NEW YORK, June 25, 2015 /PRNewswire/ -- Immune
Pharmaceuticals Inc. (NASDAQ: IMNP) announced today that it has
initiated its Phase II Ulcerative Colitis clinical trial and is
scheduled to initiate its Phase II Bullous Pemphigoid clinical
trial on July 1, 2015. Study
Initiation is the training of hospital staff to allow for patient
screening and immediate patient enrollment into the clinical trial
upon selection.
Paul I. Nadler, MD, FCP, FACP
Executive Vice President, R&D and Chief Medical Officer of
Immune Pharmaceuticals, commented, "We believe that bertilimumab is
a promising first in class monoclonal antibody with the potential
to treat multiple inflammatory diseases. It targets eotaxin-1,
which is also a biomarker of disease severity, supporting a
personalized medicine and companion diagnostic strategy. The first
two Phase II clinical trials with bertilimumab in Bullous
Pemphigoid and Ulcerative Colitis are expected to provide guidance
on further clinical development."
The bertilimumab Phase II Bullous Pemphigoid clinical trial is
designed as an open label clinical trial in 10 patients, with
moderate to severe Bullous Pemphigoid. Bullous Pemphigoid is an
orphan chronic skin blistering disease affecting around 60,000
people globally, mostly in the elderly population, according to a
Chardan Capital report. Primary end points include safety and
efficacy, measured by a reduction in clinical symptoms and tapering
down of systemic corticosteroids. Initial data is expected in
late 2015 or early 2016.
The bertilimumab Phase II Ulcerative Colitis clinical trial is
designed as a double blind placebo controlled trial in 42 patients,
with moderate to severe disease. Ulcerative Colitis is a
chronic inflammatory bowel disease (IBD) that causes long-lasting
inflammation and ulcers in the digestive tract and affects
around 2 million people worldwide according to a Global Data
Report. Primary end points are safety and efficacy, measured by a
reduction in the Mayo Clinic Ulcerative Colitis Disease Index at 8
weeks. Secondary end points include assessment of mucosal
injury and clinical remission. Patients are selected based on
Mayo score and high levels of tissue eotaxin-1 as well as other
standardized clinical criteria. The completion of the clinical is
expected by the end of 2016.
A Vanderbilt study, sponsored by the
National Institute of Health, and published in PlosOne (PLoS
One. 2013 Dec 18;8(12)) showed a statistically
significant correlation between tissue eotaxin-1 levels and
severity of the disease as well as disease
activity in ulcerative colitis patients. The authors
concluded that their data implicates eotaxin-1 as an etiologic
factor and therapeutic target in UC, and that eotaxin-1 measurement
may be useful to select patients for therapy with bertilimumab.
The first Immune Pharmaceuticals R&D day will take place on
September 8, 2015 at the Alexandria
Center for Life Science in New York
City.
Immune management and several Key Opinion Leaders will outline
Immune's R&D strategy and development plans, including the
following:
- Bertilimumab 2016 clinical development plan expansion with a
second double blind placebo controlled bullous pemphigoid clinical
trial and pilot clinical trial in liver diseases (NASH) and severe
asthma;
- Development plan for topical nano-formulated cyclosporine A in
psoriasis and atopic dermatitis; and
- Development for NanomAbs in oncology.
About Immune Pharmaceuticals
Immune Pharmaceuticals
Inc. applies a personalized approach to treating and, 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 also signed a binding Memorandum of
Understanding with Yissum, the Technology Transfer Company of
the Hebrew University of Jerusalem,
regarding the worldwide exclusive licensing and development of a
topical nano-formulated cyclosporin A for the
treatment of psoriasis and atopic dermatitis. 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 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.
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SOURCE Immune Pharmaceuticals Inc.