SILVER SPRING, Md., May 21, 2014 — Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today 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.
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 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 2b trial will compare the effectiveness of Nuvilex’s pancreatic treatment with that of the best available therapy (currently Abraxane 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.
Kenneth L. Waggoner, CEO and President of Nuvilex stated, “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.” Waggoner continued, “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.”
Overall, more than 40 percent of patients with pancreatic cancer experience severe pain, but for those whose cancer is at an advanced stage this percentage rises to more than 80 percent. The pain due to pancreatic cancer may be very difficult and, in some cases, impossible to treat satisfactorily. The most common route to attaining relief from pancreatic cancer-associated pain is through the use of high-dose opioid drugs, such as morphine. However, such drugs are associated with severe side effects. Patients often ask for alternative methods to relieve their pain. Whether opioids are used or not, the quality of life of patients with advanced pancreatic cancer can be severely compromised by their cancer-associated pain. TD2’s studies will be designed to determine if Nuvilex’s pancreatic cancer treatment can reduce the severity of pancreatic cancer-associated pain.
The accumulation of fluid in the abdominal cavity can occur as a consequence of several diseases. About 10 percent of all occurrences of ascites come as a result of cancer. They are referred to as malignant ascites because they contain cancer cells derived from a tumor which can then “seed” and form new cancers. Individuals with breast cancer, cancers of the gastrointestinal tract, ovarian, uterine or pancreatic cancer are most likely to experience malignant ascites. 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.
Nuvilex (NVLX) is a clinical stage biotechnology company focused on developing and patented technology preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology known as Cell-in-a-Box. This unique and will be used as a platform upon which treatments for several types of cancer, including advanced inoperable pancreatic cancer, and diabetes are being built. Nuvilex’s treatment for pancreatic cancer involves the widely used anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or “cancer-killing” form. Nuvilex is also working towards clinical trials associated with the symptoms of advanced pancreatic cancer and other abdominal cancers as well as diabetes.
About Translational Drug Development (TD2)
Translational Drug Development (TD2) is an oncology drug development company that has facilities for the preclinical and clinical testing of candidate cancer drugs and treatments, as well as expertise in regulatory affairs. For preclinical studies, TD2 has more than 200 established models of human cancer. TD2 has performed early-mid phase clinical studies on over 400 new anticancer agents and has worked with more than 350 biotech and pharmaceutical companies worldwide. TD2 has an unmatched access to patients for clinical trials. Please visit www.td2inc.com.