On July 13, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD) (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, reported that after 3 years of storage in a vapor phase of liquid nitrogen, the original cytochrome P450 expressing cells from PharmaCyte’s Master Cell Bank (MCB) manufactured by Eurofins Lancaster Laboratories continue to retain their viability and excellent enzymatic activity, both of which are critical stability parameters (Press release, PharmaCyte Biotech, JUL 13, 2021, View Source [SID1234584825]).
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This study is in addition to, and distinct from, the previously positive stability study test results of the CypCaps product after storage at -80C over various timepoints.
The enzymatic activity is the property that causes the activation of low dose ifosfamide in patients and subsequently the killing of their cancerous tumors. Thus, having good enzymatic activity is a direct measure of the effectiveness of the cells. It is important to show stability of the MCB cells since these cells will be used as a resource for continued production of future batches of PharmaCyte’s clinical trial product referred to as CypCaps. For this reason, the U.S. Food and Drug Administration requested that the stability of the MCB cells be analyzed.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are pleased to have generated data on the viability and enzymatic activity of cells from our Master Cell Bank after 3 year’s storage. The study will proceed over the next three years to obtain the maximum stability of the cells from the MCB after continuous storage in liquid nitrogen, ensuring that we have a resource for future production of our CypCaps as this novel therapy makes its way into the clinic."