The long term goal of this research is to reduce toxicity and graft rejection due to dosing problems with the calcineurin inhibitors by developing a Plexis subcutaneous injectable formulation of a calcineurin inhibitor.

Substantial inter-and intra-patient variability of the calcineurin inhibitors means that even frequent drug monitoring cannot eradicate rejection because of sub-therapeutic troughs or toxicity due to higher than necessary peak levels. In addition, non-adherence with the daily oral dosing regimen is a major cause of graft failure, especially in adolescent patients.  Pharmacokinetic modeling suggests that periodic subcutaneous dosing can reduce or eliminate many of these problems.

More than 50,000 transplants requiring immunosupression are performed annually in the largest 7 markets (US, Japan, Germany, Britain, Canada, France and Italy), and the market for immunosuppressive drugs is estimated at $2.9 billion annually. We recognize that a sustained release formulation of cyclosporine or tacrolimus will only ever be used in a small percentage of patients. However, each 1% of this market represents $29 million in market opportunity.