Sunshine Biopharma Inc., a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, is pleased to report that following negotiations with several Contract Manufacturing Organizations ("CMOs") for the GMP (Good Manufacturing Practice) manufacturing of one kilogram of Adva-27a breast cancer drug candidate, the Company has narrowed the field of contenders to three CMOs. While there are timeframe variations among these three manufacturers, largely related to the availability of their large scale chemical reactors at the time we place our order, overall it will take approximately 10 to 14 weeks for a one kilogram GMP synthesis of Adva-27a to be delivered to us.
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. These are required to be performed using the same GMP manufactured material. Following completion of the animal toxicity studies, the Company expects to file an Investigational New Drug (IND) application with the FDA (U.S. Food and Drug Administration) and wait for authorization to proceed with the planned Phase I clinical trial scheduled to be hosted at McGill University's Jewish General Hospital in Montreal, Canada. The Company intends to make any leftover material available for "compassionate-use" programs that allow seriously-ill cancer patients gain access to the drug candidate.
"We are excited to be at the stage of conducting GMP manufacturing of our drug," said Dr. Steve N. Slilaty, President and Chief Executive Officer of Sunshine Biopharma. "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.