New Data on Ceplene® Cancer Immunotherapy to be Presented at the 2016 AACR Annual Meeting

Overall Survival was Predicted by Re-Distribution of Cytotoxic T-Cell Subsets During Therapy with Ceplene in Patients with Acute Myeloid Leukemia

Mar 17, 2016

NEW YORK, March 17, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) announced today that new clinical pharmacology and outcomes data with Ceplene (histamine dihydrochloride) will be presented by Prof. Kristoffer Hellstrand, Dr. Anna Martner and their scientific colleagues from the University of Gothenburg, Sweden and Università di Roma, Italy, at the upcoming American Association of Cancer Research (AACR) annual conference to be held April 16-20 in New Orleans.

Results of a post-marketing clinical study using Ceplene in patients with acute myeloid leukemia (AML) will be presented at the conference. The study showed that immunotherapy with Ceplene and low-dose IL-2 led to a re-distribution of cytotoxic T-cell subsets in blood towards a tumor-killing phenotype. These immunological properties of Ceplene/IL-2 therapy significantly predicted clinical outcomes such as relapse and survival.  The results illustrate the potential for the use of T-cell biomarkers to accurately predict the efficacy of Ceplene/IL-2 in patients with AML, and to focus treatment on those patients most likely to benefit.

Abstract # CT 116: Dynamics of cytotoxic T cell subsets during immunotherapy predicts outcome in acute myeloid leukemia

Presenters: Anna Martner, Ph.D. and  Kristoffer Hellstrand, M.D., Ph.D
Poster session: Phase II, III, and Special Population Clinical Trials 
Session date and time: Tuesday Apr 19, 2016 1:00 PM - 5:00 PM
Location: Convention Center, Halls G-J, Poster Section 13, Poster Board #16

"Ceplene is a first-in-class histamine receptor agonist in cancer immunotherapy and there are no other drugs approved for remission maintenance in AML. These new data significantly expand our knowledge of the immunological activation pathway following Ceplene/IL-2 therapy in patients suffering from AML and will provide a personalized approach for getting the right treatment to the right patients" said Dr. Miri Ben-Ami, President, Immune Pharmaceuticals (Israel) and Immune's EVP, Global Oncology.

About Ceplene®

Ceplene® is a first-in-class immunotherapeutic, opening a new frontier in immune-oncology by exploiting the ability of histamine binding to the H2 receptor in modulating the immune response to cancer. Ceplene® protects the immune system against inactivation and apoptosis induction by leukemic cells enabling IL-2 stimulated T Cells and Natural Killer (NK) cells to eliminate residual leukemia cells and protect patients against relapse. Ceplene® administered in conjunction with low dose IL-2 immunotherapy is approved in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia, an orphan indication with poor survival prognosis and no effective therapy available to patients to prevent them from relapsing after achieving remission.

About Immune Pharmaceuticals:

Immune Pharmaceuticals (NASDAQ: IMNP) applies a personalized approach to treatment and development of novel, highly targeted therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's oncology pipeline includes bispecific antibodies, nanotherapeutics, including NanomAbs, and several mid-to-late stage small molecules including Ceplene®, Azixa® and Crolibulin®. Ceplene is approved in over 30 European countries and Israel.  Immune's lead product candidate for the treatment of inflammatory disease, bertilimumab, is in phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and NASH (an inflammatory liver disease). Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune's non-core pipeline includes AmiKet™, a late clinical stage drug candidate for the treatment of neuropathic pain. 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: For further information: Danielle Shapira, Manager, Strategic Planning, IMMUNE Pharmaceuticals, Inc., 646.440.9327, danielle.shapira@immunepharma.com


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