Our drug screening platform identifies unique drugs that target a variety of critical signaling pathways in cancer stem cells. The activity of newly discovered drugs are confirmed using multiple independent assays to ensure our candidates are novel, chemically distinct drugs that have real, potent, and reproducible activity.

Our best potential drug candidates are subjected to extensive in vitro testing, drug stability, and in vivo pharmacokinetic analyses. Candidates with the most promising chemical properties, stability, and activity are advanced to maximum tolerated dose and mouse xenograft models to test efficacy.

Remedy Plan’s drug optimization program is designed to make targeted improvements in our lead drug candidates nominated for Phase I clinical trials. After designing and synthesizing hundreds of variants of a lead drug, each compound is subjected to a series of tests (activity, differentiation, in vitro cancer cell growth, toxicity, ADME, pharmacokinetics, maximum tolerated dose, and in vivo efficacy), with only the top candidates progressing to the next stage.

Targeted chemical modifications will improve solubility and pharmacokinetics and expand our understanding of structure-activity relationships.

IND-enabling studies follow FDA guidelines for GMP (good drug manufacture) practices and GLP (good laboratory practices) toxicity studies. Each lead candidate’s IND application will include descriptions of delivery, reconstitution, practicality dosage form, safety profile, index, pharmacology regulatory path, human and clinical proof-of-concept (HPOC/CPOC) plan, and GMP quality stability.

The primary aim of Phase I clinical trial is to evaluate the safety profile of our drug candidate for the treatment of patients with different oncological malignancies