SILVER SPRING, Md., April 10, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, reported today that it has signed a Master Services Agreement with ViruSure GmbH, located in Vienna, Austria, to develop and maintain Master, Working and End of Production Cell Banks. These cell banks are necessary steps in the production of the cells to be encapsulated using the Cell-in-a-Box® technology for Nuvilex's Phase 2b clinical trials in advanced, inoperable pancreatic cancer to be conducted in Australia.
"ViruSure has previous experience in handling the exact cell line that will be used in our Phase 2b clinical trials, which was a major factor in Nuvilex selecting ViruSure for this important step in our preparations for these trials," said Kenneth L. Waggoner, CEO and President of Nuvilex. "This decision was further supported by our on-site inspection of the ViruSure facilities and the excellent historical relationships between ViruSure's key personnel with our partners at Austrianova. ViruSure has years of experience in producing and maintaining cell banks and is an industry leader in this arena."
"We are delighted to be partnering with Nuvilex on such an important project and in helping to bring this much needed therapy for such a devastating disease as pancreatic cancer to the clinic," stated Andy Bailey, CEO and co-founder of ViruSure.
The cells that will make up the Master, Working and End of Production Cell Banks will be those that convert the anticancer drug ifosfamide into its cancer-killing form. These therapeutic cells will be shipped to ViruSure for propagation. First a Master Cell Bank will be established where aliquots of cells will be stored frozen. Cells from the Master Cell Bank will be propagated to make up the large number of cells that will comprise the Working Cell Bank. Ultimately, cells from the Working Cell Bank will be encapsulated using the Cell-in-a-Box® live cell encapsulation technology. An End of Production Cell Bank will then be made from the final product for quality control purposes. The encapsulated cell product, together with ifosfamide, forms Nuvilex's treatment for pancreatic cancer.
Nuvilex (OTCQB: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 involved in preclinical and clinical trials related to other aspects of pancreatic cancer.
ViruSure is a biotech company specializing in the virus and prion safety testing of biopharmaceutical products. ViruSure offers contract testing services and a wealth of expertise to ensure customers meet all relevant pathogen safety testing requirements. ViruSure also produces cell banks for various purposes, including clinical trials. The rigorous regulatory compliant standards to which ViruSure works are an essential component of the safety testing for biopharmaceutical products, including cell-based therapies such as Cell-in-a-Box®. All testing services are supported by a risk based quality management system. For additional information on ViruSure see www.virusure.com.
This press release may contain forward-looking statements regarding Nuvilex and its future events and results that involve inherent risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "plan" and similar expressions, as they relate to Nuvilex or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of Nuvilex, that could cause actual results to differ materially from those set forth in the forward-looking statements include Nuvilex's ability to continue as a going concern, delays in clinical trials or flaws or defects regarding its products, changes in relevant legislation or regulatory requirements, uncertainty of protection of Nuvilex's intellectual property and Nuvilex's continued ability to raise capital. Nuvilex does not assume any obligation to update any of these forward-looking statements.
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