The company anticipates that one kilogram of Adva-27a will be sufficient to complete the upcoming IND-Enabling animal toxicity studies and Phase I clinical trials.
By completing the animal toxicity studies, the company expects to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) and wait for authorization to continue with the Phase I clinical trial.
Sunshine Biopharma president and CEO Steve Slilaty said, "The filing of our process patent to protect Adva-27a manufacturing in January this year allowed us to quickly move forward and securely share information with CMO’s to supply us with kilogram quantities of Adva-27a to complete the data for the IND application and conduct Phase I clinical trials."