Therapy Areas: Diabetes
PharmaCyte Biotech Releases Study Results
5 July 2022 - - US-based biotechnology company PharmaCyte Biotech, Inc. (NASDAQ: PMCB) has posted 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 company said.

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.

The 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 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.

PharmaCyte 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.

PharmaCyte Biotech is a biotechnology company developing cellular therapies for cancer, diabetes and malignant ascites based upon a proprietary cellulose-based live-cell encapsulation technology known as "Cell-in-a-Box."

This technology is being used as a platform upon which therapies for several types of cancer, diabetes and malignant ascites are being developed.


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