Nuvilex Partners With CRO Translational Drug Development For US-Based Studies Of Pancreatic Cancer Symptoms

Nuvilex announced in a press release it has partnered with Translational Drug Development (TD2) for U.S.-based preclinical and clinical studies on pancreatic cancer symptoms. TD2, a contract research organization (CRO) will study Nuvilex’s pancreatic cancer treatment on pain and the fluid accumulation in the abdominal cavity — common symptoms in advanced pancreatic cancer. Preclinical studies are to begin soon, followed by clinical trials. A separate study lead by Clinical Network Services, a CRO, will be conducted in Australia.

Kenneth L. Waggoner, CEO and President of Nuvilex said, "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."

Nuvilex's Pancreatic Cancer Treatment

Nuvilex's pancreatic cancer treatment is intended for pain and abdominal fluid accumulation, known as ascites. The treatment is a formulation of Cell-in-a-Box live-cell encapsulation technology and the cancer drug ifosfamide. Live-cell encapsulation technology encloses living cells in cocoons, which contain pores for nutrients to enter and for waste products to leave. The encapsulated cells are implanted into the cancer patient and continue to function and dispense treatment for long periods. Nuvilex’s cell encapsulation platform is intended for multiple types of treatments.

TD2 Trials

TD2 investigators hope to improve the symptoms of pancreatic cancer thereby improving the patient’s quality of life. Pancreatic cancer patients experience pain but those with advanced cancer experience severe or unbearable pain. Treatment options are limited for this type of pain; morphine and other high-dose opioid drugs are used. These powerful drugs have serious side effects and patients often request other kinds of treatment. The endpoint of the trials is a reduction in pain severity. The endpoint in the fluid accumulation trials is to slow the accumulation of ascites. These malignant ascites contain cancer cells that can spread and grow new tumors. Reducing fluid may result in fewer cancer growths. 

Clinical Network Services

Clinical Network Services will conduct a Phase IIb clinical trial in Australia. It will compare Nuvilex’s treatment with other therapies. Currently the best available treatment is Abraxane in combination with gemcitabine. Endpoints are median survival time and percentage of one-year survivors. In a press release, the company stated that it will also provide consultancy in Nuvilex’s global regulatory strategy, which is focused on Orphan Drug Designation from the FDA, the EMA, and Australian TGA.