On October 1, 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 that it has successfully determined the modified site and chromosome location of the cytochrome P450-2B1 gene in the DNA of the genetically altered human cells known as 22P1G that will be encapsulated and used together with the cancer prodrug ifosfamide in PharmaCyte’s upcoming clinical trial (Press release, PharmaCyte Biotech, OCT 1, 2018, View Source [SID1234529683]). The cytochrome P450-2B1 gene is responsible for producing the enzyme that activates the ifosfamide into its cancer-killing form. The "integration site" information from this study was another requirement requested by the FDA. The site of integration was to be defined and included in PharmaCyte’s Investigational New Drug Application (IND) before the start of the clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).
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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "This study answers one of the key questions that was raised in our pre-IND meeting with the FDA. It represents the culmination of a long, complicated and expensive series of experiments as well as interpretation of a plethora of data that was generated over the last 12 months and is congruent with earlier data that we generated. Without these findings, we would be unable to submit our IND to the FDA, so this completed study moves us a significant step closer to submitting our IND to the FDA."
The study was an exceedingly complicated one that involved the latest cutting-edge techniques such as Next Generation Sequencing (NGS) as well as more classical techniques of polymerase chain reaction (PCR) analysis and DNA sequencing. The comprehensive and voluminous set of data that was generated from these tests was subjected to a robust and multi-faceted analysis. In addition to providing a better characterization of the cells at the DNA level, this analysis has revealed that the cytochrome P450-2B1 expression construct is located on human chromosome 9 in PharmaCyte’s 22P1G cell line. Additional analyses have revealed that the location of the construct is in a benign region of the human genome that should be "safe." This supports the previous conclusion that the 22P1G cells have a good safety profile.
The data obtained from the in-depth analyses also confirm data that has been previously announced by PharmaCyte that concerned enzymatic assays and Southern blotting analyses (a method used in molecular biology for detection of specific DNA sequence in DNA samples) of the 22P1G cells.