PharmaCyte Biotech Proceeding with GMP Production of Pancreatic Cancer Product After Successful Changes to Manufacturing Process

On May 20, 2019 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 made further important progress in optimizing the complete manufacturing process, including significant improvement of the growth characteristics of the cells from PharmaCyte’s Master Cell Bank (MCB) after encapsulation (Press release, PharmaCyte Biotech, MAY 20, 2019, View Source [SID1234536480]). These encapsulated cells 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).

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PharmaCyte can now provide additional information as an update to its recent press release on the production of its clinical trial product called, "CypCaps." PharmaCyte, together with its team of experts, has successfully implemented additional changes to the manufacturing process that have resulted in a remarkably improved and more reproducible encapsulated live cell product.

Use the link below to view a picture that captures the growth process post encapsulation from day 8 to day 22 of the cells from the MCB. In the linked picture, you will see the cells from the MCB growing in the capsules over the course of 22 days. On day 22 the cells in the capsules have stopped growing because of contact inhibition and have been placed into syringes and frozen. They have also been thawed and tested for viability and the level of enzymatic activity necessary to convert ifosfamide from its inactive form to its cancer-killing form. Both tests met the required specifications: View Source

As previously reported, the cells from PharmaCyte’s MCB that were produced by Eurofins Lancaster Laboratories showed slightly different growth properties when compared to the cells that were previously tested by Austrianova from PharmaCyte’s Research Cell Bank, a finding that is not unusual when a new cell bank is established. Although minor in nature, these different growth characteristics of the MCB cells initially affected many of the steps required for the overall production process of the CypCaps, necessitating counter measures to re-align and restructure the production process.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "With these changes in place, GMP production of the CypCaps for PharmaCyte can now proceed at Austrianova’s manufacturing facility in Bangkok, Thailand.

"This is great news for everyone who has worked so diligently through what has been a complicated and meticulous process to get the production of our clinical trial product exactly right before we approach the FDA with an Investigational New Drug application. It’s also great news for our many shareholders who have waited patiently as we navigated these unchartered waters with encapsulating the live cells from our MCB."