21 May 2019 - - US-based clinical stage biotechnology company PharmaCyte Biotech, Inc. (OTCQB: PMCB) has made further progress in optimising the complete manufacturing process, including significant improvement of the growth characteristics of the cells from PharmaCyte's Master Cell Bank after encapsulation, the company said.

These encapsulated cells will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer.

PharmaCyte can now provide additional information as an update to its recent press release on the production of its clinical trial product called, "CypCaps."

PharmaCyte, together with its team of experts, has successfully implemented additional changes to the manufacturing process that have resulted in a remarkably improved and more reproducible encapsulated live cell product.

Use the link below to view a picture that captures the growth process post encapsulation from day 8 to day 22 of the cells from the MCB. In the linked picture, you will see the cells from the MCB growing in the capsules over the course of 22 days.

On day 22 the cells in the capsules have stopped growing because of contact inhibition and have been placed into syringes and frozen. They have also been thawed and tested for viability and the level of enzymatic activity necessary to convert ifosfamide from its inactive form to its cancer-killing form.

As previously reported, the cells from PharmaCyte's MCB that were produced by Eurofins Lancaster Laboratories showed slightly different growth properties when compared to the cells that were previously tested by Austrianova from PharmaCyte's Research Cell Bank, a finding that is not unusual when a new cell bank is established.

Although minor in nature, these different growth characteristics of the MCB cells initially affected many of the steps required for the overall production process of the CypCaps, necessitating counter measures to re-align and restructure the production process.

PharmaCyte's chief executive officer, Kenneth L. Waggoner, said, "With these changes in place, GMP production of the CypCaps for PharmaCyte can now proceed at Austrianova's manufacturing facility in Bangkok, Thailand.

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.

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 little to 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.

PharmaCyte is exploring the use of genetically modified liver cells, stem cells and/or 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 will function as a "bio-artificial pancreas" for purposes of insulin production.