We are focussed on mesothelioma because this condition is an 'orphan disease', due to its rarity and the absence of any very effective treatments. The European Medicines Agency (EMA) gives assistance with fees and procedures, in addition to market exclusivity, for therapies to address designated orphan diseases which means that the costs and timescales to get approval for clinical trials are reduced.
MM is a highly infiltrative cancer making it impossible to completely remove the tumors by surgery. Recurrence of the tumor within a year of treatment is a common problem. However, distant metastasis of MM is very rare (<2%) making it very suitable for localized chemotherapy. Previous publications from our group and others indicate that Disulfiram is a very safe drug that selectively eradicates cancer cells and resistant cancer stem cells, and spares normal cells.
We developed intraperitoneally injectable PLGA-encapsulated Disulfiram microparticles which is protected by recently-granted patents, for localized therapy of MM. The controlled slow release of Disulfiram from the PLGA microparticles maintains a consistent high local and systemic drug concentration without need of heat treatment or prolonged wash used in current chemotherapy procedures such as HIPEC.
The results from GLP animal models has confirmed the concept and Disulfican is now proceeding with completion of the preclinical package to move towards human trials.