PharmaCyte Ships Clinical Trial Cells to Austrianova for Encapsulation
PharmaCyte Biotech, Inc. announced that vials of cells from PharmaCyte’s Master Cell Bank (MCB) have been shipped by Eurofins Lancaster Laboratories (Eurofins) to Austrianova’s encapsulation facility in Thailand. The cells from the MCB will be encapsulated and then tested by Austrianova after encapsulation. This post-encapsulation testing will generate the remaining data required by the U.S. Food and Drug Administration (FDA) to be included in PharmaCyte’s Investigational New Drug Application (IND). For the cells to be shipped and accepted into Austrianova’s GMP encapsulation facility, they had to pass mandatory sterility and mycoplasma testing by Eurofins.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are extremely pleased to make this announcement. It represents a major step forward in preparations for our planned clinical trial to treat locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC). After encapsulation, further testing will be done by Austrianova. The data from these tests, along with data from the tests done by Eurofins and its subcontractors, will be included as an integral part of our IND.”
Austrianova’s Chief Executive Officer, Brian Salmons, said, “We are excited to receive vials of cells from the MCB produced by Eurofins. The next step will be the encapsulation of these cells followed by another round of sterility testing and numerous quality control tests. After this is completed, the encapsulated cells in a syringe will be shipped to PharmaCyte for use in its planned clinical trial.”
Before the cells were shipped, they had undergone and passed numerous tests completed by Eurofins and its subcontractors. Several tests are still ongoing. The large number of tests that PharmaCyte must complete on the cells are necessary to meet the FDA’s requirements. The lengthy amount of time it has taken to complete these tests is because PharmaCyte is using genetically modified live human cells as part of its combination product that utilizes the Cell-in-a-Box technology plus low dose ifosfamide as a novel therapy to treat LAPC.