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New Biomarker Data To Be Presented at AACR Helps Predict Overall Survival in Patients with Acute Myeloid Leukemia (AML) Treated with Ceplene® and Low-dose IL-2 Immunotherapy, Including Those Over 60 Years of Age

Tuesday, April 19, 2016 Cancer News J E 4
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Previous Phase III Study Had Demonstrated Improvement of Over 130% in 3 Year Leukemia Free Survival in M4-M5 AML Subtype Patients Under 60 Years of Age

NEW YORK, April 19, 2016 /PRNewswire/ -- Scientists from Gothenburg University, Sweden will report data today at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA, on an immune mechanism-based biomarker to predict the potential efficacy of treatment with Ceplene® in the difficult-to-treat above 60 year old population with Acute Myeloid Leukemia (AML). Ceplene, in combination with low-dose Interleukin-2 (IL-2), is currently approved but not actively marketed in over 30 countries in Europe and Israel for the treatment of AML for maintenance of remission and prevention of disease relapse, an indication for which there are no other approved therapies.

Since the previous Ceplene/IL-2 phase III trial, which demonstrated an almost 50% improvement in 2 year leukemia free survival (LFS) in the overall population treated with Ceplene immunotherapy, a great deal has been learned about the biology of Ceplene® based immune-regulation. In AML, histamine H2 Receptors (H2R) are predominantly expressed on FAB subtypes with monocytic differentiation, namely M4 and M5.  In these subtypes, the binding of histamine to the H2R results in down-regulation of NOX2 with resultant decreased production of Reactive Oxygen Species (ROS) and subsequent protection of deleterious immune cells from deactivation and death.  When combined with low dose IL-2, Ceplene allows for the activation of the T and Natural Killer (NK) cells toward a tumor killing effect. 

In the Phase IV international study, which will be presented at the AACR Annual Meeting today, a reduction in the frequency of CD8+ T effector memory (TEM) cells during the first cycle of HDC/IL-2 prognosticated LFS (HR 0.25, P=0.001) and OS (HR 0.24, P=0.009). Similarly, induction of T effector cells (Teff) during cycle 1 impacted favorably on outcome (P=0.048 for OS). Patients with a concomitant reduction of TEM cells and induction of Teff cells during immunotherapy showed an even more favorable outcome in terms of LFS (HR 0.19, P=0.001) and OS (HR 0.13, P=0.008). Thus, the altered distribution of cytotoxic T cells during treatment with HDC/IL-2 significantly prognosticated LFS and OS especially within the group of elderly patients (above 60 years of age), providing a potential personalized approach for treating the more therapy-resistant older AML patient population, in addition to selection of the population most likely to benefit by FAB subtype.

Miri Ben-Ami, MD, President, Immune Oncology Pharmaceuticals Inc. stated, "We believe that the new data may allow a personalized approach to selection of patients who are most likely to benefit from Ceplene/IL-2 treatment in AML, in particular the older patient population who have demonstrated almost 100% survival when positive for the T-cell transition biomarkers." Dr. Ben-Ami continued, "In addition, current research is revealing the potential synergy between immune checkpoint inhibitors and Ceplene, which could open the possibility of additional therapeutic indications for this combination."

About Immune Pharmaceuticals Inc.:

Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, 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 oncology pipeline includes Ceplene/IL-2 approved in Europe and Israel for maintenance remission in AML, Azixa and crolibulin, Phase II-ready vascular disrupting agents, and novel technology platforms; bispecific antibodies and targeted nanotherapeutics, NanomAbs. Immune's additional pipeline includes AmiKet Nano™, 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 and 10-Q and our annual report on Form 10-K for the year ended December 31, 2015 and other filings with the U.S. 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.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-biomarker-data-to-be-presented-at-aacr-helps-predict-overall-survival-in-patients-with-acute-myeloid-leukemia-aml-treated-with-ceplene-and-low-dose-il-2-immunotherapy-including-those-over-60-years-of-age-300253646.html

SOURCE Immune Pharmaceuticals Inc.

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