Year 1

During this reporting period, we have developed an API manufacturing process and successfully manufactured 8.8 Kg of the PCC to cGMP at a purity of 99.89%, which will be sufficient for the following IND-enabling studies as well as phase 1 clinical trials. We have also developed formulations for the PCC for intra-articular and intravenous administrations, which will be used to study the toxicology and pharmacokinetics of the PCC in rats and dogs. Furthermore, bioanalytical methods for the identification and quantification of the API in dosing formulations and biological samples (e.g., plasma) have been developed and validated, which will be applied to support the following IND-enabling studies. We have also established the most tolerated doses (MTD) of the PCC in both rats and dogs, which will guide the following GLP toxicology studies. Other proposed ADME and safety studies are currently ongoing that are expected to conclude by the end of the next reporting period.