Immune Pharmaceuticals Announces the launch of REMAIN ™ , an international Overall Survival study with Ceplene® and low dose Proleukin® in REmission MAINtenance in Acute Myeloid Leukemia
Ceplene Currently Approved in Europe and Israel
REMAIN™ to be a pivotal study for US approval
Feb 17, 2017
NEW YORK, Feb. 17, 2017 /PRNewswire/ -- Immune Pharmaceuticals Inc. (Nasdaq: IMNP), will announce on Monday, February 20th, 2017 at the Acute Leukemia XVI symposium in Munich, Germany that it will be launching REMAIN™, an international Overall Survival clinical study with the combination of Ceplene®, the Company's flagship product for Acute Myeloid Leukemia (AML) remission maintenance and relapse prevention, and low dose Proleukin®. Patient recruitment is expected to start in later 2017.
Dr Daniel Teper, Chief Executive Officer of Immune Pharmaceuticals, stated, "Remission Maintenance is a significant unmet medical need for patients with Acute Myeloid Leukemia. The combination of Ceplene and low dose Proleukin has demonstrated that it improves LFS, the pre-agreed end point of a prior global Phase 3 study that supported EU approval, and additional studies have shown that LFS and OS exhibit a strong correlation. REMAIN is an important study to confirm the role of immunotherapy in AML. REMAIN will be conducted in collaboration with Meda, who currently holds the rights to Ceplene in Europe and Asia.
The combination is already approved in Europe and Israel, on the basis of a successful Leukemia Free Survival phase 3 study. Immune has received guidance from the FDA regarding the design of a pivotal study for US approval evaluating Ceplene in combination with low dose Proleukin (IL-2) compared to low dose Proleukin alone. Immune plans to enroll over 400 patients worldwide with the primary endpoint being overall survival (OS) at two years and the secondary endpoint of the study being leukemia-free survival (LFS) at one year.
REMAIN will be financed exclusively through Cytovia Inc, the Immuno-oncology subsidiary of Immune Pharmaceuticals.
Ceplene® (histamine dihydrochloride) is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). It has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival while maintaining good quality of life during treatment. Ceplene acts by enhancing the immunostimulatory effect of IL-2 and countering ROS-induced dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong pharmacokinetic rationale for this combination therapy.
About Acute Myeloid Leukemia (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 (75-80%) of adult patients will experience a relapse of leukemia, of which survival prognosis is extremely poor especially in patients over 60 years of age (15-20%). With ~20000 new cases in the US in 2015, poor prognosis following first remission and no other effective remission therapies currently available, AML represents an orphan indication with particularly high unmet need.
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 Non-Alcoholic Steato-Hepatitis (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® which is in late stage clinical development for maintenance remission in Acute Myeloid Leukemia (AML) in combination with IL-2. Additional oncology pipeline includes Azixa® and crolibulin, Phase II clinical stage vascular disrupting agents, and novel technology platforms; bispecific antibodies and NanomAbs™. Maxim Pharmaceuticals Inc., Immune's pain and neurology subsidiary is developing AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain. For more information, 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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