On September 21, 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 the results of a second U.S. Food and Drug Administration (FDA)-required test of biocompatibility of its CypCaps product for pancreatic cancer, which showed that the empty capsule material is "non-hemolytic (Press release, PharmaCyte Biotech, SEP 21, 2021, View Source [SID1234590083])."
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The Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, said of the positive results, "We’re pleased to report that we have received positive results from the second of the biocompatibility tests performed under Good Laboratory Practices and required by the FDA in connection with PharmaCyte’s clinical hold. The data shows that, as expected, the capsule material does not cause blood cells to lyse either after direct or indirect contact with blood. Moreover, it confirms prior data that was observed previously in animal models and previous clinical trials."
The study, which was performed by a third-party Contract Research Organization in accordance with ISO 10993-4:2017 and ISO 10993-12:2021(E), was designed to determine if the device component of CypCaps (the empty capsule material) can cause the in vitro hemolysis (destruction) of red blood cells. Two different methods were used for the evaluation: (i) a direct contact method where the capsule material was mixed with rabbit blood; and (ii) an indirect method where the capsule material was extracted with saline and mixed with rabbit blood. The hemolytic index of both the empty capsules and the extraction material was such that the Contract Research Organization concluded that the test item in both the direct contact method and indirect contact method is considered as "non-hemolytic."
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