Immune Pharmaceuticals Initiates Phase II Clinical Trial In Ulcerative Colitis

Company Recently Initiated Phase II in Bullous Pemphigoid

Sep 18, 2014

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.

For further information: Immune Pharmaceuticals Inc.: Anna Baran, Director of Investor Relations, Tel: 646 937 1941, anna.baran@immunepharma.com; Immune Pharmaceuticals Ltd.: Sarit Steinberg, Tel: +972-9-8866612


print email rss