Nuvilex Applies to FDA for Orphan Drug Designation for its Cell-in-a-Box® Treatment for Pancreatic Cancer
October 13 2014 - 9:00AM
InvestorsHub NewsWire
SILVER SPRING,
MD - October 13, 2014 - InvestorsHub NewsWire - Nuvilex, Inc.
(OTCQB:
NVLX), a clinical-stage biotechnology company developing cell
therapy solutions for the treatment of diseases, announced today
that it has submitted an application to the U.S. Food and Drug
Administration (FDA) for Orphan Drug Designation for its
Cell-in-a-Box® treatment for pancreatic cancer. If
granted, Orphan Drug Designation in the United States will provide
Nuvilex special development and commercial assistance from the FDA,
including a 7 year period of marketing exclusivity. This latest
submission of Nuvilex’s pancreatic cancer treatment for the Orphan
Drug Designation follows the application Nuvilex recently made to
the European Medicines Agency (EMA) in September, 2014.
Nuvilex’s
pancreatic cancer treatment combines the Cell-in-a-Box®
cellulose-based live cell encapsulation technology with low doses
of the anticancer “prodrug” ifosfamide to provide “targeted
chemotherapy” to patients suffering from pancreatic cancer. The
cells that are enclosed in pin-head-sized capsules during the
Cell-in-a-Box® encapsulation process convert ifosfamide
into its cancer-killing form at or near the site of the tumor to
increase the efficiency and effectiveness of a patient’s
treatment.
“Submission for
Orphan Drug Designation in the U.S. is the next logical step for
the development of Nuvilex’s pancreatic cancer treatment, and we
look forward to hearing back from the FDA regarding our
application,” commented Kenneth L. Waggoner, Nuvilex’s Chief
Executive Officer.
Orphan Drug
Designation in the United States is given to drugs or treatments
for “rare,” life-threatening diseases. In the United States a rare
disease is defined as one that is diagnosed in less than 200,000
individuals per year. According to incidence estimates, the
prevalence of pancreatic cancer in the United States is less than
50,000 cases annually. As in Europe, there is no doubt that
pancreatic cancer is a life-threatening disease in the United
States. Even with the best available chemotherapy, those with
advanced pancreatic cancer are destined to live less than one year
on average, and the 5-year survival rate is less than 7%. On these
bases alone, Nuvilex’s pancreatic cancer treatment qualifies for
consideration by the FDA for Orphan Drug
Designation.
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 low doses of the
anticancer prodrug ifosfamide and encapsulated live cells that
convert ifosfamide into its active or "cancer-killing" form. In
concert with these efforts, Nuvilex is working towards improving
the quality of life for patients with advanced pancreatic cancer
and on treatments for other types of cancer using the
Cell-in-a-Box® technology. In addition, Nuvilex
is developing cancer treatments
based upon chemical constituents of Cannabis, known as
cannabinoids. To do so, Nuvilex is examining ways to exploit the
benefits of the Cell-in-a-Box® technology in optimizing
the anticancer effectiveness of cannabinoids, 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.
Safe
Harbor
This press release
may contain forward-looking statements regarding Nuvilex and its
future plans 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 its 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
cmtschullt@bplifescience.com