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CYTOVIA Inc, IMMUNE Pharma’s Oncology Subsidiary, Announces Publication of Results Showing Anti-Metastatic Properties of Its Lead Drug Ceplene® and Filing of a New Worldwide Patent

09:30 EDT 9 Aug 2017 | Businesswire

Additional potential in cancer immunotherapy with Ceplene in combination with Interleukin-15 (IL-15)

Cytovia, the oncology subsidiary of Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune"), a clinical stage biopharmaceutical company, today announced the publication of results showing favorable effects of its lead immunotherapeutic compound Ceplene® (histamine dihydrochloride) in cancer.

The results of the new article confirm and extend previous findings showing that treatment of mice with Ceplene® efficiently reduces the formation of lung melanoma metastases. Using genetically modified mice, the authors also show that the beneficial effect of treatment with Ceplene® in reducing metastasis was likely explained by its inhibitory effect on NOX2, which is an enzyme expressed by myeloid blood cells. In the article, the investigators additionally report that combination immunotherapy with Ceplene® and interleukin-15 (IL-15) reduced melanoma metastasis by over 70%, an incremental effect over Ceplene alone or IL-15 alone.

The article was published in Cancer Immunology Research and is found on this link: https://www.ncbi.nlm.nih.gov/pubmed/28760732

“Cytovia has recently filed a patent aiming to protect the use of Ceplene® and other inhibitors of NOX2 in reducing or preventing cancer metastasis,” said Dr. Daniel Teper, CEO of Cytovia. He added: “The reduction of metastasis obtained by the combination of Ceplene® and IL-15 is suggestive of a novel combinatorial immunotherapy that merits further study.”

About Ceplene

Ceplene® (histamine dihydrochloride) is an immunostimulant that is approved for use in >30 countries in Europe for the maintenance of first remission in patients with acute myeloid leukemia (AML). Ceplene® is administered in conjunction with low-dose IL-2 for enhanced anti-tumor immunity. Specifically, Ceplene® acts by countering NOX2-mediated immunosuppression and thus improves activation of anti-tumor lymphocytes such as T cells and NK cells. When administered together with the T cell/NK cell activator IL-2, Ceplene® promotes immune-mediated killing of cancer cells, thus providing a strong pharmacological rationale for this combination immunotherapy. Aspects on the effects of Ceplene® on anti-tumor immunity have been reported in >50 scientific articles.

In an international Phase III clinical study in 320 AML patients, the combination of Ceplene® and low-dose IL-2 has been shown to prevent relapse of leukemia while maintaining good quality of life during treatment. A recent Phase IV study in 84 AML patients demonstrated efficient activation of anti-tumor immunity during treatment with Ceplene®/IL-2 and also identified tools that may prognosticate the clinical benefit of the treatment. During 2015-17, detailed results of the Phase IV study were presented in several medical journals including Leukemia, a leading journal in hematology. Following the recent acquisition from Mylan, Cytovia holds worldwide rights for Ceplene®.

About Immune Pharmaceuticals Inc.

Immune Pharmaceuticals Inc. (NASDAQ: IMNP) is dedicated to alleviating the burden of patients suffering from autoimmune diseases by developing novel immunotherapeutic agents. Immune's lead product candidate, bertilimumab, is in Phase 2 clinical development for bullous pemphigoid, an orphan autoimmune dermatological condition, and for ulcerative colitis. Other potential relevant indications for bertilimumab include atopic dermatitis, Crohn's disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH). Also, Immune’s pipeline includes topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis and AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain.

Immune's oncology subsidiary, Cytovia, plans to develop and commercialize Ceplene for maintenance remission in AML in combination with IL-2. Additional oncology pipeline products include Azixa® and crolibulin, which are clinical stage vascular disrupting agents, and bispecific antibodies and NanomAbs™, which are novel technology platforms.

For more information, please visit Immune's website at www.immunepharma.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, may 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. Forward-looking statements include, among others, statements regarding the Company's ability to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. 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.

There can be no assurance that the Company will ever successfully complete its anticipated corporate restructuring, or that the Company will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. Factors that may cause actual results or developments to differ materially include, but are 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 ongoing or future clinical trials will not be successful; the risk that our compounds under development 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 future trials or commercialize our product candidates on attractive terms, on a timely basis or at all; the risk that our product candidates that appear 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 our 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.immunepharma.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 (including those relating to the corporate reorganization and exploration of strategic alternatives), whether as a result of new information, future events or otherwise, except as required by law.

For Cytovia, Inc.
Daniel Teper
investors@immunepharma.com

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