Nuvilex Contracts With Clinical Network Services Pty Ltd for Late-Phase Clinical Trials in Pancreatic Cancer
April 15 2014 - 9:00AM
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.
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 www.clinical.net.au
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
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
mmolinarofc@aol.com
Dillon Heins
CorProminence, LLC
Ph: 218.839.9051
dillonh@corprominence.com
Media Contact:
Jules Abraham
JQA Partners, LLC
Ph: 917.885.7378
jabraham@jqapartners.com