NEW YORK, June 7, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. ("Immune"), a biopharmaceutical company focused on the development of antibody-based therapeutics for the treatment of inflammatory diseases and cancer, and Hadasit, the Technology Transfer company of The Hadassah Medical Organization in Jerusalem, Israel, announced today that they together filed a provisional patent on the oral use of anti-eotaxin monoclonal antibodies, including Immune's bertilimumab, for the treatment of inflammatory gastro-intestinal (GI) and liver diseases. Immune signed a licensing agreement with Hadasit in conjunction with the provisional patent filing.
"Oral administration of a non-absorbable mouse anti-eotaxin-1 antibody showed biological activity in the gut, and exerted a systemic immuno-modulatory effect to alleviate immune-mediated hepatitis in an animal model. The data suggests that testing for eotaxin-1 serum levels, and using oral bertilimumab, a fully human monoclonal antibody, may enable the identification and treatment of patients with high-eotaxin-1-associated NASH," said Professor Yaron Ilan, Professor of Medicine, Gastro-Enterology and Liver Units and Director, Department of Medicine at Hebrew University's Hadassah Hospital in Jerusalem, Israel, who conducted the research supporting the provisional patent application.
Immune is currently conducting a double blind placebo controlled phase IIA clinical trial in Ulcerative Colitis, with parenteral bertilimumab. Immune is currently collaborating with Professor Arun Sanyal, former President of the American Liver Association, and Professor of Medicine at Virginia Commonwealth University (VCU) Medical Center to obtain additional insights on the potential role of eotaxin in NASH. Phase II clinical trials in patients with NASH are planned to follow these collaborative studies.
Eotaxin-1, a specific chemokine, plays a role in both innate and adaptive immune responses and modulates the cross-talk between key cells involved in inflammation. Bertilimumab is a first-in-class monoclonal antibody that blocks eotaxin-1, is designed for personalized therapy in inflammatory conditions mediated by high eotaxin-1 levels, among which are Crohn's Disease and Ulcerative Colitis, NASH, and primary sclerosing cholangitis (PSC). Alleviation of insulin resistance is also associated with decreased eotaxin-1.
"Personalized therapies may help provide an optimized safety-to-efficacy ratio by selecting patients with higher response rates based on specific biomarkers," adds Professor Ilan.
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.
About Hadasit
Hadasit is the Technology Transfer company of the Hadassah Medical Organisation in Jerusalem, Israel.. The Hadassah Medical Center, established 100 years ago and regarded as one of Israel's primary hospitals, has accumulated a vast amount of knowledge, medical research, dedication and innovation. The combination of practical experience, ability to pinpoint medical needs and cutting-edge research has yielded a huge potential of ideas, innovation and developments in all aspects of medicine, including therapeutics, diagnostics and medical devices.
In order to realize this potential, Hadassah established Hadasit – the business arm which was founded in 1986 as its vehicle for commercialization of medical technologies developed at the hospitals – and has been investing in turning ideas into viable products and services for the benefit of humanity. Hadasit collaborates with leading international companies and research facilities, such as Johnson & Johnson, Harvard Medical School, Teva and others, as well as incubators and venture capital groups such as BiolineRx, Clal Biotechnologies and Pontifax. Hadasit investment and partner companies include Alcobra, Oramed, Kahr Medical, Imuron and others.
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. 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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"Oral administration of a non-absorbable mouse anti-eotaxin-1 antibody showed biological activity in the gut, and exerted a systemic immuno-modulatory effect to alleviate immune-mediated hepatitis in an animal model. The data suggests that testing for eotaxin-1 serum levels, and using oral bertilimumab, a fully human monoclonal antibody, may enable the identification and treatment of patients with high-eotaxin-1-associated NASH," said Professor Yaron Ilan, Professor of Medicine, Gastro-Enterology and Liver Units and Director, Department of Medicine at Hebrew University's Hadassah Hospital in Jerusalem, Israel, who conducted the research supporting the provisional patent application.
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Immune is currently conducting a double blind placebo controlled phase IIA clinical trial in Ulcerative Colitis, with parenteral bertilimumab. Immune is currently collaborating with Professor Arun Sanyal, former President of the American Liver Association, and Professor of Medicine at Virginia Commonwealth University (VCU) Medical Center to obtain additional insights on the potential role of eotaxin in NASH. Phase II clinical trials in patients with NASH are planned to follow these collaborative studies.
Eotaxin-1, a specific chemokine, plays a role in both innate and adaptive immune responses and modulates the cross-talk between key cells involved in inflammation. Bertilimumab is a first-in-class monoclonal antibody that blocks eotaxin-1, is designed for personalized therapy in inflammatory conditions mediated by high eotaxin-1 levels, among which are Crohn's Disease and Ulcerative Colitis, NASH, and primary sclerosing cholangitis (PSC). Alleviation of insulin resistance is also associated with decreased eotaxin-1.
"Personalized therapies may help provide an optimized safety-to-efficacy ratio by selecting patients with higher response rates based on specific biomarkers," adds Professor Ilan.
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.
About Hadasit
Hadasit is the Technology Transfer company of the Hadassah Medical Organisation in Jerusalem, Israel.. The Hadassah Medical Center, established 100 years ago and regarded as one of Israel's primary hospitals, has accumulated a vast amount of knowledge, medical research, dedication and innovation. The combination of practical experience, ability to pinpoint medical needs and cutting-edge research has yielded a huge potential of ideas, innovation and developments in all aspects of medicine, including therapeutics, diagnostics and medical devices.
In order to realize this potential, Hadassah established Hadasit – the business arm which was founded in 1986 as its vehicle for commercialization of medical technologies developed at the hospitals – and has been investing in turning ideas into viable products and services for the benefit of humanity. Hadasit collaborates with leading international companies and research facilities, such as Johnson & Johnson, Harvard Medical School, Teva and others, as well as incubators and venture capital groups such as BiolineRx, Clal Biotechnologies and Pontifax. Hadasit investment and partner companies include Alcobra, Oramed, Kahr Medical, Imuron and others.
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. 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.
