PharmaCyte Biotech aiming to develop targeted cellular therapies for Cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announced that its 6-month study on storage of the frozen encapsulated cells necessary for the determination of an “initial shelf life” has been successfully completed by Austrianova.
The work encompassed removal of samples of encapsulated cells from -80o Celsius (C) storage at various intervals up to six months, thawing the encapsulated cells and testing them for various functional parameters as well as for sterility. Regulatory agencies, including the U.S. Food and Drug Administration (FDA), require that studies be conducted to determine an initial shelf life for a medicinal product before an advanced phase clinical trial can begin. This shelf life can then be extended with further testing as the product is being used in the clinical trial. Austrianova Singapore already has data demonstrating storage life of frozen encapsulated cells for over six years; however, these studies were done with a slightly different cell line than the cell line that will be used for PharmaCyte’s planned clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are pleased with this significant result which will enable us to apply to the FDA for an initial shelf life of six months. This study, one of many being performed for us by Austrianova, is an essential part of the Investigational New Drug Application (IND) that we will be submitting to the FDA.”