Pharmacyte Biotech, Inc. Releases More Positive Results from U.S. Food and Drug Administration-Required Biocompatibility Tests
September 21, 2021 at 09:00 am EDT
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PharmaCyte Biotech, Inc. announced 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.” 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.
PharmaCyte Biotech, Inc. is a biotechnology company. It is focused on developing cellular therapies for cancer, diabetes, and malignant ascites based upon a cellulose-based live cell encapsulation technology known as Cell-in-a-Box. Its product candidate is referred to as CypCaps. The Cell-in-a-Box encapsulation technology potentially enables genetically engineered live human cells to be used to produce various biologically active molecules. It is advancing clinical research and development of new cellular-based therapies in oncology and diabetes. It is also focused on developing therapies for pancreatic and other solid cancerous tumors by using genetically engineered live human cells. Its product candidate for the treatment of diabetes consists of encapsulated genetically modified insulin-producing cells. It is also focused on the benefits of the Cell-in-a-Box technology to develop therapies for cancer that involve prodrugs based upon certain constituents of the Cannabis plant.
PHARMACYTE BIOTECH, INC. 
