Nuvilex Aims for Market Exclusivity with Orphan Drug Status While Eyeing Larger Cancer Market for Cell-in-a-Box Technology
September 05 2014 - 9:00AM
InvestorsHub NewsWire
New York, NY- September 05, 2014 - InvestorsHub
NewsWire - Nuvilex, Inc. (OTCQB:
NVLX) has used the last two weeks to further solidify its
position as a biotechnology firm, and to further its treatment for
advanced pancreatic cancer, as well as, other abdominal
cancers. This summer has been a starting line, of sorts, for
Nuvilex to begin making the case that
Cell-in-a-Box® should help it become a competitor in the cancer
market.
Just this week Nuvilex announced that it has
officially applied for the Orphan Drug Designation with the
European Medicines Agency (EMA) for its treatment for advanced
pancreatic cancer, and that it also plans to apply for the Orphan
Drug status in the US and Australia among other
markets.
The company expects to enter late phase clinical
trials in early 2015 where it will use its treatment of
Cell-in-a-Box combined with low doses of the anticancer drug
ifosfamide, to go head-to-head with Celgene’s (NASDAQ:
CELG) treatment of Abraxane® plus
gemcitabine, the current gold standard for advanced pancreatic
cancer.
In two earlier Phase I/II clinical trials, the
treatment of Cell-in-a-Box/ifosfamide produced better survival
times than both Celgene’s treatment and Eli Lilly’s (NYSE: LLY)
single agent treatment of gemcitabine.
If Nuvilex should receive Orphan Drug status,
the company would enjoy 10 years of marketing exclusivity for the
Cell-in-a-Box/ifosfamide combination along with special assistance
with the development process of the company’s treatment, and
exemptions or reductions in regulatory fees from the
EMA.
The Orphan Drug Designation is awarded to drugs
or treatments for “rare,” life-threatening diseases. In
Europe, a rare disease is defined as one that occurs in less than 5
of every 10,000 people. Pancreatic cancer certainly meets the
criteria in Europe and in the US for that matter, and the treatment
has previously received the Orphan Drug Designation in Europe, so
the company should receive the status.
In another major announcement two weeks ago,
Nuvilex stated that it and Translational Drug Development (TD2)
officially began the first of 4 different pre-clinical studies that
will determine what effect the company’s pancreatic cancer
treatment will have on symptoms associated with abdominal
cancers.
Nuvilex’s first pre-clinical study will test the
success of the Cell-in-a-Box/ifosfamide combination in slowing the
accumulation of malignant ascites fluid in cancer patients.
Malignant ascites is the abnormal accumulation of abdominal fluid
due to the direct effects of cancer, and the fluid itself can
contain cancerous cells, which, in turn, can “seed” at various
places in the abdomen and form new tumors.
According to the National Cancer Institute, the
prognosis for patients with malignant ascites is poor, so this
first study could draw a great deal of attention if
successful.
The World Cancer Research Fund’s latest
statistics regarding what are called “abdominal cancers” show that
annually there are nearly 1.7 million new cases of breast cancer
diagnosed, 1.4 million new cases of colorectal cancer, 952,000 new
cases of stomach cancer, 782,000 new cases of liver cancer, 338,000
new cases of pancreatic cancer and 239,000 new cases of ovarian
cancer. Each of these new cases will potentially need a
treatment for the symptoms they will experience.
These are just a few of the abdominal cancers,
and as should be obvious by the 5.4 million new cases they
represent annually, Nuvilex is potentially developing a treatment
that could compete in what is a huge and virtually untapped
symptoms market.
Given there is only a mean survival time of less
than 4 months for those patients suffering from malignant ascites
(depending on the type of malignancy), and TD2’s reputation for
success, Nuvilex and its investors could see this past summer as
the official start of a very bright future.
About Stock Market Media Group
SMMG is a Research and Content Development IR
firm offering a platform for corporate stories to unfold in the
media with Reports, Interviews and Articles. SMMG is compensated
for Nuvilex content by a third party who reserves the right to buy,
sell or remain neutral on securities after the publication of this
article. To date, SMMG has received total compensation of $110,090
for all created content related to Nuvilex. Additionally, a
principal at SMMG currently owns 200,000 total shares of Nuvilex
issued by the company through a consulting agreement which has
since ended for work unrelated to content development. All shares
have been held for the requisite period under Rule 144 as of April
30, 2014, and are eligible to be sold immediately without further
notice. For more information: www.stockmarketmediagroup.com.
Contact:
Stock Market Media Group
info@stockmarketmediagroup.com