Immune Pharmaceuticals announces initiation of enrollment in clinical trial with Ceplene®/ low-dose IL-2 in Chronic Myelomonocytic Leukemia (CMML)

NEW YORK, June 20, 2017 /PRNewswire/ -- Immune Pharmaceuticals (NASDAQ:IMNP) ("Immune"), a clinical stage biopharmaceutical company, announced today that patient enrollment in a Phase I/II clinical trial evaluating the safety and efficacy of Ceplene (histamine dihydrochloride) in patients with Chronic Myelomonocytic Leukemia (CMML) is expected to begin in the coming weeks. In this trial, 15 adult patients with CMML will receive Ceplene in conjunction with low-dose Proleukin® (interleukin-2 (IL-2)). This Ceplene/CMML trial is being financed by the University of Gothenburg, Sweden. Cytovia Inc., Immune's immuno-oncology subsidiary, has agreed to provide a non-restricted grant to the University of Gothenburg to cover costs for IL-2 treatment. For more information on this trial, please visit https://clinicaltrials.gov/ct2/show/NCT03040401.

Dr. Daniel Teper commented, "Now that Cytovia has regained worldwide ownership of Ceplene following the transaction with Mylan, we have the opportunity to implement a comprehensive development and commercialization strategy for Ceplene. Chronic Myelomonocytic Leukemia represents a new indication for Ceplene, which fits in well with our strategy to develop new indications beyond Acute Myeloid Leukemia (AML) and to generate new intellectual property covering Ceplene's use."

"CMML cells exert immunosuppression that is targeted by Ceplene," added Professor Kristoffer Hellstrand, MD, PhD, at the Institute of Biomedicine, University of Gothenburg, Sweden. "By reducing immunosuppression, Ceplene improves the function of anti-leukemic immune cells, including T cells and natural killer (NK) cells." Details of the proposed mechanism of Ceplene in CMML are available at https://www.ncbi.nlm.nih.gov/pubmed/28292946.

CMML is a chronic form of leukemia characterized by the accumulation of leukemic monocytes in bone marrow and blood. The Leukemia & Lymphoma Society has estimated that CMML affects approximately three in 100,000 individuals or approximately 10,000 patients  in the United States each year (https://www.lls.org/leukemia/chronic-myelomonocytic-leukemia). Patients with CMML are at high risk for developing AML. The median survival time of CMML patients is estimated at 15-20 months, and there is a significant need for efficacious treatments.

Ceplene, in combination with low-dose Proleukin (interleukin-2 (IL-2)), has been approved in over 30 countries in Europe and in Israel for the treatment of AML for maintenance of remission and prevention of relapse of leukemia. For the vast majority of AML patients there is currently no other approved therapy to prevent relapse.

About Ceplene  
Ceplene (histamine dihydrochloride) is an immunostimulant that is administered in conjunction with low-dose interleukin-2 (IL-2), for maintenance of first remission in patients with AML. Ceplene has been shown in an international Phase III clinical study to prevent relapse of leukemia in AML patients in first remission while maintaining good quality of life during treatment.  Ceplene acts countering dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong pharmacological rationale for this combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research in 2016 supported the safety and efficacy of Ceplene demonstrated in the international Phase III study. Ceplene is approved in 30 European countries and Israel. Ceplene has been granted orphan drug designation for the treatment of AML  in both the United States and in Europe

About AML   
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, and typically become free of detectable leukemia, achieving "complete remission". However, within 1-2 years the majority of adult patients will experience a relapse of leukemia, of which the prognosis for survival is 33% in younger patients and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. AML represents an orphan indication with particularly high unmet need.

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 II 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 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.

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SOURCE Immune Pharmaceuticals Inc.

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