Research & Development
PharmaCyte Biotech Receives CE Mark for Licensed COVID-19 Molecular Tests
30 July 2020 - - The COVID-19 Molecular tests US-based biotechnology company PharmaCyte Biotech, Inc. (OTCQB: PMCB) licensed from Hai Kang Life Corp. Ltd. (Hai Kang) have received the CE mark, the company said.

The CE mark was given to the RT-PCR and ERT-PCR tests.

The Declaration of Conformity for the COVID-19 tests confirms that the tests meet the Essential Requirements of the European Community's In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD in the European Union member countries.

PharmaCyte Biotech, Inc. (PharmaCyte) 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."

The plan is to use this technology as a platform upon which therapies for several types of cancer and diabetes could be 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 should 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 should result in little to no treatment related side effects.

PharmaCyte's therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body.

PharmaCyte is also considering the use of genetically altered stem cells to treat diabetes. The cell encapsulation will be done using the Cell-in-a-Box technology.

Once the encapsulated cells are implanted in a diabetic patient, we anticipate they should function as a "bio-artificial pancreas" for purposes of insulin production.

Until the FDA allows PharmaCyte to commence the clinical trial described in its IND involving LPAC, PharmaCyte is not spending any further resources developing this programme.


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