Key milestones in our preclinical and clinical project plan to clinical proof (Phase 2a) are:
- Synthesis and characterization of the modified glucocorticoid in the laboratories of WindRose Analytica, Inc. (Camarillo, CA);
- Dose range-finding and distribution studies in the zoster-induced model of allodynia;
- Completion of preclinical studies, including toxicology, additional distribution studies using radio-labeled study material and validation in one or several other localized models of pain;
- Prepare Investigational New Drug (IND) dossier; and
- Clinical studies involving dose escalation studies in Phase 1a and Phase 1b, followed by clinical proof studies in Phase 2a and 2b.