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Immune Pharmaceuticals Files New Patent Application for Ceplene in Combination with Checkpoint Inhibitors
PR Newswire

NEW YORK, Feb. 10, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP), "Immune", a clinical-stage biopharmaceutical company, announced today that it has filed a patent application directed to the treatment of Acute Myeloid Leukemia and other cancers.

The new invention provides methods of treating cancer by administration of Ceplene (histamine dihydrochloride) in combination with immune checkpoint inhibitors. The new invention also provides methods of predicting the efficacy of Ceplene and IL-2 therapy in patients with Acute Myeloid Leukemia.

"This new patent application, if granted, will add substantially to the patent estate surrounding Ceplene," stated Dr. Daniel Teper, Immune's CEO. "The expanded patent life could open up new potential strategic options for the future development of Ceplene in multiple indications."

Ceplene, in combination with low dose IL-2 immunotherapy, met a Phase 3 end point of Progression Free Survival. Ceplene is approved in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia, an orphan indication with poor survival prognosis, for which no effective therapy is available to patients. 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.

"There are no approved treatments for maintaining remission in patients with Acute Myeloid Leukemia," said Dr. Miri Ben-Ami, President and EVP of Oncology. "This is a population with high mortality and an unmet need.  The immune checkpoint blocking agents have resulted in major strides in the treatment of cancer in the past few years, and the addition of Ceplene to these checkpoint blockers may potentially open a new paradigm for the treatment of multiple cancer indications, exploiting a novel immune mechanism to provide the next stride in cancer immunotherapy."

About Immune Pharmaceuticals:

Immune Pharmaceuticals (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 oncology pipeline includes Ceplene®, Azixa® and Crolibulin® as well as bispecific antibodies and nanotherapeutics, including NanomAbs. 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 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.

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SOURCE Immune Pharmaceuticals Inc.

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