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New Clinical Data Supports Development Of Bertilimumab In Both Ulcerative Colitis And Crohn's Disease

Wednesday, October 22, 2014 Drug News
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Immune Pharmaceuticals Recently Initiated Phase II Clinical Trial in Ulcerative Colitis

CAMBRIDGE, Mass. and HERZLIYA PITUACH, Israel, Oct. 22, 2014 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP; "Immune" or "the Company") announces that Dr. Tomer Adar, a gastro-enterologist at the Institute for Digestive Diseases at Shaare Zedek Medical Center, Israel, is presenting today at the United European Gastro-Enterology week in Vienna, Austria an abstract entitled "The importance of intestinal eotaxin-1 - Eosinophil axis in inflammatory bowel disease, Results of a prospective observational study." The study was supported in part by an unrestricted grant from Immune.
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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, commented: "This prospective clinical observational study demonstrates the pivotal role of eotaxin-1 in both Ulcerative Colitis and Crohn's Disease. Ongoing and future clinical trials will assess the relevance of selecting patients based on high eotaxin-1 tissue levels to optimize treatment response with anti-eotaxin 1 drugs such as Bertilimumab."
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According to the abstract presented by Professor Goldin's group, this observational clinical study demonstrates elevated tissue Eotaxin-1 levels in both Ulcerative Colitis and Crohn's Disease, especially in more severe, active disease. The increase in tissue but not in serum eotaxin-1 levels suggests its importance as a local mediator of mucosal inflammation. The correlation between tissue eotaxin-1 and tissue eosinophilia in active disease, marks its central role in mediating local inflammation. and also suggests that its role in the pathogenesis of Crohn's Disease is not restricted to eosinophil recruitment.

A previous study, supported in part by a National Institute of Health grant and published on December, 18, 2013 in PlosOne by Professor Keith Wilson at Vanderbilt University Medical Center, highlighted eotaxin-1 as an etiologic factor and therapeutic target in Ulcerative Colitis.

Coburn LA, Horst SN, Chaturvedi R, Brown CT, Allaman MM, et al. (2013) High-Throughput Multi-Analyte Luminex Profiling Implicates Eotaxin-1 in Ulcerative Colitis. PLoS ONE 8(12): e82300. doi:10.1371/journal.pone.0082300

About Ulcerative Colitis

Ulcerative colitis is a chronic, inflammatory immune-related 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. Ulcerative colitis can be debilitating and sometimes can lead to life-threatening complications. 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. Major surgery is often involved, and can cure the disease.

About Crohn's Disease

Crohn's disease is an immune-related, chronic inflammatory condition (auto-immune) that can involve any part of the gastrointestinal tract, but most frequently affects the end of the small bowel and the beginning of the large bowel. In Crohn's disease, all layers of the intestine may be involved and there can be normal healthy bowel between patches of diseased bowel. Symptoms include persistent diarrhea, abdominal pain, fever, and occasionally, rectal bleeding. Fatigue, loss of appetite and weight loss also may occur. There is no cure for the disease.

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 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 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.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-clinical-data-supports-development-of-bertilimumab-in-both-ulcerative-colitis-and-crohns-disease-405025186.html

SOURCE Immune Pharmaceuticals Inc.

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