Date: 2016-09-13
Type of information: update on patient enrollment
phase: 2
Announcement: update on patient enrollment
Company: Hybrigenics (France)
Product: inecalcitol
Action
mechanism: vitamin D analog. Inecalcitol has already been granted Orphan Drug status for acute myeloid leukemia both in Europe and the Unites States on the basis of encouraging in vitro and in vivo preclinical results. The molecular basis of the synergy between decitabine, a hypomethylating agent, and inecalcitol has been established: decitabine “unmasks” the gene coding for vitamin D receptors (by reducing the methylation of its promoter region). As a consequence, more vitamin D receptors are expressed and available to be activated by inecalcitol.
Disease: acute myeloid leukemia (AML)
Therapeutic area: Cancer - Oncology
Country: France, USA
Trial details:
Latest
news: * On September 13, 2016, Hybrigenics announced the enrolment in France of the first patient in the Phase II clinical trial of inecalcitol in acute myeloid leukemia. This double-blind placebo-controlled study has been authorized both in France by theNational Drug Safety Agency and in the United States by the FDA with the same protocol. The objective of the study is to focus on the elderly or frail AML patients who are unfit to standard chemotherapy and who can only receive monthly cycles of intravenous perfusions of decitabine (Dacogen®, Johnson & Johnson). In addition to this treatment, they will receive daily oral inecalcitol (4 milligrams per day) or placebo. The primary endpoint will be overall survival. The total number of 110 patients to be included in the study is designed to be sufficiently powered to evidence potential efficacy on mortality. * On January 11, 2016, Hybrigenics announced having received the authorization from the FDA to perform a double-blind placebo-controlled clinical Phase II study of inecalcitol in elderly or frail acute myeloid leukemia (AML) patients in the United States. The study has recently already been approved by the French Drug Agency (see below). The objective of the study is to focus on the elderly or frail AML patients who are unfit to standard chemotherapy and who can only receive monthly cycles of intravenous perfusions of decitabine (Dacogen®, J&J). In addition to this treatment, they will receive oral inecalcitol daily (4 mg/day) or placebo. The primary endpoint will be overall survival. The total number of 110 patients to be included in the study is designed to be sufficiently powered to evidence potential efficacy on mortality. Prof. O. Hermine, Chair of the Department of Hematology, Necker Hospital, Paris, will be the principal investigator of the study in France. Subsequently, Hybrigenics has filed an Investigational New Drug application, to the FDA with the intention to perform part of this clinical Phase II study under the same protocol in the United States. Prof. J. Cortes, Chair of the AML and CML sections, Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, will be the principal investigator in the United States.
* On December 14, 2015, Hybrigenics announced having received the authorization from the French Drug Agency to perform a double-blind placebo-controlled clinical Phase II study of inecalcitol in elderly or frail acute myeloid leukemia (AML) patients in France. Subsequently as planned, Hybrigenics has filed an application to the FDA with the intention to perform part of this clinical study under the same protocol in the United States. Hybrigenics was granted authorization by the French Drug Agency for the Investigational Medicinal Product Dossier (IMPD) of inecalcitol for the AML trial just two months after filing.
