Year 1

One of the early goals for this project is the successful development and clinical grade manufacturing of the drug LLP2A-Alendronate (LLP2A-Ale). We are pleased that we now have a robust stability indicating method that has been transferred for use in drug product development. We are currently working with our collaborators on stability maintenance and monitoring of the compound.

At the annual CIRM advisory committee review in late October 2013, the reviewers liked the “hybrid” compound. However, they also felt that the project would benefit from additional preclinical studies to compare two treatments for osteoporosis that are currently available, alendronate and PTH. Therefore, based on the advisory committee’s comments, we will conduct further studies that confirm and support our original hypotheses. We are looking forward to beginning clinical trials soon after those studies are completed.