On April 30, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the successful results of long-term studies on the type of cells that will be encapsulated using its Cell-in-a-Box technology and then combined with low doses of the cancer prodrug ifosfamide for the treatment of patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, APR 30, 2018, View Source [SID1234525857]).
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These studies, which have taken over three years to complete, are needed to develop the comprehensive dossier of information concerning the genetically engineered human cells that are encapsulated for use in PharmaCyte’s therapy for LAPC. This work is required by the U.S. Food and Drug Administration ("FDA") to be included in PharmaCyte’s Investigational New Drug Application (IND) PharmaCyte is in the process of preparing for submission to the FDA.
The long-term studies were designed to demonstrate that the cells did not alter their properties after long periods in cell culture. The successful nature of these studies ensured that the properties of the product will not change over time and that product manufactured now will be the same as product manufactured in the future.
Kenneth L Waggoner, Chief Executive Officer of PharmaCyte, said, "We are delighted with the results of these long-term studies. They are crucial to demonstrating the long-term functionality and other characteristics of our genetically engineered cells, the ‘Active Pharmaceutical Ingredient (API),’ we plan to encapsulate as part of our therapy for LAPC. We have shown the API continues to function as designed over lengthy periods of time. We now have a large dossier of data to reference in our IND that documents each of the important characteristics of our API."
The characteristics of the cells that were tested included their genetic composition, their metabolic activity and the amount of the active enzyme (cytochrome P450 2B1) produced that converts the inactive prodrug, ifosfamide, to its active cancer-killing form. Importantly, the studies also showed that the cells were stable in the absence of the use of "selection agents," meaning that the cytochrome P450 gene that had been introduced into the cells was stably integrated in the genome of the cells.