The purpose of our Disease Team planning grant was to develop a solid Clinical development program for our compound, LLP2A- Ale that directs mesenchymal stem cells to the bone marrow and stimulates new bone formation.
We published our scientific findings in the Journal Nature Medicine (2012 March issue). Our research team developed a clinical development program that included producing compound, performing toxicity studies, and a clinical development plan for a Phase I study. We also submitted an IND for the FDA, the FDA responded to our clinical development program and questions we raised, and we had a teleconference with the FDA CDER group on January 31st, 2012.
We have obtained sufficient information from the FDA on our IND to begin producing our compound for toxicity studies. In addition, we participated in a Stem Cell Awareness Public Forum at UC Davis in which we displayed our work with the mesenchymal stem cells to build new bone.