PharmaCyte Biotech Inc (PMCB)

[rayla1961]

it is essential that the ifosfamide can easily and quickly enter the capsules so that it can be efficiently converted into the ifosfamide tumor-killing metabolite. It is equally important that this metabolite can then exit the capsules and destroy the tumor. The completed studies clearly demonstrate that this is the case and underscore the stability of the capsules over the freezing, transport and storage cycle.”

As part of PharmaCyte’s Investigational New Drug Application (IND) for its clinical trial in patients with LAPC, the FDA required PharmaCyte to provide data showing that the size of the pores in the outer shell of the Cell-in-a-Box® capsules is appropriate to allow ifosfamide to enter the interior of the capsules where the ifosfamide-activating cells are located. Additionally, PharmaCyte is required to provide data showing that the pores are also of appropriate size to allow the activated form of ifosfamide to leave the capsules.