Immune Pharmaceuticals Inc. has filed a patent application directed to the treatment of Acute Myeloid Leukemia and other cancers.
The new invention provides methods of treating cancer by administration of Ceplene (histamine dihydrochloride) in combination with immune checkpoint inhibitors. The new invention also provides methods of predicting the efficacy of Ceplene and IL-2 therapy in patients with Acute Myeloid Leukemia.
“This new patent application, if granted, will add substantially to the patent estate surrounding Ceplene,” stated Dr. Daniel Teper, Immune’s CEO. “The expanded patent life could open up new potential strategic options for the future development of Ceplene in multiple indications.”
Ceplene, in combination with low dose IL-2 immunotherapy, met a Phase 3 end point of Progression Free Survival. Ceplene is approved in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia, an orphan indication with poor survival prognosis, for which no effective therapy is available to patients. Ceplene protects the immune system against inactivation and apoptosis induction by leukemic cells, enabling IL-2-stimulated T cells and Natural Killer (NK) cells to eliminate residual leukemia cells and protect patients against relapse.
“There are no approved treatments for maintaining remission in patients with Acute Myeloid Leukemia,” said Dr. Miri Ben-Ami, President and EVP of Oncology. “This is a population with high mortality and an unmet need. The immune checkpoint blocking agents have resulted in major strides in the treatment of cancer in the past few years, and the addition of Ceplene to these checkpoint blockers may potentially open a new paradigm for the treatment of multiple cancer indications, exploiting a novel immune mechanism to provide the next stride in cancer immunotherapy.”