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Strengthens Intellectual property portfolio and expands potential clinical use and market opportunity
Cytovia, the oncology subsidiary of Immune Pharmaceuticals (NASDAQ:IMNP) ("Immune" or the “Company”), a clinical stage biopharmaceutical company, today announced the publication of new results supporting the benefits of its lead compound Ceplene® (histamine dihydrochloride). In parallel, Cytovia has filed a world-wide patent to protect the use of Ceplene® in CML. In the British Journal of Haematology new publication (https://www.ncbi.nlm.nih.gov/pubmed/28542840), the authors show that the genetic elimination of NOX2 function delayed the development of CML in mice and prolonged survival. These results support that Ceplene®, or other inhibitors of NOX2 function, may be efficacious in CML.
In the US, there are approximately 100,000 patients living with CML. The patients receive tyrosine kinase inhibitors including imatinib (Gleevec®, Glivec®), which have dramatically improved long-term survival. However, treatment with Gleevec® or other tyrosine kinase inhibitors is typically life-long with high medication costs and significant side-effects to therapy.
During treatment with tyrosine kinase inhibitors in CML, a small clone of leukemic cancer cells persists in most patients. Hence a method to further reduce or eliminate the burden of leukemic cancer cells would be of benefit to patients with CML.
“Inhibition of NOX2 is a novel and conceivable strategy to reduce the burden of malignant cells in patients with CML,” said Kristoffer Hellstrand, MD, PhD and professor of tumor immunology at the University of Gothenburg, Sweden. “We are interested in evaluating the potential efficacy of the combination of Ceplene® and low-dose IL-2 in CML patients.”
Dr. Daniel Teper, CEO of Cytovia adds: “We are delighted of the renewed scientific interest in Ceplene as demonstrated by the high quality data published in peer reviewed journals and the new patent filings. The spin-off of Cytovia from Immune will provide us the focused resources to commercialize Ceplene in AML, initiate clinical studies in new indications, including CML, and potentially expand Ceplene market opportunity.”
Ceplene® (histamine dihydrochloride) is an immunostimulant that is approved for use in over 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 activation of 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 over 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.
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.
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