FDA Grants Orphan Drug Designation to Nuvilex for Pancreatic Cancer Treatment
23 December 2014 - 12:30AM
InvestorsHub NewsWire
SILVER SPRING, MD
- December 22, 2014 - InvestorsHub NewsWire - Nuvilex, Inc.
(OTCQB:
NVLX), a clinical-stage biotechnology company providing cell
therapy solutions for the treatment of diseases, today announced
that the U.S. Food and Drug Administration (FDA) has granted
Nuvilex orphan drug designation for its pancreatic cancer
treatment. Nuvilex’s pancreatic cancer treatment combines Nuvilex’s
patented and proprietary cellulose-based encapsulation technology,
known as Cell-in-a-Box®, with the cancer prodrug
ifosfamide and encapsulated live cells that convert the prodrug
into its cancer-killing form. These capsules are placed as close to
the cancerous tumor as possible to enable the delivery of the
highest levels of the cancer-killing drug at the source of the
cancer. This “targeted chemotherapy” has proven remarkably
effective in past clinical trials.
“Receiving orphan drug designation by the FDA represents a
significant milestone in the development of our pancreatic cancer
treatment. This achievement is a very important one, both for
Nuvilex and our partner Austrianova. It not only facilitates the
future development of Nuvilex’s pancreatic cancer treatment, but
also serves to validate the Cell-in-a-Box® technology.”
stated Kenneth L. Waggoner, Chief Executive Officer of Nuvilex.
Nuvilex is currently preparing for a Phase 2b clinical trial in
advanced pancreatic cancer (the orphan indication) in Australia to
gain regulatory approval from agencies like the FDA for Nuvilex’s
targeted chemotherapy of pancreatic cancer. Nuvilex’s clinical
trial is planned to commence in 2015.
To access the FDA’s official listing of Nuvilex receiving the
Orphan Drug Designation, use this link: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/oopd_results_2.cfm?index_number=457014.
Orphan drug designation in the U.S. is given to drugs or treatments
for “rare,” life-threatening diseases. In the U.S., a rare disease
is defined as one that is diagnosed in less than 200,000 people in
the U.S. In addition, in the U.S. pancreatic cancer can be
classified as a life-threatening disease because, even with the
best available chemotherapy, patients with advanced pancreatic
cancer are destined to live less than one year on average and the
5-year survival rate is less than seven percent.
Receiving orphan drug designation for Nuvilex’s pancreatic cancer
treatment carries with it up to 7 years of marketing exclusivity in
the U.S. In addition, special assistance from the FDA in the
development of Nuvilex’s treatment for pancreatic cancer and
exemptions or reductions in regulatory fees and taxes can accompany
the designation.
About Nuvilex
Nuvilex 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 well-known
anticancer prodrug ifosfamide, together with encapsulated live
cells, which convert ifosfamide into its active or "cancer-killing"
form. In addition, Nuvilex is working towards improving the quality
of life for patients with advanced pancreatic cancer and on
treatments for other types of solid cancerous tumors. Nuvilex is
also developing treatments for cancer based upon chemical
constituents of marijuana known as cannabinoids. Nuvilex is
examining ways to exploit the benefits of 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 the rare 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 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, could cause actual results to differ
materially from those set forth in the forward-looking statements.
They 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 these 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:
Jamien Jones
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 103
jjones@bplifescience.com