Immune Pharmaceuticals Receives FDA Guidance for Phase III Pivotal Trial of its AML Therapy Ceplene® In Combination with Low Dose IL-2
Oct 27, 2016
NEW YORK, Oct. 27, 2016 /PRNewswire/ -- Immune Pharmaceuticals (NASDAQ:IMNP) (Immune) announced today that it has received guidance from the United States Food and Drug Administration (FDA) on a phase III study for Ceplene in combination with low dose IL-2 for the maintenance of remission in patients with Acute Myeloid Leukemia (AML). Ceplene/IL-2 has previously been approved in Europe and Israel following a successful phase III study with Leukemia Free Survival as the primary endpoint. The proposed phase III study design reviewed by the FDA focuses on overall survival as the primary endpoint, along with key secondary endpoints, including Leukemia Free Survival.
The FDA also provided feedback relating to specific design elements of the phase III study, and with this framework, Immune plans to submit the final protocol for the phase III study in early 2017 and, upon approval, proceed with conducting a global Phase III Pivotal Overall Survival Study in AML maintenance of response with Ceplene/IL2.
"We are very pleased with the positive outcome of our recent interaction with the FDA. Our path forward to proceed with a pivotal study following regulatory guidance of Ceplene/IL-2 meets our goal to address the urgent unmet medical need for remission maintenance therapy in AML," stated Monica Luchi, MD, Immune's Chief Medical Officer.
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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