Nuvilex Contracts With Clinical Network Services Pty Ltd for Late-Phase Clinical Trials in Pancreatic Cancer

Nuvilex Contracts With Clinical Network Services Pty Ltd for Late-Phase
Clinical Trials in Pancreatic Cancer

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

"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.

About Nuvilex:

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

Safe Harbor:

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 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
         Dillon Heins
         CorProminence, LLC
         Ph: 218.839.9051
         Media Contact:
         Jules Abraham
         JQA Partners, LLC
         Ph: 917.885.7378

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