PharmaCyte Biotech Begins DNA Sequence and Stability Studies in Response to FDA Requests for Its Clinical Trial Product
January 26, 2021 at 02:00 pm
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PharmaCyte Biotech, Inc. announced 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 Biotech, Inc. is a biotechnology company. It is focused on developing cellular therapies for cancer, diabetes, and malignant ascites based upon a cellulose-based live cell encapsulation technology known as Cell-in-a-Box. Its product candidate is referred to as CypCaps. The Cell-in-a-Box encapsulation technology potentially enables genetically engineered live human cells to be used to produce various biologically active molecules. It is advancing clinical research and development of new cellular-based therapies in oncology and diabetes. It is also focused on developing therapies for pancreatic and other solid cancerous tumors by using genetically engineered live human cells. Its product candidate for the treatment of diabetes consists of encapsulated genetically modified insulin-producing cells. It is also focused on the benefits of the Cell-in-a-Box technology to develop therapies for cancer that involve prodrugs based upon certain constituents of the Cannabis plant.