PMCB - PharmaCyte initiates testing of cell therapy in response to FDA recommendations

PharmaCyte Biotech ([[PMCB]] +1.9%) has commenced additional physical parameter testing of its CypCaps encapsulated cells for pancreatic cancer, in line with the recommendations provided by the FDA.The FDA has asked that two additional methods be developed to determine the strength of PharmaCyte’s CypCaps to be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer.One method involves pressing down on the capsule and measuring either the pressure required for it to burst, or for it to deform. While the second method involves letting water flow into the CypCaps, effectively “blowing them up.”Thus, these FDA mandated studies can be seen as additional release tests to ensure the reproducibility of the CypCaps.In the meantime, PharmaCyte continues to work with its partners to address the other issues raised by the FDA that led to the clinical hold.

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PharmaCyte initiates testing of cell therapy in response to FDA recommendations