On July 19, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has achieved positive interim results in its study to establish a malignant ascites mouse model which will form the basis for further testing of the effectiveness of its CypsCapsTM plus ifosfamide pancreatic cancer therapy for the treatment of malignant ascites (Press release, PharmaCyte Biotech, JUL 19, 2022, View Source [SID1234616759]).
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The study is being conducted by Heidelberg Pharma, a leading German biotechnology company focused on cancer therapies, using colon carcinoma cells from a Master Cell Bank established by Austrianova implanted in genetically susceptible mice. Primary objectives include establishing parameters with respect to (i) optimum tumor cell inoculation dose; (ii) timing curve with respect to tumor growth; and (iii) the most accurate method to assess tumor burden. The last point is particularly important because it provides a gauge to measure the effectiveness of therapeutic interventions.
Initial data in the study indicate that a measure of overall tumor volume is likely a more accurate way of tracking tumor burden when compared to measuring labeled tumor cell fluorescence. Tumor volume in the study is being reported using an adaptation of the Sugarbaker-index. The Sugarbaker-index is a widely used and accepted quantitative prognostic indicator for patients with malignant ascites.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are highly encouraged that Heidelberg Pharma’s work with this study to establish a malignant ascites mouse model is proceeding exactly as we had hoped and that it has yielded valuable information as we work diligently to advance our therapy for malignant ascites. We are confident that all our objectives in this study will be achieved. We will continue to keep our shareholders informed as work progresses at Heidelberg Pharma."
Malignant ascites is caused by an accumulation of fluid in the peritoneum causing the abdomen to swell as a result of cancer. It is often associated with ovarian, uterine, cervical, colorectal, stomach, pancreatic, breast and liver cancers. Malignant ascites can result in significant impairment to the quality of life of a cancer patient and reduce survival. Currently, available treatments are mainly supportive and palliative. In most patients, development of malignant ascites is a sign of advanced disease and poor prognosis.
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.