On September 18, 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 its partner, Austrianova, has successfully performed an additional pre-production "engineering run" using the Cell-in-a-Box encapsulated cells that will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, SEP 18, 2018, View Source [SID1234529474]).
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On the advice of PharmaCyte’s Chief Scientific Officer and Austrianova, who will be performing the full production process of PharmaCyte’s clinical trial material, it was decided that the first production run would be deemed an engineering/pre-production run to be conducted before the production run to produce clinical trial material begins.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are happy to report that the encapsulation portion of the process during the pre-production run went flawlessly. Our decision has proven to be the correct course of action. We have much more information on how the cells from the Master Cell Bank (MCB) perform during and after encapsulation. The experience we have gained allowed Austrianova to make minor, but important, changes to the cell culture portion of the full production process. Completing the full production process and testing the final product now are the major items that remain to be accomplished before submitting our IND to the FDA."
The full production process consists of several steps with the most important being (i) the encapsulation process and (ii) the subsequent culturing of the encapsulated cells. PharmaCyte’s Cell-in-a-Box technology, with the live cells inside, must be placed in a "culture bath" long enough for the capsules to become filled with about 10,000 living cells that stop dividing upon contact with neighboring cells. If the capsules contained dividing cells, those cells would be killed (and rendered useless for cancer therapy) within the capsules when the ifosfamide prodrug was administered.
The decision to regard the run as an engineering run before the final production run occurs resulted, partly, due to learning that the cells from the MCB produced by Eurofins show slightly altered growth properties when compared to the cells that were previously tested and then used to prepare the MCB. This finding is not unusual when a new cell bank is established. However, since any alterations in the growth characteristics of the cells from the MCB that were used for the current encapsulation run might impinge on aspects of the overall production process, to have any anomalies well characterized and in line with regulatory guidelines, this additional engineering run was performed.
The knowledge gained from the two engineering runs should allow for the final production run to produce clinical trial material to begin. Austrianova completed the entire production process a few weeks ago and since then has successfully filled syringes with capsules that were produced during this pre-production run. This process was carried out to mimic what will be done in the final production run from encapsulation to preparing for direct shipment of PharmaCyte’s live-cell product to clinical trial study sites