Corporate Development Milestones
From its inception in mid 2008, the Company has achieved the following milestones:
- Secured an exclusive license for therapeutic applications of zirconium silicate.
- Assembled the executive management team and Board of Directors.
- Secured a small quantity of ZrSi (ZS-9) inventory from UOP.
- Outsourced initial non-GLP dose-range studies using UOP produced material.
- Initiated discussions with a manufacturer and produced initial GLP lots.
- Conducted GLP safety and toxicology, pharmacology studies, absorption studies and other studies required to file an IND.
The Chemistry and Manufacturing Controls (CMC) are currently in development including analytical methods and product specifications. In addition, we have procured several lots of the product at different scales of production. The manufacturing process has proven to be scalable and we have entered into arrangements for the production of commercially representative lots for use in the human clinical studies.
