CAMBRIDGE, Mass. and HERZLIYA
PITUACH, Israel, July 30, 2014 /PRNewswire/ -- Immune
Pharmaceuticals Inc. (OTCQX and NASDAQ OMX First North Premier,
Stockholm: "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 moderate to severe bullous pemphigoid. This open-label trial
will enroll 10-15 patients who will receive two bertilimumab
infusions, at a dose of 10 mg/kg, on days 0 and 14. Patients will
also start concomitant treatment with an initial moderate dose of
oral prednisone (30 mg daily) to be tapered down rapidly starting
as early as week 1 based on patient response. Patients will be
followed for eight weeks with primary efficacy end points focused
on disease control measured by the Bullous Pemphigoid Disease Area
Index, a validated index developed by international experts in this
indication, and steroid sparing, the proportion of patients who
achieve a steroid dose of </= 10 mg daily at the end
of follow up. The study principal investigator is Eli Sprecher, M.D., Ph.D., Professor of
Dermatology, Sackler Faculty of Medicine, Tel
Aviv University, and Chairman of the Department of
Dermatology at the Sourasky Medical Center in Tel Aviv, Israel.
Dr. Daniel Teper, Chairman and
CEO of Immune comments: "Following the announcement last week of
our partnership with Lyfebulb, and future
collaborative activities with the International Pemphigus and
Pemphigoid Foundation (IPPF), we are pleased to announce the
commencement of patient screening in a Phase II bullous pemphigoid
clinical trial with bertilimumab. We will continue to work closely
with key opinion leaders, patient advocacy organizations and
regulatory authorities to design a clinical development program
that we believe will help bring needed new options for patients
with bullous pemphigoid."
About Bullous Pemphigoid
Bullous pemphigoid (BP) is a rare, potentially life threatening
autoimmune disease where painful blisters develop on the skin,
eyes, mouth, and throat. Each year, BP affects over 30,000 patients
in the United States and
Europe. Typically, patients are
over 65 years old and their immediate support system may include
their adult children. The disease is treated by a small group of
specialists in dermatology and oral medicine.
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 Astra-Zeneca.
Immune's pipeline also includes NanomAbs®, a portfolio of antibody
nanoparticle conjugates, for the targeted delivery of
chemotherapeutics, crolibulin, a small molecule in Phase II for
(indication) in collaboration with the National Cancer Institute
and Amiket™, a Phase III-ready neuropathic pain candidate. Amiket
has received Orphan Drug Designation for Post-Herpetic Neuralgia in
the US.
For more information, please 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.
About Lyfebulb
Lyfebulb was founded in 2014 by Karin
Hehenberger M.D., Ph.D., with a mission of helping those
living with a chronic disease lead an optimal lifestyle. Through an
online platform and offline events, Lyfebulb connects, educates,
and inspires individuals living with chronic illnesses. The
Lyfebulb Social Club is a monthly series of meetings bringing
together thought leaders, patients, experts and renowned
professionals in an informative and relaxed environment.
For more information, please visit www.lyfebulb.com.
About International Pemphigus & Pemphigoid
Foundation
The International Pemphigus & Pemphigoid Foundation (IPPF)
provides support, advocacy, awareness, and education to those
affected by the rare, autoimmune blistering diseases (AIBD)
pemphigus and pemphigoid. Since 1994, the IPPF has helped thousands
of patients, caregivers, and medical professionals by reducing
diagnostic delays in increasing P/P awareness and knowledge. For
more information on the IPPF, call (855) 4-PEMPHIGUS, (916)
922-1298, or visit us online at www.pemphigus.org
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 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
we will not obtain approval to market and commercialize 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; risks associated with our ability to
protect our intellectual property; risks associate with our ability
to raise additional funds; and our liquidity. 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. 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.
SOURCE Immune Pharmaceuticals Inc.