Nuvilex and Translational Drug Development (TD2) Begin Preparations for US-Based Studies on Symptoms Associated With Pancreat...
May 21 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, together with
Translational Drug Development (TD2) in Scottsdale, Arizona,
preparations have begun for US-based preclinical and then clinical
studies on the unbearable pain and the accumulation of fluid in the
abdominal cavity which are two commonly occurring symptoms
associated with advanced pancreatic cancer.
TD2 will study the effectiveness of Nuvilex's pancreatic cancer
treatment in relieving the unbearable pain and the accumulation of
abdominal fluid known as "ascites." Nuvilex's pancreatic
cancer treatment, which combines the Cell-in-a-Box® live-cell
encapsulation technology with the well-known anticancer drug
ifosfamide, will be studied with the expectation that it can
improve the quality of life of pancreatic cancer patients by
relieving these two chronic symptoms usually associated with the
development of advanced pancreatic cancer. The preclinical
studies are being planned to commence shortly and, if successful,
they will be soon followed by clinical trials in both pain severity
and ascites accumulation.
The studies to be done by TD2 on symptoms associated with the
development of pancreatic cancer are separate and distinct from the
Phase 2b clinical trial that will be conducted in Australia under
the aegis of Clinical Network Services, a leading Contract Research
Organization (CRO) in Australia. The Phase 2b trial will
compare the effectiveness of Nuvilex's pancreatic treatment with
that of the best available therapy (currently Abraxane® in
combination with gemcitabine) on the survival of patients with
advanced pancreatic cancer using median survival time and
percentage of one-year survivors as major study endpoints.
Kenneth L. Waggoner, CEO and President of Nuvilex stated, "TD2,
arguably the most reputable CRO in the US that specializes in
oncology, has committed to undertake these important studies on the
development of severe, untreatable pain and the accumulation of
ascites fluid. These are the two major symptoms associated
with advanced pancreatic cancer. If successful, these studies
will show that our pancreatic cancer treatment can play a
significant role in improving the quality of life of patients
suffering from this dreadful disease." Waggoner continued, "We
are now engaged in a 'two-pronged attack' on pancreatic cancer with
studies by TD2 and the Australian Phase 2b clinical trial, first by
attempting to improve patients' quality of life and second by
attempting to increase the life span of patients with advanced
pancreatic cancer."
Overall, more than 40 percent of patients with pancreatic cancer
experience severe pain, but for those whose cancer is at an
advanced stage this percentage rises to more than 80
percent. The pain due to pancreatic cancer may be very
difficult and, in some cases, impossible to treat
satisfactorily. The most common route to attaining relief from
pancreatic cancer-associated pain is through the use of high-dose
opioid drugs, such as morphine. However, such drugs are
associated with severe side effects. Patients often ask for
alternative methods to relieve their pain. Whether opioids are
used or not, the quality of life of patients with advanced
pancreatic cancer can be severely compromised by their
cancer-associated pain. TD2's studies will be designed to
determine if Nuvilex's pancreatic cancer treatment can reduce the
severity of pancreatic cancer-associated pain.
The accumulation of fluid in the abdominal cavity can occur as a
consequence of several diseases. About 10 percent of all
occurrences of ascites come as a result of cancer. They are
referred to as malignant ascites because they contain cancer cells
derived from a tumor which can then "seed" and form new cancers.
Individuals with breast cancer, cancers of the
gastrointestinal tract, ovarian, uterine or pancreatic cancer are
most likely to experience malignant ascites. The aim of TD2's
studies in this area is to determine if Nuvilex's pancreatic cancer
treatment can slow the accumulation of ascites fluid in patients
with advanced pancreatic cancer.
About Nuvilex Nuvilex (OTCQB:NVLX) is a
clinical stage biotechnology company focused on developing and
patented technology 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 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 working towards
clinical trials associated with the symptoms of advanced pancreatic
cancer and other abdominal cancers as well as diabetes.
About Translational Drug Development (TD2)
Translational Drug Development (TD2) is an oncology drug
development company that has facilities for the preclinical and
clinical testing of candidate cancer drugs and treatments, as well
as expertise in regulatory affairs. For preclinical studies, TD2
has more than 200 established models of human cancer. TD2 has
performed early-mid phase clinical studies on over 400 new
anticancer agents and has worked with more than 350 biotech and
pharmaceutical companies worldwide. TD2 has an unmatched access to
patients for clinical trials. Please visit www.td2inc.com.
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
Phone: 702.434.8692
mmolinarofc@aol.com
Dillon Heins
CorProminence, LLC
Phone: 218.839.9051
dillonh@corprominence.com
Media Contact:
Jules Abraham
JQA Partners, LLC
Phone: 917.885.7378
jabraham@jqapartners.com