Immune Pharmaceuticals Initiates Phase II Clinical Trials With Bertilimumab In Ulcerative Colitis And Bullous Pemphigoid

2016 CLINICAL DEVELOPMENT PLANS TO BE PRESENTED AT IMMUNE R&D DAY ON SEPTEMBER 8, 2015

Jun 25, 2015

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.

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 or AmiKet 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. 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.

For further information: Anna Baran, Director, Corporate Affairs, Tel: 646-561-8010, anna.baran@immunepharma.com


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