Nuvilex Readies Pancreatic Cancer Treatment for Expanded Phase II Clinical Trials

Nuvilex

announced today it is aggressively engaging the steps necessary to use its encapsulated cell technology for pancreatic cancer in expanded Phase II clinical trials in the United States, Europe and Australia. The Company's objective is to have a protocol submitted to the regulatory agencies in these countries as quickly as possible. In conjunction with SG Austria, the world's leading cell encapsulation technology company based in Singapore, Nuvilex has already activated our plan for rapid entry into expanded pancreatic cancer clinical trials. Necessary funding to initiate this phase of the study has been secured and the principals from both companies are working in close harmony to develop, implement, and oversee plans for the new clinical trials. Together with SG Austria's team, we have been refining the technology utilized in the previous Phase I/II clinical trials. This advanced technology will result in having cells capable of converting modern cancer drugs to high concentrations directly at the tumor site. This development should result in even better overall response rates than seen in the original trial. In addition, these advances should also serve to improve other results previously observed including tumor shrinkage. It is anticipated the improved therapy will increase the median survival of advanced pancreatic cancer patients. Once the newly-refined cells are grown in large numbers, we will have sufficient cells necessary for the clinical trials. Plans for the clinical studies are already being prepared for submission and review by the critical regulatory agencies in the U.S., Europe, and Australia. Regulatory authorities in Europe had previously indicated this encapsulated cell therapy for pancreatic cancer qualifies for “orphan drug” status which should facilitate and accelerate the entire approval process, helping to bring this phase of testing to fruition more rapidly.