Date: 2013-07-23
Type of information: Grant
Company: ROMANE Consortium (France) The consortium includes AB Science, the Brain and Spine Institute (ICM), MIRCen from the Atomic Energy Commission (CEA), the National Institute of Health and Medical Research (INSERM), Imagine Foundation and Skuldtech.
Investors: Bpifrance (France)
Amount: € 8.6 million
Funding type: grant and repayable avances
Planned used: The funds will be used to develop a new targeted therapy in Alzheimer\'s disease.
Others: * On July 23, 2013, AB Science, a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces the creation of a partnership in the development of a new targeted therapy in Alzheimer\'s disease. The consortium gathers together AB Science, the Brain and Spine Institute (ICM), MIRCen from the Atomic Energy Commission (CEA), the National Institute of Health and Medical Research (INSERM), Imagine Foundation and Skuldtech, a biotechnology company specialized in the discovery of biomarkers and development of diagnostic and testing tools companions.
AB Science, initiator and leader of this project entitled ROMANE (Role of Mast Cells in Neurology), will receive a total amount of € 5.9 million from Bpifrance in the form of grants and repayable advances.
The three main objectives of the ROMANE project are to validate the role of mast cells as a therapeutic target in neurodegenerative diseases, including Alzheimer\'s disease, to develop a targeted therapy, the tyrosine kinase inhibitor masitinib, in Alzheimer\'s disease and to propose new tools for diagnosis and monitoring of patients with Alzheimer\'s disease on the basis of blood biomarkers and new imaging techniques.
INSERM, ICM, MIRCen/CEA and AB SCIENCE will conduct research on preclinical models to assess the role of mast cells in Alzheimer\'s disease and masitinib\'s effect on the symptoms of Alzheimer\'s disease.
These results are anticipated to confirm the clinical benefit of masitinib in Alzheimer\'s disease, and provide better understanding on the mechanism of action of masitinib in this pathology.
Within the framework of this project, AB SCIENCE will conduct a phase 3 study of masitinib in Alzheimer\'s disease, which is already currently recruiting patients. The phase 3 study of masitinib in Alzheimer\'s disease was initiated based upon promising results obtained from a previous phase 2 study, in which masitinib was administered as an add-on therapy to standard care during 24 weeks. Data indicated that masitinib was capable of retarding the rate of cognitive decline of Alzheimer\'s disease as compared against placebo, with an acceptable tolerance profile (Alzheimers Res Ther. 2011 Apr 19;3(2):16. doi: 10.1186/alzrt75)
The third part of the project focuses on the development of imaging markers and genetic biomarkers so that simple and objective tools can be used routinely for the diagnosis and monitoring of patients suffering from Alzheimer\'s disease. Thus, MIRCen/CEA, IMAGINE and AB SCIENCE aim to explore the correlation between response or non-response to masitinib treatment, assessed via validated cognitive parameters and the following diagnostic measures: The cerebral perfusion of patients according to MRI/ASL (Arterial Spin Labeling) and according to another imaging technology based on the administration of a NMR contrast agent (fast stationary method by T1 effect - RSST1);
The load evolution of amyloid plaque via the \"gadolinium staining\" imaging technique with contrast agent.
Finally, Skuldtech, a biotechnology company specialized in the discovery of biomarkers and development of diagnostic tools and companion tests, will use the blood samples collected during the clinical phase conducted by AB SCIENCE, to develop predictive companion tests, based on genetic biomarkers that will predict response or non-response to the treatment. Based on additional blood samples, Skuldtech will also develop in this project a diagnostic test for the evaluation and confirmation of Alzheimer\'s disease development stage.
Therapeutic area: Neurodegenerative diseases
