Nuvilex Eyes FDA Accelerated Approval Process by Improving Quality of Life in Pancreatic Cancer Patients
May 23 2014 - 9:00AM
Marketwired
Nuvilex Eyes FDA Accelerated Approval Process by Improving Quality
of Life in Pancreatic Cancer Patients
NEW YORK, NY--(Marketwired - May 23, 2014) - Nuvilex (OTCQB:
NVLX) is calling it a "two pronged attack" on pancreatic cancer,
but investors may be calling it an "end-around" or another avenue
of sorts, a quicker avenue to FDA approval. This week Nuvilex
peeled back another layer of its work with pancreatic cancer, and
this time it was to tell the market that the well-respected
Translational Drug Development (TD2) will be studying the company's
pancreatic cancer treatment, the combination of
Cell-in-a-Box®/ifosfamide, for the deadly disease. TD2 will
study an area of great interest to the Food and Drug Administration
(FDA), and an area that may be key to the FDA granting accelerated
approval -- "quality of life."
Nuvilex and TD2 have begun preparing for US-based preclinical
and then clinical studies on the unbearable pain and the
accumulation of fluid, referred to as ascites, in the abdominal
cavity. These are two commonly occurring symptoms associated
with advanced pancreatic cancer as well as other abdominal
cancers.
In two earlier Phase I/II clinical trials, Nuvilex's pancreatic
cancer treatment was shown to reduce the size of tumors in a
significant portion of those patients being treated, and thereby
reduced their pain, improved their quality of life, and did so with
no negative side-effects. Nuvilex and TD2 may very well be on
the path to proving that the combination of
Cell-in-a-Box/ifosfamide can benefit those suffering from
pancreatic cancer and all other abdominal cancers where the growth
of tumors is causing intense pain and where ascites is
prevalent.
Nuvilex could be about to demonstrate a real breakthrough for
cancer patients and increase their willingness to live with an
improved "quality of life." This "quality of life" angle is a
much talked about topic inside the FDA, and is a basis for
accelerated approval if the studies performed by TD2 appear to
provide a "clinical benefit." Accelerated approval is based on
a surrogate endpoint that is reasonably likely to predict a
"clinical benefit," such as prolonged life or a better "quality of
life."
Although improvement in survival (being developed in Nuvilex's
Phase 2b) is the gold standard, a better "quality of life" is an
acceptable bases for regular approval of a drug or biological
product. Drug and biological product approvals that are based
on a better "quality of life" have generally included drugs or
biological products that prevent or ameliorate cancer-related
symptoms, including, those that prevent or relieve pain.
So, let's set the scene for investors. Preclinical studies
can be relatively quick to discern a potential "clinical benefit"
or to recognize an endpoint such as any amount of shrinkage in a
tumor that can lead to the relief of associated pain, and the
duration of time for the onset of ascites with and without the use
of Nuvilex's Cell-in-a-Box/ifosfamide combination. If TD2 is
successful, the company could then enter Phase 1 clinical trials in
humans and again, these trials could be relatively short, and if
they too are successful, Nuvilex could receive accelerated approval
using Phase 1 data. Yes, companies have been granted
accelerated approval based solely on Phase 1 data as the
designation is designed for drugs or biological products in early
phase trials.
TD2 and its world class Pancreatic Cancer Research Team (PCRT)
obviously saw the results from earlier Phase I/II trials and feel
Nuvilex's pancreatic cancer treatment can make a difference in the
"quality of life" for those suffering what will be the second
leading cancer killer in the US by 2030 according to a new report
published this week in the American Association for Cancer
Research's journal.
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. SMMG has received total compensation
of $87,580 for 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. The shares
have been held for the requisite period under Rule 144 as of
October 31, 2013 and April 30, 2014, and are eligible to be sold
immediately without further notice. For more information:
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