SILVER SPRING, Md., April 15, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has contracted Clinical Network Services Pty Ltd (CNS), a fully integrated drug development company based in Australia, New Zealand and the United Kingdom, to handle every aspect of Nuvilex's late-phase clinical trials in pancreatic cancer as Nuvilex's Contract Research Organization (CRO). The trials, which will focus on treatment for advanced stage pancreatic cancer, will involve Nuvilex's pancreatic cancer treatment (a combination of the proprietary "Cell in-a-Box®" live-cell encapsulation technology and the cancer drug ifosfamide) which has already proved effective in early stage trials.
"The work we are embarking upon with CNS is an important milestone for Nuvilex, as it represents the next step in proving the value of our Cell-in-the-Box® technology and the potential of a better treatment for pancreatic cancer," said Kenneth L. Waggoner, CEO and President of Nuvilex. "CNS's rich history and familiarity with our treatment from the previous Phase 1/2 clinical trials, as the CRO in charge of those early stage trials, will greatly facilitate the preparations for and overall conduct of the Australian trials and bring us closer to our goal of providing patients with an improved treatment option for this devastating disease."
CNS will provide a full complement of services to Nuvilex, including planning, managing, coordinating and conducting Nuvilex's Phase 2b clinical trials in pancreatic cancer patients to be carried out in Australia. In addition to the clinical trials, CNS will immediately provide consulting and management services to Nuvilex as part the implementation of Nuvilex's global regulatory strategy, including applications for Orphan Drug Designation from the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
Russell Neal, the Managing Director of CNS, commented, "We are delighted to be supporting Nuvilex in developing the Cell-in-a-Box® technology for the treatment of pancreatic cancer. We are excited to be working towards initiating the Phase 2b study in Australia and providing global regulatory support for this ground breaking therapy."
The Phase 2b clinical trials in Australia will build upon the results of two independent single-arm Phase 1/2 trials conducted with the pancreatic cancer treatment licensed by Nuvilex from its partner Austrianova that consists of the combination of the proprietary live-cell encapsulation technology known as Cell-in-a-Box® and the well-known cancer drug ifosfamide. Current plans are that the Australian trials will be a two-armed study in which Nuvilex's treatment will be compared "head-to-head" with the current "gold standard" for the treatment of advanced pancreatic cancer, namely, the combination of gemcitabine and Abraxane® developed by Celgene and approved by the FDA in September, 2013.
The clinical trials in Australia are entirely distinct from and complementary to the recently announced preclinical and clinical studies to be performed by Translational Drug Development (TD2) in the United States. The Australian trials will concentrate upon survival rates and other common clinical trial parameters, whereas the studies in the United States by TD2 will deal with syndromes associated with pancreatic cancer and may lead to accelerated interaction with the FDA.
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 trials associated with other aspects of pancreatic related treatments.
About Clinical Network Services:
Clinical Network Services (CNS) Pty Ltd is an Australian, New Zealand and United Kingdom CRO offering integrated development services to virtual, small and medium sized Biotech companies in the planning, implementation and delivery of Phase 1 and 2 trials and beyond. CNS offers a unique service where it integrates "BioDesk," an intelligent product development planning and regulatory affairs service with CNS's committed, highly experienced regional clinical operations team. The CNS "Regional Advantage" is driven by CNS's extremely pragmatic regulatory environment that makes it possible for CNS clients to enter the clinic quickly, without the need for prior regulatory agency approval. Specifically, "BioDesk" works closely with CNS clients to design, implement and manage manufacturing and preclinical plans that are mindful of commercial timelines and budgets, allowing swifter go/no go decisions for CNS clients and their investors. With operations across Australia and New Zealand, CNS makes use of its close relationships with key opinion leaders, world leading clinical facilities and globally respected clinical trial units across a wide variety of therapeutic indications. The service offerings by CNS include product development, regulatory affairs planning and development, clinical planning, study start up, monitoring, project management, data management, biostatistics, pharmacometrics, medical consulting/monitoring, medical writing, bioanalytical services and safety reporting. Further information on CNS can be found at www.clinical.net.au
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.
More information about Nuvilex can be found at www.nuvilex.com. It can also be obtained by contacting Investor Relations Contacts and Media Contact.
CONTACT: Investor Relations Contacts: Marlin Molinaro Marmel Communications, LLC Ph: 702.434.8692 email@example.com Dillon Heins CorProminence, LLC Ph: 218.839.9051 firstname.lastname@example.org Media Contact: Jules Abraham JQA Partners, LLC Ph: 917.885.7378 email@example.com