commenced additional studies to determine the exact sequence of the DNA encoding of the enzyme in the cells of its CypCaps® product for pancreatic cancer and the stability of the sequences, in line with the requests provided by the U.S. Food and Drug Administration (FDA).
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PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has commenced additional studies to determine the exact sequence of the DNA encoding of the enzyme in the cells of its CypCaps® product for pancreatic cancer and the stability of the sequences, in line with the requests provided by the U.S. Food and Drug Administration (FDA).
The cell clone used to produce the CypCaps® product has been augmented to produce the cytochrome P450 enzyme. This enzyme converts ifosfamide from its inactive form to its cancer-killing form and is the basis for how CypCaps® works. PharmaCyte has already shown that the enzyme is produced, that the expression of the enzyme is stable over time and that the enzyme is functional. The FDA has now asked PharmaCyte to provide the exact DNA sequence and configuration of the genetic augmentation responsible for the production of cytochrome P450 in the cells. This requires additional studies that necessitates a multi-prong approach, including the employment of a new, state of the art, technique.
The information provided by these analyses will also strengthen and extend the already existing data that has been presented to the FDA by PharmaCyte on (i) the site of integration of the DNA encoding of the cytochrome P450 enzyme; and (ii) the data on the stability of the cells, even before they are encapsulated using the Cell-in-a-Box® to produce the CypCaps® product. Thus, these new studies will add to the data that PharmaCyte already has on the long-term stability and shelf life of the final CypCaps® product.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "Our team is pleased that we’ve commenced these additional studies and that we’re on a path to address more of the FDA’s comments regarding our treatment for locally advanced, inoperable pancreatic cancer (LAPC). As well as addressing the FDA’s comments, the information that will be created by these studies will bolster and augment our existing data on the stability of the cells used in the CypCaps® product. While the data generated will not change the fact that the CypCaps® product is functional, biologically active, and effective, it will generate further data on the exact configuration of the DNA that gives rise to the therapeutic effects of CypCaps®."
