Nuvilex, Inc. Could Obtain FDA Accelerated Approval After Phase 2b Clinical Trial
April 17 2014 - 8:45AM
Marketwired
Nuvilex, Inc. Could Obtain FDA Accelerated Approval After Phase 2b
Clinical Trial
NEW YORK, NY--(Marketwired - Apr 17, 2014) - Nuvilex, Inc.
(OTCQB: NVLX) has once again delivered a major announcement as it
advances its pancreatic cancer treatment toward late phase clinical
trials. Nuvilex continues to put forth what is turning into a
well thought out game plan for the future of treating advanced
pancreatic cancer. It's a game plan that could include
obtaining accelerated FDA approval of its pancreatic cancer
treatment if it can produce the same strong results in an announced
Phase 2b clinical trial that were produced in two separate Phase
1/2 trials using the combination of the Cell-in-a-Box® technology
with the anticancer drug ifosfamide.
The market may want to start connecting the dots with this
international biotech because as Nuvilex releases each piece of its
story, the path is leading to more and more impressive hands
guiding Cell-in-a-Box® and Nuvilex right to the FDA's door. In
fact, given pancreatic cancer is so deadly, it could be sooner
rather than later that the medical community becomes familiar with
the company in one form or another.
Nuvilex just named Clinical Network Services Pty Ltd (CNS) as
its Contract Research Organization (CRO) for late phase
trials. Yes, this is the same CNS that successfully took the
Cell-in-a-Box® technology combined with ifosfamide through Phase 1
& 2 clinical trials. Well, now the two entities will join
forces on a Phase 2b trial or what some call a "miniature Phase 3
trial." This two-arm study will see Nuvilex's treatment going
head to head with Celgene's treatment of Abraxane® plus
gemcitabine.
What investors may not realize is that through the FDA's
Accelerated Approval Program, Nuvilex could receive FDA approval of
its pancreatic cancer treatment using Phase 2b data. If CNS
can once again lead the combination of Cell-in-a-Box® with
ifosfamide to the same powerful results it generated in prior
trials that still today outperform Eli Lilly's Gemzar® and
Celgene's treatment, the FDA could grant accelerated approval for
the treatment. This program is one of several tools used by
the FDA to expedite the approval of medicines intended to treat
serious or unmet needs.
- Two months ago in February 2014, Chelsea Therapeutics
International announced that the FDA granted accelerated approval
of NORTHERA™ (droxidopa) for the treatment of symptomatic
neurogenic orthostatic hypotension (NOH).
- Three months ago in January 2014, the FDA approved
GlaxoSmithKline's Mekinist (trametinib) under the accelerated
approval program for use in combination with Tafinlar (dabrafenib)
as a possible treatment for patients suffering from inoperable
melanoma and certain types of metastatic melanoma.
- Five months ago in November 2013, the FDA granted accelerated
approval to Pharmacyclics, Inc.'s Ibrutinib (IMBRUVICA) for the
treatment of patients with mantle cell lymphoma (MCL) who have
received at least one prior therapy.
The FDA's Accelerated Approval Program allows for the approval
of an investigational drug or treatment based on a surrogate
endpoint (a measurement that can "stand in" for an accepted
measurement of disease progression) in early-phase studies if the
condition is serious or life-threatening, and Nuvilex should have
an excellent case for just such an approval.
If that were to happen, the company may or may not be required
to conduct a Phase 3 trial while its treatment is being used by
patients with advanced, inoperable pancreatic cancer. It
would, however, undergo a Phase 4 or "confirmatory study" to
further evaluate and confirm the efficacy and safety of the
treatment, but it would do so with Cell-in-a-Box® combined with
ifosfamide on the market.
About Stock Market Media Group
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Interviews and Articles. SMMG is compensated for Nuvilex articles,
reports and interviews by a third party who reserves the right to
buy, sell or remain neutral on securities at any time before,
during, or after the publication of this article. To date, SMMG has
received total compensation of $74,115 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 its content
work. 100,000 of those shares have been held for the requisite
period under Rule 144 as of October 31, 2013, and are eligible to
be sold immediately. To date, none of the Rule 144 eligible shares
have been sold; however, the principal reserves the right to sell
all or part of those shares in Nuvilex at any time without further
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