Formulation and testing of PLGA-DS as an anti-cancer therapy for FDA and EMA new drug application

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Due to the cost ($1.5 billion), time (15 years) and high failure rate (up to 95%) of novel drug development from new compounds, there is a global trend towards the repositioning of known drugs for the treatment of cancer. We have demonstrated that Disulfiram (DS), a long-established anti-alcoholism drug, possesses excellent anticancer activity with low toxicity to normal cells. However, the effectiveness of DS as a cancer treatment has previously been limited by its bio-instability (~4 min half-life in the bloodstream). We have demonstrated that we can substantially improve the half-life of DS in the bloodstream by encapsulating it in certain nano-particles. Furthermore, we have conducted both in vitro and in vivo trials in a wide range of cancer types (based upon laboratory scale encapsulated DS product) that have produced encouraging results. In order to translate our laboratory results into cancer clinic, we propose to set up a collaborative study with Suzhou Bank Valley Ltd in Jiangsu province, China. In this project, Suzhou Bank Valley Ltd will develop nano-encapsulated DS at GMP quality and transport it to Disulfican Ltd. We will use laboratory facilities in the UK (the University of Wolverhampton and elsewhere) to examine the in vitro and in vivo anticancer activity of the newly developed nano-DS in animal cancer models. The goal of this proposal is to verify the anticancer efficacy of the GMP qualified nano-DS and provide preclinical data prior to scaling up manufacturing and embarking upon phase I clinical trials.