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news.Nuvilex has announced that, together with Translational Drug Development (TD2) in Scottsdale, Arizona, preparations have begun for US-based preclinical and then clinical studies on the unbearable pain and the accumulation of fluid in the abdominal cavity which are two commonly occurring symptoms associated with advanced pancreatic cancer.
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TD2 will study the effectiveness of Nuvilex’s pancreatic cancer treatment in relieving the unbearable pain and the accumulation of abdominal fluid known as ‘ascites’.
Nuvilex’s pancreatic cancer treatment, which combines the Cell-in-a-Box(R) live-cell encapsulation technology with the well-known anticancer drug ifosfamide, will be studied with the expectation that it can improve the quality of life of pancreatic cancer patients by relieving these two chronic symptoms usually associated with the development of advanced pancreatic cancer.
The preclinical studies are being planned to commence shortly and, if successful, they will be soon followed by clinical trials in both pain severity and ascites accumulation.
The studies to be done by TD2 on symptoms associated with the development of pancreatic cancer are separate and distinct from the Phase 2b clinical trial that will be conducted in Australia under the aegis of Clinical Network Services, a leading Contract Research Organization (CRO) in Australia.
The Phase IIb trial will compare the effectiveness of Nuvilex’s pancreatic treatment with that of the best available therapy (currently Abraxane(R) in combination with gemcitabine) on the survival of patients with advanced pancreatic cancer using median survival time and percentage of one-year survivors as major study endpoints.
Nuvilex CEO and president Kenneth L Waggoner said that TD2, arguably the most reputable CRO in the US that specializes in oncology, has committed to undertake these important studies on the development of severe, untreatable pain and the accumulation of ascites fluid.
"These are the two major symptoms associated with advanced pancreatic cancer. If successful, these studies will show that our pancreatic cancer treatment can play a significant role in improving the quality of life of patients suffering from this dreadful disease. We are now engaged in a ‘two-pronged attack’ on pancreatic cancer with studies by TD2 and the Australian Phase 2b clinical trial, first by attempting to improve patients’ quality of life and second by attempting to increase the life span of patients with advanced pancreatic cancer," Waggoner added.
TD2’s studies will be designed to determine if Nuvilex’s pancreatic cancer treatment can reduce the severity of pancreatic cancer-associated pain.
The aim of TD2’s studies in this area is to determine if Nuvilex’s pancreatic cancer treatment can slow the accumulation of ascites fluid in patients with advanced pancreatic cancer.