In late January, those with advanced stage pancreatic cancer
received some good news when Celgene, Corp (NASDAQ: CELG) announced the results
of its large scale phase III trial at the 2013 Gastrointestinal Cancers
Symposium of the American Society of Clinical Oncology (ASCO), held in San
Pancreatic cancer is
difficult to diagnose and treat until it is at an advanced
of patients with advanced, inoperable pancreatic cancer is usually only several
weeks or a few months. The National
Cancer Institute estimates that, in the U.S. alone, 45,220 new cases of
pancreatic cancer will be diagnosed in 2013 and that 38,460 deaths will be
attributable to the dreaded disease this year.
But, like two prize
fighters, a pair of biotech companies is steadfast in the battle against a
common enemy – pancreatic cancer. Both have
presented astounding results that leave one to think, we may be extremely close
to turning the corner in the fight against this brutal disease.
and Goliath Strengthen Hand vs. Opponent
One is a Goliath in the biotech world, leaving the other to
take on the role of David as a much smaller biotech, but for those who suffer
with pancreatic cancer, they don’t see size, they see results. And, the results these two companies are
delivering are providing much needed hope to patients, interestingly though,
from two completely different approaches.
Goliath in this case is Celgene Corp. The company presented its results from a large
phase III trial it sponsored which included 861 patients across 151 clinical sites. Celgene’s trial compared nanoparticle-albumin-bound
(nab)-paclitaxel (Taxol®), or Abraxane®, plus gemcitabine (Gemzar®) to
gemcitabine alone in patients with advanced, inoperable pancreatic cancer.
Eli Lilly’s (NYSE: LLY) blockbuster drug, Gemzar is the only
drug approved by the FDA as a single agent for the treatment of advanced,
inoperable pancreatic cancer and the drug is considered the “gold standard” by
Dr. Daniel Von Hoff, MD, Physician-in-Chief and
Distinguished Professor at the Translational Genomics Research Institute in
Scottsdale, AZ and Consultant to Celgene made the presentation at the Symposium
where we learned what this study showed:
- Median survival time for patients treated with a
combination of Abraxane plus gemcitabine was 8.5 months vs. 6.7 months for
gemcitabine alone – an increase of 1.8 months or almost a 30% increase.
- One-year survival rate obtained with the Abraxane
plus gemcitabine combination showed an increase of 59% over the results seen
with gemcitabine alone.
The hope now is that Celgene will receive commercialization
approval for the new treatment. In an
interview with THE ASCO POST, a newspaper style publication collaborating with
the American Society of Clinical Oncology (ASCO, an international organization),
Dr. Von Hoff said:
“The past few decades have brought us very few treatment
advances for patients with advanced pancreatic cancer. I have counted 33 phase III trials since
1990, and only 3 were positive. This has
been a frustrating area.”
With that being said, enter Nuvilex, Inc. (OTCQB: NVLX) our
David in this story. Nuvilex could very well
be on the doorstep of having the next positive phase III trial since 1990. Through two independent mid-phase trials,
this international biotechnology company is producing even more dramatic
results than those found in the Celgene trials and doing it with a completely
This difficult to diagnose cancer, could be on the ropes
with these two companies showing incredible promise. As Nuvilex prepares to enter a large-scale,
late-stage trial with the combination of its living cell encapsulation technology
and the widely used anticancer drug, ifosfamide, for the first time since Eli
Lilly introduced gemcitabine (Gemzar®) back in 1996; two companies now have
real science producing even better results than the current standard.
Approach with Big Pharma Results
Nuvilex uses a unique and proprietary technology – Living Cell
The process forms a “platform” upon which treatments for
many serious, debilitating, and even fatal diseases may be built. Some of these diseases include different
types of cancer, diabetes, diseases for which stem cell therapies are being
developed, and diseases caused by viruses.
While it does sound confusing, in laymen’s terms, the
process uses living cells, and the company takes a very specific type of cell
to address a specific problem a patient suffers from. Scientists then wrap up cells in a type of
cellulose, forming essentially “cotton” capsules with live cells inside that
form this “platform” or bundled miniature “house” of cells about the size of
the head of a pin. At that point, each
bundled platform becomes much like a miniature cell factory with the ability to
produce whatever is needed.
Nuvilex has participated in two independent Phase II
clinical studies in patients with advanced, non-surgically-removable
(inoperable), pancreatic cancer,
using the encapsulated cells
capable of converting the widely-used anti-cancer
drug, ifosfamide, into its “cancer-killing” form.
The latest results using a broader set of data confirmed the
results found in the first Phase I/II trial.
Both trials offer sets of data that were done at different times, with
different populations, and in different hospitals. In the first trial, one location was used;
however the second Phase II trial expanded its database by using 4 different
Twenty-seven (27) patients were included in the trials and a
substantial response was seen in that the use of the living cell
encapsulation-ifosfamide combination helped patients to a better outcome than
that previoiusly reported with standard single-drug (Gemzar)therapy. Results
from these trials included:
Survival Time and One-Year Survival Rate were almost doubled as compared to
historical data for Gemzar.
severity of ifosfamide's side effects was reduced because only one-third of its
usual dose was used.
damage to tissues surrounding capsules was seen.
within the capsules were protected from attack by the patients’ immune systems.
inside the capsules were alive and functioning – even after more than two
Another notable difference in the two company’s results is
found in the side effects that patients have seen. While there were no serious side effects
found in Nuvilex’s study, the same can’t be said of the Celgene results as
there were 40% more patients experiencing neutropenia (38% vs. 27%) and far
more patients demonstrating neuropathy (17% to 1%) amongst other adverse
effects with the combination therapy when compared to Gemzar alone. In fairness, the neuropathy was reversible
with 44 percent of patients returning to treatment.
be Time for Eli Lilly to Share the Space
In 2008, sales of Gemzar exceeded $1.7-billion, and the drug
accounts for well over 55% of the sales of all drugs for advanced pancreatic
This is significant to both companies and certainly added
motivation to Nuvilex as it currently prepares for its large scale Phase III
pancreatic cancer trial.
In the future Phase III trial, Nuvilex’s pancreatic cancer
treatment will be compared “head to head” with Gemzar. Whereas only two cycles of ifosfamide were
used in the Phase II trials, for the Phase III trial, more than two cycles will
be given, as is often the case when ifosfamide is used in cancer
If the results obtained with Nuvilex’s treatment are
statistically better than those obtained with Gemzar, the company’s
treatment could replace Gemzar as the “gold standard” for the treatment of this
Last week Nuvilex’s subsidiary Austrianova Singapore,
reported the successful establishment of a research "cell bank" that
will ultimately be used to obtain the numbers of cells necessary for conducting
the company's late-phase clinical trials.
The American Cancer Society says that 80 percent of all
people diagnosed with pancreatic cancer will die within 1 year. On a 5-year basis, 96 out of every 100
patients will be dead, leaving the disease, in the words of the Hirshberg
Foundation for Pancreatic Cancer Research, as “incurable.”
If Nuvilex’s larger phase III trials confirm the data from
mid-stage trials, the company will likely no longer be a small biotech, but one
thing is for sure and that is patients have room for greater optimism now more
than ever with Celgene and Nuvilex fighting on their behalf to battle an even
great Goliath – pancreatic cancer.
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