Nuvilex's Pancreatic Cancer Treatment Readies to Challenge Eli Lilly and
Celgene in Late-Phase Clinical Trials
NEW YORK, NY -- (Marketwired) -- 02/19/14 -- Nuvilex, Inc. (OTCQB:
NVLX) is a small biotech firm in Silver Spring, Maryland, that hopes
to soon be mentioned with much larger biotechnology and
pharmaceutical companies like Eli Lilly and Celgene. If the company's
pancreatic cancer treatment that combines the proprietary
cellulose-based live-cell encapsulation technology known as
Cell-in-a-Box(TM) with the anti-cancer drug ifosfamide can produce
the same or better data in its upcoming late-phase clinical trials in
advanced, inoperable pancreatic cancer than were seen with this same
combination in two earlier independent Phase II trials, then not only
will it be mentioned with those larger companies, Nuvilex's treatment
will likely be the new "gold standard" for the disease.
So far, Nuvilex has methodically gone about its business laying the
groundwork for its future trials. It's a process that demands a
meticulous approach, especially when the outcome could lead to
billions of dollars. Eli Lilly has realized more than $10 billion
with its cancer drug Gemzar(R) (gemcitabine) since it was approved in
1996 as the gold standard for advanced, inoperable pancreatic cancer.
It wasn't really until Celgene's drug Abraxane (a nanoparticle
formulation of the widely used drug Taxol with albumin) in
combination with gemcitabine was approved in 2013 that patients had a
better option than single-agent gemcitabine.
Approval of Celgene's treatment was undoubtedly assisted by the
involvement of Dr. Daniel D. Von Hoff, who was also the principal
investigator for the first clinical trial of gemcitabine and is
considered among the nation's leading authorities on pancreatic
cancer. In his role as Consultant to Celgene, Dr. Von Hoff helped to
get approval for Celgene's Abraxane-gemcitabine combination
fast-tracked by showing the FDA that there is an urgent need for
better treatments for advanced pancreatic cancer.
Now it is Nuvilex's turn. The company's advanced pancreatic cancer
treatment that combines the Cell-in-a-Box technology with ifosfamide
has provided better results than both gemcitabine alone and the
Abraxane-gemcitabine combination. Those results included an increase
of about 4 months in median survival time over gemcitabine alone
versus the 1.8 months seen with the Abraxane-gemcitabine combination.
The results also included a 100% increase in the one-year survival
rate as compared to gemcitabine versus a 59% increase for the
Abraxane-gemcitabine combination. The results obtained with Nuvilex's
treatment are even more noteworthy given that only one-third of the
dose of ifosfamide normally used to treat other types of cancer was
used in the Phase II pancreatic cancer trials.
Another apparent advantage for Nuvilex's treatment compared to the
Abraxane-gemcitabine combination concerns the side effects
(toxicities) associated with both treatments. Significant and severe
drug-associated toxicities were seen with the Abraxane-gemcitabine
combination, whereas with Nuvilex's treatment, side effects were
essentially non-existent. The lack of side effects from the
Cell-in-a-Box-ifosfamide combination is undoubtedly related to the
low dose of ifosfamide used.
For Nuvilex's investors, the good news is that, once funding is
secured for the late- phase clinical trials, companies like Celgene
are likely to take notice. After all, the global biopharmaceutical
was able to quickly get the Abraxane-gemcitabine combination approved
by showing both an urgent need for better pancreatic cancer
treatments and better results than those seen 17 years before with
the prior gold standard Gemzar. Well, nothing has changed - there is
still a need, and Nuvilex may just prove again its treatment
consisting of the combination of Cell-in-a-Box with ifosfamide can
produce even better results than Celgene's recently approved therapy.
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