23 May 2022 - - US-based biotechnology company PharmaCyte Biotech, Inc. (NASDAQ: PMCB), which is focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, has initiated the first in a series of studies to test the ability of its pancreatic cancer therapy to treat malignant ascites, the company said.

The initiation of this first study was made possible after PharmaCyte's successful production of a Master Cell Bank as well as the demonstration that the Master Cell Bank is adventitious agent free.

In PharmaCyte's initial study, it aims to establish a mouse model of malignant ascites to serve as a basis for further CypCaps plus ifosfamide efficacy studies.

This study involves inoculating the peritoneal space of genetically susceptible mice with radiolabelled mouse colon carcinoma cells.

Study parameters include survival, clinical signs, body weight, assessment of tumor spread using fluorescence imaging and indexing of total tumor volume.

The planned series of studies will build on previous data obtained by Prof. Matthias Löhr of the Karolinska Institute in Stockholm, Sweden, and his colleagues that showed PharmaCyte's treatment for pancreatic cancer can slow the production and accumulation of malignant ascites.

Heidelberg Pharma Research, a leading German biotechnology company focused on cancer therapies, will conduct the study.

Ascitic fluid is normally produced in the peritoneum, a sheet of tissue that covers the organs in the abdomen; however, the presence of cancer can cause the peritoneum to produce too much ascitic fluid when cancer cells irritate the peritoneum, which causes the abdomen to swell as fluid accumulates. This is known as malignant ascites.

It is more likely to develop in patients who have ovarian, uterine, cervical, colorectal, stomach, pancreatic, breast and liver cancers. In most patients, development of malignant ascites is a sign of advanced disease and poor prognosis.

Malignant ascites can result in impairment to the quality of life of a cancer patient. In addition to abdominal distention, pain and difficulty breathing, it may also cause nausea, vomiting, early satiety, lower extremity edema, weight gain and reduced mobility.

These symptoms can interfere with a patient's ability to eat, to walk and to perform daily activities. They also reduce a patient's ability to withstand anti-cancer therapies, potentially reducing survival.

As a supportive or palliative measure, malignant ascites can be drained by paracentesis, percutaneously implanted catheters, peritoneal ports or peritoneovenous shunts.

These treatments are invasive, can be painful and are expensive. PharmaCyte expects its treatment to offer cancer patients a therapy that slows down or eliminates the production and accumulation of malignant ascites fluid.

There is currently no such treatment on the market.

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 is being 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 we believe 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 and release insulin in response to the levels of blood sugar in the human body.

The encapsulation of the cell line will be done using the Cell-in-a-Box technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a "bio-artificial pancreas" for purposes of insulin production.