Our lead candidate is a formulation of a commonly used, highly potent but toxic chemotherapeutic drug delivered through our Thermosomes. Its toxicity profile – both through its maximum tolerated dose (MTD) and its maximum cumulative tolerable dose – limits its therapeutic usage. A 10-15x higher local drug concentration and less systemic side effects could significantly improve its therapeutic and safety window and increase response rates in patients with locally-advanced solid tumors, i.e., where the primary tumor is the main focus of treatment.
In several pre-clinical proof-of-concept studies in different animal species with both cell-line grown tumors and naturally grown tumors, our lead candidate has shown dramatic efficacy improvements while simultaneously reducing systemic and local side effects as compared to conventional systemic drug application. Based on this promising pre-clinical proof-of-concept, our lead candidate is currently within the final pre-clinical development steps. Thereafter, we plan to evolve our lead candidate into clinical testing in patients with certain locally-advanced solid tumors (details on indications to follow).
Beside our lead candidate, several proof-of-concept studies are being conducted with other active pharmaceutical ingredients (APIs) including formulation studies, in vitro characterization and/or initial pre-clinical testing. In addition, co-encapsulation and release of commonly-used contrast agents were found to be feasible, which may be clinically used for image-guided drug delivery applications (theranostics). Selective APIs may qualify for clinical development through us or partners at later points in time. For further details on our development programs, please contact us.