LAS VEGAS– PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has initiated the first in a series of studies to test the ability of its pancreatic cancer therapy to treat malignant ascites. 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.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “The expansion of our oncology program is continuing with the pursuit of a treatment for malignant ascites. This patient population is dealing with advanced cancer, and malignant ascites only compounds the problems these patients must endure at a very difficult time. The establishment of a reliable malignant ascites animal model is a critical step on the path to create a first-ever treatment for malignant ascites and represents our desire to address unmet medical needs and the patient’s quality of life.”
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.
