Ascites is the buildup of fluid in the abdominal cavity that occurs in patients with certain diseases. Ascites caused by cancer is called malignant ascites and accounts for 10% of people with ascites. Malignant ascites appears most often in people with breast, colon, liver, gastrointestinal tract (stomach and intestines), and ovarian, pancreatic, and uterine cancers. Research being performed by TD2 and being funded by Silver Spring Maryland-based PharmaCyte Biotech, Inc., a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, is designed to determine whether PharmaCyte Biotech’s pancreatic cancer treatment can slow the accumulation of malignant ascites fluid. This pancreatic cancer treatment is a combination of low doses of the cancer prodrug ifosfamide coupled with Cell-in-a-Box® capsules containing live cells capable of converting ifosfamide into its cancer-killing form.
In an initial study, mice given an aggressive human ovarian cancer (ES-2), which produces significant amounts of malignant ascites fluid, were divided into 4 groups. There were 10 mice in each group. The mice in Group 1 served as a control group. Group 2 was made up of mice treated with PharmaCyte Biotech’s pancreatic cancer treatment. Group 3 was treated with cisplatin, a chemotherapy drug often used to treat ovarian cancer. Group 4 was treated with a combination of PharmaCyte Biotech’s pancreatic cancer treatment and cisplatin.
A follow-up study will use the same ES-2 ovarian cancer model. In this study, the mice will be divided into 12 different treatment groups, with 10 mice in each group. The follow-up study is designed to better define the parameters that will be needed to design a future Phase 1 clinical trial in humans that suffer from malignant ascites fluid accumulation as a result of their abdominal cancers. This follow-up study, also designed by pancreatic cancer expert Dr. Daniel D. Von Hoff in conjunction with scientists affiliated with PharmaCyte Biotech, will be conducted by TD2 in the U.S.
“We are looking forward to the results of this expanded preclinical study of the effectiveness of our pancreatic cancer treatment in reducing the rate of malignant ascites fluid accumulation in the abdomen. If successful, it could quickly lead to a clinical trial in patients with abdominal tumors such as in the case of ovarian cancer, who suffer from this very serious cancer-associated malady,” commented Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech.
Researchers at PharmaCyte Biotech expect that their pancreatic cancer treatment will ultimately prove to be effective in slowing the accumulation of malignant ascites fluid and, thus, reduce the number of withdrawals of the fluid that patients must endure over a given period of time. The hope is to help patients who face accumulation of ascites fluid, which is problematic for patients with an abdominal cancer, because it is painful and can cause breathing and other serious problems. Once ascites fluid gets to a certain level, it must be removed on a regular basis. This procedure in itself is very uncomfortable for patients and costly.
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