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PharmaCyte Biotech Announces Additional Quality Control Assay and Confirms Stability of CypCap Cells
LAS VEGAS--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes
About this update from Pharmacyte Biotech, Inc.
[{"type":"text","content":" LAS VEGAS--(BUSINESS WIRE)--\nPharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced the results of a study to determine whether a previous established quantitative real-time PCR (qRT-PCR) could be used as a quality control test for its CypCaps™ product candidate. The qRT-PCR was used to gain data from testing of syringes from clinical batches of PharmaCyte’s cGMP production for its planned clinical trial in locally advanced, inoperable pancreatic cancer.\n\nPharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented on this new confirming assay, saying, “With the completion of this study, the Company has fulfilled one more important item from the long list of required U.S. Food and Drug Administration (FDA) tasks for our pancreatic cancer product candidate. We are particularly pleased that this independently performed qRT-PCR shows yet again the stability at the genetic level of the cytochrome P450 expressing cells which form the engine for our CypCaps clinical trial product. Additionally, we continue to make uninterrupted progress and remain steadfast in our efforts to resubmit an Investigational New Drug Application to the FDA and have our clinical hold lifted.”\n\nThe study, performed by a third-party laboratory, confirmed that the qRT-PCR can be successfully implemented for testing, and it also confirmed the identity and stability of the cytochrome P450 expression construct in the cells used for the production of CypCaps both before and after encapsulation in the cGMP batches. The qRT-PCR will thus be used as a quality control (QC) release assay on future cGMP-grade clinical batches of CypCaps. The results obtained from the newly reported study also serve as additional evidence that the integrated cytochrome P450 construct is highly stable in the clinical cell line used for CypCaps.\n\nPharmaCyte is at the tail end of its process of fulfilling the FDA’s requests to enable the clinical hold to be lifted, having now successfully completed almost two dozen studies with only a few remaining to be completed. The Company expects to commence its two-phase pig study shortly, which is the last major study from the FDA.\n\nTo learn more about Ph...