Nuvilex Reports Successful Establishment of Initial Research Cell Bank to Support Late-Phase Pancreatic Cancer Clinical Trial
SILVER SPRING, Md. and VIENNA, Austria, Feb 15, 2013 (GLOBE NEWSWIRE via COMTEX) --
Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology and clinical stage provider of natural products and cell and gene therapy solutions for the treatment of diseases, announced today its subsidiary, Austrianova Singapore Pte. Ltd. (ASPL) has reported the successful establishment of a research "cell bank" that will ultimately be used to obtain the numbers of cells necessary for conducting the Company's late-phase clinical trials in patients with advanced, inoperable, pancreatic cancer.
The research cell bank was established by ViruSure GmbH, an Austrian Contract Research Organization located in Vienna, Austria. The genetically augmented human cells in the cell bank are the same as those used in the two successfully completed mid-phase clinical trials in advanced non-resectable pancreatic cancer patients previously reported by Nuvilex.
ViruSure is an important international biosafety company in the biotechnology community with substantial expertise in cell culture, virus, prion, and other infectious agent testing, as well as cell growth and assessment capabilities. ViruSure assessed the purity and sterility of our cells. Before the cell bank was established, the cells were tested and shown to be free of contamination by mycoplasma, a type of bacteria that can be toxic to humans. The validation that the cells in the cell bank are "mycoplasma-free" is a prerequisite for further expansion of the cell line required for Nuvilex's late-phase clinical studies in advanced pancreatic cancer that are currently in preparation. Nuvilex is proud to announce that completion of this stage successfully showed the cells were mycoplasma-free.
Since that initial assessment, ViruSure has been carrying out the amplification of these same cells on a "fast track" basis. These cells will ultimately be used for encapsulation and subsequently implanted in patients for the treatment of advanced, inoperable pancreatic cancer.
"We are excited that the initial steps required for the commencement of additional clinical trials of our encapsulated cell therapy in advanced pancreatic cancer have been made possible through the establishment of this cell bank," said Dr. Brian Salmons, CEO of ASPL.
In discussions with ViruSure they stated, "We are pleased to be involved in achieving this important milestone for Austrianova Singapore and Nuvilex that will enable the future development and evaluation of their treatment for pancreatic cancer." The ViruSure state-of-the-art facilities for amplifying cells under GLP (Good Laboratory Practices) conditions and their capabilities in testing for contaminants arena were contributing factors in it being chosen to carry out this activity.
Dr. Robert F. Ryan, President and CEO of Nuvilex said, "We are very pleased by the thoroughness with which ViruSure has completed the first assessment and are now carrying out the amplification of these important cells for use in cancer treatments. The professionalism shown by both ViruSure and ASPL and the timely fashion in which this important milestone was achieved are extremely gratifying. Nuvilex is committed to advancing this project through the necessary additional clinical trials to the market place so that our novel pancreatic cancer treatment can be made available for the treatment of this devastating disease."
Nuvilex, Inc. (OTCQB:NVLX) has been a provider of all-natural products for many years. The company has been expanded to increase its natural product-based footprint and will continue to make advances as we move forward. We are an international biotechnology provider of live, therapeutically valuable, encapsulated cells and services for research and medicine. New developments by our company and subsidiaries will be substantial as we have been working on many fronts to move us forward. Our company's offerings will ultimately include cancer, diabetes and other treatments using the Company's natural product knowledge, product base, cell and gene therapy expertise, and live-cell encapsulation technology in addition to other new products currently under development.
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