It was titled "Encapsulated Cells Producing Cytochrome P450 and Methods of Use Thereof."
This PCT application allows PharmaCyte to file patent applications and seek protection in most major market countries throughout the world.
These patent applications, if granted, will provide protection for PharmaCyte's technology for 20 years without a gap in patent protection, until March 2038.
The PCT application also specifically includes methods of treating other cancerous tumors, such as those of the liver, breast and colon, using the live-cell encapsulation of genetically modified human cells that overexpress a form of the cytochrome P450 enzyme system normally found in the liver.
These cells are encapsulated using the proprietary Cell-in-a-Boxtechnology. Together with low doses of a drug of the oxazaphosphorine class, ifosfamide, the encapsulated cells comprise PharmaCyte's therapy for pancreatic cancer.
The patent application also includes using PharmaCyte's platform technology with cyclophosphamide, another chemotherapy drug of the oxazaphosphorine class that is activated by the cytochrome P450 enzyme system.
In the case of pancreatic cancer, it is hoped that the Cell-in-a-Box plus low dose ifosfamide combination will be beneficial to patients whose pancreatic tumors become resistant to standard chemotherapies such as the combination of the anticancer drugs gemcitabine and Abraxane or FOLFIRINOX.
The use of Cell-in-a-Box encapsulation with other drugs against other forms of cancer remains to be investigated.
The PCT patent application originated from a provisional patent application by the same title that was filed with the US Patent and Trademark Office (USPTO) on 21 March 2017 and a patent application by the same title that was filed with the USPTO on March 21, 2018.
PharmaCyte Biotech is a clinical stage 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.
The company'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 and developed 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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