On September 27, 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 a study to determine the best assay method for the accurate determination of the number of viable encapsulated cells at any given time inside PharmaCyte’s Cell-in-a Box capsules, which will be used for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, SEP 27, 2018, View Source [SID1234529632]).
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The decision on which viability assay to use is an important component required for the filing of PharmaCyte’s Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA), since the viable cell assay is needed to show how many living cells are in the capsules at any given moment. This is a parameter that influences the biological activity of PharmaCyte’s Cell-in-a-Box encapsulated cell product.
This particular study compared three different methods for determining the number of viable cells in the capsules as well as the growth rate of the cells within the capsules. Although the rate of growth has already been fixed as part of the production process (and is not affected by this study), the new data revealed that only one of the tested methods can accurately estimate the number of cells within a capsule, particularly when the capsules are populated at high cell densities as they will be for use in PharmaCyte’s clinical trial in patients with LAPC. Therefore, this study provides the justification for the use of the most accurate and sensitive assay chosen by this study, which will also be used for quality control of the product release for the upcoming planned clinical trial for LAPC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained the significance of the study saying, "The cells that are encapsulated using the Cell-in-a-Box technology are the engine for the final product in that they activate the chemotherapeutic agent ifosfamide at the site of the tumor in the pancreatic cancer patient. This study is important since it shows we now have at our disposal the best method to determine the actual number of living cells in the capsules.
"The data from this study is another key piece of information required for PharmaCyte to comply with FDA guidelines and recommendations for our planned, upcoming clinical trial in patients with LAPC. This viability information must be reliable; therefore, it is also valuable for ensuring good quality control of our final product. In other words, using the chosen viability measuring method will help us ensure that the Cell-in-a-Box encapsulated product is reproducible from batch to batch. This is an essential requirement for any medicinal product."