CAMBRIDGE, Mass. and HERZLIYA PITUACH, Israel,
Sept. 18, 2014 /PRNewswire/ -- Immune Pharmaceuticals
Inc. (NASDAQ: IMNP; "Immune" or "the Company") announces today that
it has initiated the screening of patients for a Phase II proof of
concept clinical trial exploring the safety and efficacy of
bertilimumab in the treatment of ulcerative colitis (UC).
Dr. Daniel Teper, Chairman and CEO of Immune
comments: "Bertilimumab is among the first biologic drugs for
auto-immune diseases with a biomarker strategy. We look
forward to the results of this Phase II proof of concept clinical
trial in Ulcerative Colitis as well as the previously initiated
Phase II clinical trial in Bullous Pemphigoid, an orphan
auto-immune disease of the skin."
Professor Eran Goldin, Chairman
of the Institute for Digestive Diseases at Shaare Zedek Medical
Center, part of the Hebrew University
School of Medicine in Jerusalem,
Israel, is the Principal Investigator of the trial, which
will include over 10 clinical sites.
The Bertilimumab Phase II clinical trial is a randomized, double
blind, placebo-controlled, parallel group multi-center study in
adult patients with active moderate to severe UC. Eligible patients
will be randomly assigned in a 2:1 ratio to one of two treatment
groups, bertilimumab 10 mg/kg or matching placebo, respectively.
The study will consist of three periods: a screening period of up
to two weeks, a four-week double-blind treatment period (three IV
infusions over 30 minutes, at two-week intervals), and a safety and
efficacy follow-up period of approximately nine weeks. Patient
selection is based on elevated tissue eotaxin-1, a biomarker that
has been shown to be associated with severity of disease in Bullous
Pemphigoid, Ulcerative Colitis, Crohn's Disease, Severe Asthma and
other conditions. Bertilimumab is a recombinant human IgG4
monoclonal antibody that neutralizes human eotaxin-1 (eotaxin).
About Ulcerative Colitis
Ulcerative colitis is a chronic, inflammatory
auto-immune disorder limited to the large bowel (colon and rectum)
and only affects the inner lining of the colon. The main symptom is
diarrhea that is generally bloody and may be associated with
abdominal pain. Loss of appetite and subsequent weight loss are
common, as is fatigue. Severe bleeding may result in anemia. The
symptoms of ulcerative colitis tend to come and go, with fairly
long periods in between flare-ups in which patients may experience
no distress at all.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. applies a personalized approach to
treatment, developing novel, highly targeted antibody therapeutics
to improve the lives of patients with inflammatory diseases and
cancer. The Company's lead product candidate, bertilimumab,
is in clinical development for moderate to severe Ulcerative
Colitis and Crohn's Disease as well as Bullous Pemphigoid, an
orphan auto-immune dermatological condition. Immune licensed
worldwide rights for systemic indications of bertilimumab from iCo
Therapeutics (TSX: ICO; OTCQX: ICOTF) in June 2011, while iCo retained rights to all
ophthalmic indications. iCo originally licensed the exclusive
world-wide rights to bertilimumab in 2006 from MedImmune, the
Global Research and Development Arm of AstraZeneca. Immune's
pipeline also includes NanomAbs®, antibody nanoparticle conjugates,
for the targeted delivery of chemotherapeutics, and Amiket™, a
Neuropathic Pain drug candidate ready for Phase III. Amiket has
received Fast Track designation for chemotherapy induced
neuropathic pain and Orphan Drug Designation for Post Herpetic
Neuralgia.
For more information, visit Immune's website at
www.immunepharmaceuticals.com, the content of which is not a part
of this press release.
Erik Penser Bankaktiebolag is engaged as Immune's Certified
Adviser on NASDAQ OMX First North Premier.
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: 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 or AmiKet™ will not be successful; the risk that
bertilimumab, AmiKet™ or compounds arising from our NanomAb®
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, 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. 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.immunepharmaceuticals.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.
SOURCE Immune Pharmaceuticals Inc.