SILVER SPRING,
MD - November 07, 2014 - Investorshub Newswire – Nuvilex,
Inc. (OTCQB:
NVLX), a clinical-stage biotechnology company providing cell
and gene therapy solutions for the treatment of diseases, announced
today that it has submitted, through its subsidiary Nuvilex
Australia, an application to the Therapeutic Goods Administration
(TGA) in Australia to obtain the Orphan Drug Designation for its
pancreatic cancer treatment. This submission follows similar
applications to the United States Food and Drug Administration and
the European Medicines Agency in the European Union (EU). Like
those in the U.S. (7 years) and the EU (10 years), granting of the
Orphan Drug Designation carries with it a significant period of
marketing exclusivity. In Australia this period is 5
years.
Nuvilex’s CEO and
President, Kenneth L. Waggoner, commented, “The application for the
Orphan Drug Designation in Australia is the third such application
made to the drug regulatory authorities in major areas of the
world. In order for the Orphan Drug Designation to be granted to a
particular drug or treatment, the target disease must be considered
life-threatening and ‘rare.’ Pancreatic cancer, no matter where it
occurs in the world, is undoubtedly life-threatening and, in our
opinion, its prevalence in Australia classifies it as a rare
disease. It is expected that this application to the TGA will be
reviewed relatively quickly, and we may have a decision on it
before the end of the year.”
Nuvilex’s
pancreatic cancer treatment consists of implanting living cells
that have been encapsulated in pin-head sized, cellulose-based,
protective “cocoons” through the use of the proprietary
Cell-in-a-Box® technology, followed by the
administration of low doses of the anticancer prodrug ifosfamide.
Ifosfamide is a drug that must be converted into its
“cancer-killing” form for it to be effective. The cells that are
encapsulated are efficient and effective at carrying out this
conversion. By placing these encapsulated ifosfamide-activating
cells in proximity to the pancreatic cancer, the anticancer effects
of the drug are optimized. In addition, as shown in early-phase
clinical trials, because low doses of the anticancer drug are used
the side effects from it are greatly reduced in severity and the
treatment is well tolerated by the patients undergoing this novel
treatment.
Mr. Waggoner
continued, “As with the applications for the Orphan drug
Designation in the U.S. and the EU, we are extremely grateful to
our colleagues at Clinical Network Services (CNS) for their
assistance in the preparation of this Australian submission. In
particular, the services of Dr. Natalie Thomas in the preparation
and submission of this application were invaluable. CNS, one of
Australia’s leading Contract Research Organizations, has been
contracted by Nuvilex to conduct its Phase 2b pancreatic cancer
clinical trial in that country.”
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 well-known
anticancer prodrug ifosfamide, together with encapsulated live
cells, which convert ifosfamide into its active or "cancer-killing"
form. Nuvilex is also working towards improving the quality of life
for patients with advanced pancreatic cancer and on treatments for
other types of solid cancerous tumors. In addition, Nuvilex
is 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 such cannabinoids against cancers, 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 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 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:
Clare Matschullat
Blueprint Life Science
Group
Telephone: 415.375.3340 Ext. 106
Cmatschullat@bplifescience.com