The cells are now growing and dividing inside the Cell-in-a-Box capsules.
Since its pre-production "engineering runs" in late 2018, Austrianova has further enhanced the manufacturing process and equipment.
Once the testing of the syringes is successfully completed, the data and reports generated from this process will allow the completion of the Investigational New Drug application that must be submitted to the US Food and Drug Administration to apply for approval to begin a clinical trial in LAPC.
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.
PharmaCyte's therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or "cancer-killing" form.
For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient's tumor as close as possible to the site of the tumor.
Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose.
The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a "bio-artificial liver" and activate the chemotherapy drug at the site of the cancer.
This "targeted chemotherapy" has proven effective and safe to use in past clinical trials and results in no treatment related side effects.
PharmaCyte's therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The cell lines being studied are human liver cells, stem cells and beta islet cells.
The encapsulation will be done using the Cell-in-a-Box technology. Once the encapsulated cells are implanted in a diabetic patient, they are designed to function as a "bio-artificial pancreas" for purposes of insulin production.
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