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

 

NEW YORK, Feb. 17, 2017  -- 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.

 

About Ceplene®   

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.

 

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, Ceplene, Azixa, AmiKet, AmiKet Nano, LidoPain or NanoCyclo 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; risks associated with the contemplated transaction with NPT. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K 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.immunepharma.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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