Phase II Trial to Focus on Moderate to Severe UC Patients with Eotaxin-1 Biomarker
TARRYTOWN, N.Y. and HERZLIYA-PITUACH, Israel, Oct. 16, 2013 /PRNewswire/ -- Immune Pharmaceuticals Inc. (OTCQX and NASDAQ OMX Stockholm Exchange: IMNP) announced today that Tomer Adar, M.D. at the Digestive Diseases Institute, Shaare Zedek Medical Center, Hebrew University of Jerusalem, presented a poster on October 15, 2013 entitled Inhibition of Eotaxin-1 (CCL 11) Ameliorates DSS-Induced Colitis; A Novel Potential Therapeutic Approach for Inflammatory Bowel Disease, at the United European Gastroenterology Week being held in Berlin, Germany.
This study was performed to evaluate the effect of eotaxin-1 (CCL-11) inhibition on BALB/c mice with dextran sodium sulfate (DSS)-induced colitis. The mice were treated with an anti-eotaxin-1 monoclonal antibody or a control antibody. Inhibition of eotaxin-1 resulted in significant amelioration of DSS-induced colitis demonstrated by statistically significant reduction in both disease activity index and body weight loss compared to controls. These results indicate the importance of eotaxin-1 in regulating intestinal mucosal inflammation, and its potential as a future therapeutic target in inflammatory bowel disease (IBD).
Bertilimumab is a fully human monoclonal antibody with high specificity for human eotaxin-1. Bertilimumab was originally developed by Cambridge Antibody Technologies, now part of MedImmune, the Global Research and Development Arm of AstraZeneca. Immune has initiated a double blind placebo controlled Phase II international study, which compares bertilimumab with placebo in 105 patients with moderate to severe ulcerative colitis. Patients are selected based on elevated eotaxin-1 levels from colonic biopsy samples. Topline data from this trial is expected in early 2015.
Eran Goldin, M.D., Chairman of the Digestive Diseases Institute at Shaare Zedek Medical Center in Jerusalem, commented: "Eotaxin-1 is a biomarker of IBD and a potential target for therapeutic intervention. This new selective approach is promising for patients with moderate to severe ulcerative colitis. We look forward to the Phase II clinical data with bertilimumab."
Marc Rothenberg, M.D.,Ph.D., Director of the Division of Allergy and Immunology at Cincinnati Children's Hospital Medical Center, one of the pioneer researchers on eotaxin, commented: "Eotaxin-1 is a key regulator of gastrointestinal eosinophils, and its neutralization by bertilimumab is an attractive approach to potentially treating IBD. Bertilimumab targets the innate (not adaptive) immune system by blocking an inflammatory ligand, similar to the action of anti-TNF therapies. The study by Professor Eran Goldin's group adds further data substantiating a contributory role of eotaxin-1 and eosinophils in key processes involved in IBD."
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (OTCQX and NASDAQ OMX Stockholm Exchange: IMNP) 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 entering Phase II clinical studies for moderate to severe ulcerative colitis and bullous pemphigoid, with additional studies planned for Crohn's disease and severe asthma. The Company is evaluating the use of its NanomAb® platform, a second generation antibody drug conjugate technology, with chemotherapeutics in order to enhance their safety and efficacy profiles by delivering the medicines directly to cancer cells. The Company's growing oncology pipeline also includes proprietary antibodies and, clinical-stage small molecules that have been shown activity in a variety of solid tumors.
Immune licensed worldwide rights for systemic indications of bertilimumab from iCo Therapeutics (TSX: ICO) 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 is headquartered in Tarrytown, New York, with its primary research and development facilities in Herzliya-Pituach, Israel.
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: 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, crolibulin or AmiKet™ will not be successful; the risk that bertilimumab, crolibulin, 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.
CONTACT: Immune Pharmaceuticals Inc.: Anna Baran, Director of Investor Relations and Corporate Communications, Tel: (914) 606-3500 or (646) 937-1941, anna.baran@immunepharma.com
