On September 27, 2021 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, reported further results from a third test of biocompatibility of its CypCaps product candidate for pancreatic cancer (Press release, PharmaCyte Biotech, SEP 27, 2021, View Source [SID1234590330]). The tests results showed that the empty capsule material is not "mutagenic." A mutagen is a physical or chemical agent that permanently changes genetic material, usually DNA, in an organism and thus increases the frequency of mutations above the natural background level.
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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "As we continue to receive data from a myriad of tests that are currently in progress, we are generating exactly the data we expected to generate when we began addressing the U.S. Food and Drug Administration’s desire to see more data. These latest test results continue to support the safety of PharmaCyte’s product candidate, CypCaps. In line with data generated previously, we are confident that the encapsulation material used for CypCaps is biocompatible, safe and not toxic. Each of the tests that we’re conducting should continue to demonstrate this."
The study, which was performed by a third-party Contract Research Organization (CRO) in compliance with OECD Principles of Good Laboratory Practice [C(97)186/Final and ENV/MC/CHEM (98)17] and in accordance with four regulatory guidelines (OECD and ISO) was designed to determine if the device component of CypCaps (the empty capsule material) can cause mutations by altering DNA. The specific objective of the study was to evaluate whether two differently prepared extracts of empty capsule material can induce reverse mutations in specific genes in four indicator strains of bacteria Salmonella typhimurium and one indicator strain of Escherichia coli. The third-party CRO concluded from the data obtained that the empty capsule material is "non-mutagenic."
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source