The product is now ready for "release testing." The data from the "release testing" of both manufacturing runs will be included in an Investigational New Drug application and submitted to the US Food and Drug Administration to support PharmaCyte's planned clinical trial in patients with locally advanced, inoperable pancreatic cancer.
The capsules, which are fully filled with genetically modified live cells, were immediately put into PharmaCyte's clinical trial syringes and then frozen.
Austrianova has shipped a representative sample of the frozen syringes to third-party laboratories in Europe to undergo "release testing" related to the "safety" of the product. Austrianova will conduct "release testing" in-house related to the "functionality" of the encapsulated cells.
PharmaCyte Biotech is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as "Cell-in-a-Box."
This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
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