A master drug file contains all of the information that regulatory agencies require as part of the drug development and approval process. Such information includes preclinical data, GMP manufacturing process, large animal studies and human trials.
"Engaging a CRO is the next step in our Adva-27a drug development program," said Dr. Steve N. Slilaty, CEO of Sunshine Biopharma.
"We are delighted to have arrived at this advanced stage in the development of our Adva-27a. The CRO will compile the testing results conducted to date, follow and document the GMP manufacturing process, manage the large animal studies and file with the appropriate regulatory agencies for go-ahead with Phase I human trials."
Adva-27a is Sunshine Biopharma’s lead anticancer compound, a small molecule that has recently been shown to be effective at killing Multidrug Resistant Breast Cancer cells, Small-Cell Lung Cancer cells, Uterine Sarcoma cells and Pancreatic Cancer cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012).
Adva-27a is currently in the IND-Enabling stage of development. The original U.S. patent covering Adva-27a was issued on August 7, 2012 under U.S. patent number 8,236,935.
The Company is planning a Phase I clinical trial of Adva-27a for Pancreatic Cancer in parallel to the Phase I clinical trial of Adva-27a for multidrug resistant Breast Cancer to be conducted at McGill University’s Jewish General Hospital in Montreal (Canada).