On June 14, 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 completed the comprehensive characterization of its proprietary cell clone known as 22P1G (Press release, PharmaCyte Biotech, JUN 14, 2018, View Source [SID1234527315]).
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The 22P1G cells constitute the cells in the Master Cell Bank (MCB) that were prepared and tested by PharmaCyte’s contractor, Eurofins Lancaster Laboratories. The cells from the MCB will serve as the active pharmaceutical ingredient (API) in the company’s Cell-in-a Box capsules that will be used (together with low doses of the cancer prodrug ifosfamide) for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) in its planned clinical trial.
The comprehensive characterization studies include long-term stability of the cells, and stability of the potency of the cells as a therapeutic. All studies performed are required by the U.S. Food and Drug Administration (FDA).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, elaborated on the significance of the studies saying, "PharmaCyte is complying with all of the FDA guidelines and recommendations for all cell tests and other recent studies with the 22P1G cells. Successful completion of these studies was a pre-requisite for the approval by the FDA for us to conduct a clinical trial in patients with LAPC. Our treatment is primarily dependent upon genetically engineered live-human cells that produce a particularly potent cytochrome P450 enzyme that can activate the chemotherapy prodrug ifosfamide (clone 22P1G cells).
"With each individual batch, these cells must be stable for the long term, and the properties of the 22P1G cells must remain consistent from batch to batch. The newly completed studies provide evidence that both requirements have been met. Our pancreatic cancer treatment utilizes 22P1G cells that have been encapsulated using the Cell-in-a-Box technology. For treatment of LAPC patients, the capsules containing the cells are implanted near the pancreatic tumor so that a high local concentration of the cancer-killing ifosfamide metabolite is produced near the tumor."