PharmaCyte Biotech, Inc. 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. 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.