On December 8, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the results of an additional, more detailed, analysis of the integration site of the cytochrome P450 2B1 gene from the augmented HEK293 cell clone that PharmaCyte uses in its CypCap product (Press release, PharmaCyte Biotech, DEC 8, 2021, View Source [SID1234596612]). This assay is one of the assays required by the U.S. Food and Drug Administration (FDA) in order to have the FDA’s clinical hold lifted on PharmaCyte’s Investigational New Drug Application (IND) for the treatment of locally advanced, inoperable pancreatic cancer (LAPC).
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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are elated to have completed this sequencing assay given its importance to the FDA, and how incredibly difficult it was to arrive at this successful conclusion. We can report that the DNA sequence analysis of the cytochrome P450 2B1 augmented cells is now complete, and it is a great challenge that is now behind us. This kind of analysis is technically demanding, and we spent a great deal of time getting this right. In addition to extending our characterization of the augmented cells, the data also verifies our previous studies on the cells that are the active component of our novel LAPC therapy."
In previous studies, PharmaCyte showed that the cytochrome P450 2B1 gene in the augmented HEK293 cell clone was located on human chromosome 9 and the flanking sequence had already been determined. The FDA requested that the exact sequence of the cytochrome P450 2B1 gene inserted at that location should also be determined. This is technologically challenging because the introduced DNA is large and concatenated, causing the Company to turn to nanopore sequencing technology for this analysis. Nanopore sequencing is a cutting edge, unique and scalable technology that enables direct, real-time analysis of long DNA fragments. The technology was successfully used to determine the sequence of the introduced DNA, and the analysis of the sequence data shows that it is both intact and complete.
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source