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Nuvilex Adds World Renowned Oncologist and Gastroenterologist to Play Major Role in Late Phase Clinical Trial

SILVER SPRING, Md., May 1, 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 world renowned oncologist and gastroenterologist Professor Dr. Matthias Lohr of the famed Karolinska Institute in Stockholm, Sweden, has agreed to play a major role in Nuvilex’s Phase 2b clinical trial in pancreatic cancer to be conducted in Australia, as well as other clinical studies and trials in which Nuvilex will be involved. Dr. Lohr served as Principal Investigator for the previous Phase I/II clinical trials that employed Nuvilex’s pancreatic cancer treatment. 

“Dr. Lohr’s reputation as a leading oncologist, as well as his previous experience and belief in Nuvilex’s Cell-in a-Box/ifosfamide combination as a treatment for patients with advanced pancreatic cancer, make his input into our clinical trial invaluable,” said Kenneth L. Waggoner, CEO and President of Nuvilex. “Because he was Principal Investigator in the two previous clinical trials with the Cell-in-a-Box/ifosfamide combination in patients with pancreatic cancer, Nuvilex now has one of the world’s top experts on the clinical use of this combination who will play a major role in this most important phase of its development as a treatment for one of the deadliest forms of cancer.” 

Dr. Lohr will fulfill a pivotal role in assisting the Nuvilex team in designing and conducting Nuvilex’s Phase 2b clinical trial in advanced pancreatic cancer. In this two-armed clinical trial, Nuvilex’s pancreatic cancer treatment (a combination of the proprietary Cell in-a-Box live-cell encapsulation technology and the well-known cancer drug ifosfamide), which has already proven effective in Phase I/II clinical trials, will be compared “head-to-head” with the “gold standard” of care for pancreatic cancer — Abraxane plus gemcitabine. 

As Principal Investigator for the two previously successful early phase clinical trials with the Cell-in-a-Box/ifosfamide combination, Dr. Lohr worked closely with Clinical Network Services, the same Clinical Research Organization (CRO) in Australia recently retained by Nuvilex to manage its future Phase 2b clinical trial. In the early clinical trials, improvements in both median survival and one-year survival rate were seen with the Cell-in-a-Box/ifosfamide combination as compared to historical data for Gemzar (gemcitabine), the best available treatment for the disease at the time those clinical trials were conducted. In addition, the results of those clinical trials were achieved with no meaningful treatment-related side effects as compared to the serious side effects reported with Gemzar-treated patients. 

In commenting on his involvement in the Phase 2b trial, Dr. Lohr stated, “It is exciting to see that Nuvilex has mastered some of the challenges that the Cell-in-a-Box technology had remaining when we conducted the first clinical trials. It is, of course, with great pleasure that I see our original concept brought to life again. I am very much looking forward to the upcoming clinical trial.” 

Some of the areas of the Phase 2b trial in which Dr. Lohr will have a significant role include supporting Nuvilex in collecting information for the design of the clinical trial, writing scientific reports and other documents needed for Ethics Committee approvals for the trial, assessing protocols and procedures to be carried out during the clinical trial, providing advice to clinical personnel conducting the trial and consulting with and providing advice to Nuvilex on a host of issues related to the clinical trial. In addition, Dr. Lohr will be consulting for Nuvilex in connection with additional clinical trials Nuvilex is planning that are associated with pancreatic cancer-related symptoms and other abdominal cancers. 

Dr. Lohr currently serves as Professor of Gastroenterology and Hepatology at the Karolinska Institute and as Senior Consultant, Gastrocentrum, Karolinska University Hospital. He received the Dr. med. (MD equivalent) degree from the University of Hamburg (Germany) in 1986 and the Dr. med. habil. (PhD equivalent) degree from the University of Rostock (Germany) in 1996. His postdoctoral work during the late 1980s included time as Resident in Pathology at the University of Hamburg and as Postdoctoral Research Fellow at the Scripps Clinic and Research Foundation in La Jolla, California. Dr. Lohr became Assistant Professor in Medicine at the University of Rostock in 1996, served as Professor of Molecular Gastroenterology, University of Heidelberg from 2000-2007, as Deputy Chairman of the Department of Medicine at the same institution from 2001-2007 and as Head of the Molecular Gastroenterology Unit at the German Cancer Research Center from 2002-2009. In addition, Dr. Lohr has held Visiting Professor positions at the European Institute of Oncology in Milan (since 2003) and on the Medical Faculty at the University of Belgrade (since 2005). 

Dr. Lohr has received numerous honors and awards including those from the European Pancreatic Club, the Juvenile Diabetes Foundation International and the American Gastroenterology Association. He also received an award for translational research in pancreatic carcinoma from the Hirshberg Foundation, the Innovations award of Stiftung Familie Klee (Frankfurt), the prestigious Bengt Ihre Medal from the Swedish Society of Medicine and the Presidential lecture and award from the German Gastrointestinal Society. He has served in various capacities with numerous gastroenterology/oncology organizations throughout Europe and as consultant to biotech and pharmaceutical companies. Dr. Lohr has authored more than 120 papers in peer-reviewed scientific journals. 

About Nuvilex: 

Nuvilex (NVLX) is a clinical stage biotechnology company focused on developing and 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 patented technology 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.