NEW YORK, Oct. 27, 2016 /PRNewswire/ -- Immune
Pharmaceuticals (NASDAQ:IMNP) (Immune) announced today that it has
received guidance from the United States Food and Drug
Administration (FDA) on a phase III study for Ceplene in
combination with low dose IL-2 for the maintenance of remission in
patients with Acute Myeloid Leukemia (AML). Ceplene/IL-2 has
previously been approved in Europe
and Israel following a successful
phase III study with Leukemia Free Survival as the primary
endpoint. The proposed phase III study design reviewed by the FDA
focuses on overall survival as the primary endpoint, along with key
secondary endpoints, including Leukemia Free Survival.
The FDA also provided feedback relating to specific design
elements of the phase III study, and with this framework, Immune
plans to submit the final protocol for the phase III study in early
2017 and, upon approval, proceed with conducting a global Phase III
Pivotal Overall Survival Study in AML maintenance of response with
Ceplene/IL2.
"We are very pleased with the positive outcome of our recent
interaction with the FDA. Our path forward to proceed with a
pivotal study following regulatory guidance of Ceplene/IL-2 meets
our goal to address the urgent unmet medical need for remission
maintenance therapy in AML," stated Monica
Luchi, MD, Immune's Chief Medical Officer.
About Immune Pharmaceuticals Inc.:
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized
approach to treating and developing novel, highly targeted antibody
therapeutics to improve the lives of patients with inflammatory
diseases and cancer. Immune's lead product candidate, bertilimumab,
is in Phase II clinical development for moderate-to-severe
ulcerative colitis as well as for bullous pemphigoid, an orphan
autoimmune dermatological condition. Other indications being
considered for development include atopic dermatitis, Crohn's
disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH),
an inflammatory liver disease. Immune recently expanded its
portfolio in immuno-dermatology with topical nano-formulated
cyclosporine-A for the treatment of psoriasis and atopic
dermatitis. Immune's oncology pipeline includes Ceplene® which is
in late stage clinical development for maintenance remission in
Acute Myeloid Leukemia (AML) in combination with IL-2. Additional
oncology pipeline includes Azixa® and crolibulin, Phase II clinical
stage vascular disrupting agents, and novel technology platforms;
bispecific antibodies and NanomAbs™. Maxim Pharmaceuticals Inc.,
Immune's pain and neurology subsidiary is developing AmiKet™ and
AmiKet™ Nano™ for the treatment of neuropathic pain. For more
information, visit Immune's website at www.immunepharma.com, the
content of which is not a part of this press release.
Forward-Looking Statements
This news release and any oral statements made with respect to the
information contained in this news release contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. You are urged to consider statements that
include the words "may," "will," "would," "could," "should,"
"believes," "estimates," "projects," "potential," "expects,"
"plans," "anticipates," "intends," "continues," "forecast,"
"designed," "goal" or the negative of those words or other
comparable words to be uncertain and forward-looking. Such
forward-looking statements include statements that express plans,
anticipation, intent, contingency, goals, targets, future
development and are otherwise not statements of historical fact.
These statements are based on our current expectations and are
subject to risks and uncertainties that could cause actual results
or developments to be materially different from historical results
or from any future results expressed or implied by such
forward-looking statements. Factors that may cause actual results
or developments to differ materially include, but not limited to:
the risks associated with the adequacy of our existing cash
resources and our ability to continue as a going concern; the risks
associated with our ability to continue to meet our obligations
under our existing debt agreements; the risk that clinical trials
for bertilimumab, Ceplene, Azixa, AmiKet, AmiKet Nano, LidoPain or
NanoCyclo will not be successful; the risk that bertilimumab,
AmiKet or compounds arising from our NanomAbs program will not
receive regulatory approval or achieve significant commercial
success; the risk that we will not be able to find a partner to
help conduct the Phase III trials for AmiKet on attractive terms,
on a timely basis or at all; the risk that our other product
candidates that appeared promising in early research and clinical
trials do not demonstrate safety and/or efficacy in larger-scale or
later-stage clinical trials; the risk that we will not obtain
approval to market any of our product candidates; the risks
associated with dependence upon key personnel; the risks associated
with reliance on collaborative partners and others for further
clinical trials, development, manufacturing and commercialization
of our product candidates; the cost, delays and uncertainties
associated with our scientific research, product development,
clinical trials and regulatory approval process; our history of
operating losses since our inception; the highly competitive nature
of our business; risks associated with litigation; and risks
associated with our ability to protect our intellectual property;
risks associated with the contemplated transaction with NPT. These
factors and other material risks are more fully discussed in our
periodic reports, including our reports on Forms 8-K, 10-Q and 10-K
and other filings with the U.S. Securities and Exchange Commission.
You are urged to carefully review and consider the disclosures
found in our filings, which are available at www.sec.gov or at
www.immunepharma.com. You are cautioned not to place undue reliance
on any forward-looking statements, any of which could turn out to
be wrong due to inaccurate assumptions, unknown risks or
uncertainties or other risk factors. We expressly disclaim any
obligation to publicly update any forward-looking statements
contained herein, whether as a result of new information, future
events or otherwise, except as required by law.
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SOURCE Immune Pharmaceuticals Inc.