LAS VEGAS– PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that the empty capsule material that makes up PharmaCyte’s CypCaps® pancreatic cancer product candidate is not toxic for the encapsulated cells inside the CypCaps.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We have completed another study that proves exactly what we expected to find in the data. Like previous biocompatibility studies on our CypCaps product candidate to treat locally advanced, inoperable pancreatic cancer (LAPC), this study demonstrates that the capsule material is not in any way toxic to our encapsulated live cells. This study also confirms previously obtained data that the capsule material is bio-inert.”
The study was performed to assess the cytotoxic (cell toxicity) potential of extracts of cellulose sulphate capsules using a standard line of mouse fibroblast cells known to be sensitive to toxic influences. The study was performed in compliance with the OECD Principles of Good Laboratory Practice [C(97)186/Final and ENV/MC/CHEM(98)17], International Standard (ISO) 10993-5, Third Edition 2009-06-01, “Biological Evaluation of Medical Devices – Part 5: Tests for In vitro cytotoxicity,” and International Standard (ISO) 10993-12, Fifth Edition 2021-01, “Biological Evaluation of Medical Devices – Part 12: Sample preparation and reference materials.”
Extracts of the capsule material were prepared by a third-party Contract Research Organization (CRO) laboratory using physiological saline or dimethyl sulphoxide (DMSO) as solvents. Different concentrations of each of the extracts were added to mouse fibroblast cells. The cells were examined 24 hours later under the microscope by the CRO for any abnormal cell morphology and the possible presence of cell lysis. The capsule material was found to be “non-cytotoxic” to mouse fibroblast cells at all of the concentrations examined.
