately a 37% increase. Currently, cisplatin is at the forefront of platinum based chemotherapeutics for treating oral cancer. However, its successful administration is frequently hindered by its significant systemic toxicity as a result of traditional bolus systemic intravenous (IV) administration. Privo Technologies is a company with roots in MIT's Langer Lab which has developed a nanoengineered ChemoThin Wafer (CTW(c)) for topical and local delivery of chemotherapy agent cisplatin (CIS) to oral cancer tumors. This technology has been awarded more than $3 million in non- dilutive funding, including a recent approval of $2.3 million funding from the National Cancer Institute (NCI) for its IND enabling preclinical studies. Privo's treatmen has been shown to be safer and more effective than the gold standard intravenous (IV) cisplatin. CTW(c) is easy to administer, and takes only 1 hour to complete the application. It has caused complete tumor regression in animals after 6 treatments. In this proposal, Privo requests funding from NIDCR which, when combined with the NCI funding, will provide Privo the adequate resources to obtain its FDA Investigational New Drug (IND) status. This proposal includes performing the Chemistry Manufacturing and Control (CMC) process required prior to clinical trials, developing required assays including the identity assay, potency assay of the active pharmaceutical ingredient (cisplatin), and purity assay, the establishment of GMP manufacturing, and sourcing pharmaceutical grade raw materials. Privo believes that its CTW(c) aligns closely with the aims of NIDCR in providing a safer, more effective, and less costly treatment for oral cancer.
Privo's nano-engineered topical ChemoThin Wafer (CTW(c)) treatment will deliver highly concentrated cisplatin topically and locally in a targeted manner directly to oral cancer tumors. In three sets of in-vivo studies, CTW(c) has proven to be more effective and significantly safer than the current gold standard intravenous chemotherapy. It is cost effective, simple to administer and the procedure takes only one hour. Complete tumor regression has been achieved with six doses of CTW(c) with no recurrence within 9 months post treatment. Privo aims to obtain the FDA's Investigational New Drug (IND) status at the completion of this proposal.