Nuvilex Provides Update on Significance of Austrianova’s cGMP Live-Cell Encapsulation Facility
SILVER SPRING, Md., Dec. 10, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, is pleased to provide an update on the significance of its partner, Austrianova, opening a new, state-of-the-art current Good Manufacturing Practices (cGMP)-compliant live-cell encapsulation facility inside the Thailand Science Park (TSP). This facility will produce the Cell-in-a-Box(R) live-cell encapsulation product that will be the centerpiece for all of Nuvilex’s treatments in human clinical trials.
“The cGMP facility in Thailand will play an integral role in our growth as it enables the production of encapsulated cell products to the highest standards to meet the requirements of the different drug regulators in countries worldwide, particularly territories where we will be conducting clinical trials,” commented Kenneth L. Waggoner, Chief Executive Officer of Nuvilex.
Nuvilex contracted with Austrianova to establish the facility in order to produce the Cell-in-a-Box(R) technology containing the cancer prodrug-activating cells that will be used for Nuvilex’s upcoming trials, including a Phase 2b clinical trial in pancreatic cancer in Australia, clinical trials in the United States related to the intractable pain associated with pancreatic cancer, the accumulation of malignant ascites fluid that results from late-stage pancreatic cancer and other serious abdominal cancers. The facility will also be used to encapsulate insulin-producing cells that will be pivotal for clinical trials of Nuvilex’s treatment for insulin-dependent diabetes.
Prof. Walter H. Gunzburg, Chief Scientific Officer of Nuvilex and Chairman of Austrianova, added, “The first product to be produced from the new cGMP facility will be encapsulated cells for Nuvilex’s pancreatic cancer clinical trial that is planned for Australia. The encapsulation facility is state-of-the-art. It will allow not only the production of batches for clinical trials, but the facility will also be capable of accommodating production of a final product to supply eventual market demand. As well as increased production capacity, the quality of the final product will be greatly enhanced through the development of a new production process. This new process is based entirely on disposable single-use materials, guaranteeing the highest quality of the final product.”
Dr. Brian Salmons, CEO and President of Austrianova, commented on the unique design of the facility saying, “In order to comply with international standards of cGMP, the facility has been designed around a unique custom-built isolation unit which allows the complete production line to be isolated from the operators in a class-A environment. This is the most stringent way to produce a pharmaceutical and guarantees its quality and purity. It is also the first of its kind for a cell encapsulation product and the first of its kind in all of Southeast Asia.”
Dr. Matthias Lohr, the Principle Investigator for the previous Phase 1/2 and Phase 2 pancreatic cancer clinical trials and Chairman of Nuvilex’s newly formed Scientific Advisory Board, said, “We are all very excited by this key development and are eagerly anticipating the late-stage trial for pancreatic cancer as well as for pancreatic cancer-associated ascites fluid accumulation and, in the future, for other cancers. New and effective treatments for pancreatic cancer are desperately needed, and Nuvilex’s treatment for this deadly disease circumvents many of the debilitating side effects associated with more classic chemotherapies.”
The TSP was established by the Ministry of Science and Technology to be the hub for the private sector’s industrial R&D activities. The TSP started its operations in 2002, under the management of the National Science and Technology Development Agency. It is located just outside of Bangkok and has more than sixty companies, four research institutes, three universities and one medical school. The TSP stimulates and manages the flow of knowledge and technology among universities, R&D institutions, companies and markets. It also facilitates the creation and growth of innovation-based companies through incubation and spin-off processes in the most cost-effective manner. For these reasons, Austrianova decided it was the ideal location to set up their science and technology based operations in Southeast Asia.
Nuvilex (NVLX) is a preclinical and 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(R). 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 well-known anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or “cancer-killing” form. In addition, Nuvilex is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. Nuvilex is also developing treatments for cancer based upon chemical constituents of marijuana known as cannabinoids. Nuvilex is examining ways to exploit the benefits of Cell-in-a-Box(R)technology in optimizing the anticancer effectiveness of cannabinoids and cannabinoid-like compounds, while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments. This provides Nuvilex a unique opportunity to develop “green” approaches to fighting deadly cancers, such as those of the pancreas, brain and breast, which affect hundreds of thousands of individuals worldwide every year.
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 or unsuccessful results in clinical trials or flaws or defects regarding its product candidates, 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.
More information about Nuvilex can be found at www.nuvilex.com. It can also be obtained by contacting Investor Relations.
Investor Relations Contacts: Clare Matschullat Blueprint Life Science Group Telephone: 415.375.3340 Ext. 106 firstname.lastname@example.org
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