Immune Pharmaceuticals Inc., 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.