Date: 2013-08-06
Type of information:
phase: 1b
Announcement: end of patient recruitment
Company: Trophos (France)
Product: olesoxime as a complementary therapy to MS treatment with interferon beta
Action
mechanism: Olesoxime is one of the cholesterol-oxime compound family of mitochondrial pore modulators, developed for their ability to promote the function and survival of neurons and other cell types under disease-relevant stress conditions through interactions with the mitochondrial permeability transition pore (mPTP).
The mechanism of action of olesoxime involves prevention of mitochondrial dysfunction and improved microtubule dynamics, both implicated in neuroprotection and oligodendrocyte maturation. The ANR-funded MS-Repair project (ANR-08-BIOT-016-01) showed that the molecule is not only neuroprotective, but it also promotes myelination by accelerating the maturation of oligodendrocyte progenitor cells (OPCs) into mature oligodendrocytes. These studies were reported by Trophos and consortium partners from Aix-Marseille University and CNRS, IBDML (UMR 6216) and CRMBM (UMR 6612) in Annals of Neurology (Magalon et al, Ann Neurol. 2012;71:213-26).
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases – Neurodegenerative diseases
Country: France
Trial
details: The trial, led by professor Jean Pelletier (AP-HM/CNRS-CRMBM/CEMEREM), will be conducted in three leading MS clinical centers in France, located in Marseille (AP-HM CHU Timone), Rennes (CHU de Rennes) and Reims (CHU de Reims). Two MRI specialist labs (UMR CNRS 7339-CRMBM/CEMEREM in Marseille and INRIA VISAGES in Rennes) will analyze the imaging biomarker data acquired in the study.
The clinical trial is designed to demonstrate the safety and tolerability of olesoxime as a co-medication with immunomodulatory treatments, interferon beta being the most frequent first line therapy for relapsing remitting multiple sclerosis. The study will also be a pilot study to assess the feasibility of various magnetic resonance imaging (MRI) procedures to detect signs of neuroprotection and/or myelin repair in a multicenter trial. The clinical trial is in preparation for future large-scale clinical trials to assess efficacy of olesoxime to prevent progressive disability in MS patients.
Latest
news: * On August 6, 2013, Trophos, a clinical stage pharmaceutical company developing innovative therapeutics for indications with under-served needs in neurology and cardiology, has announced the end of patient recruitment in its phase 1b study of olesoxime in multiple sclerosis patients as a complementary therapy to their treatment with interferon beta, Translate MS-Repair.
* On March 13, 2013, Trophos has announced the initiation of a phase 1b study of olesoxime in multiple sclerosis patients as a complementary therapy to their treatment with interferon beta. This trial is the objective of an ANR-funded project, Translate MS-Repair, awarded to Trophos and this consortium. Translate-MS-Repair (ANR-12-RPIB-0005-01) is a two-year project aimed at the clinical translation of the results obtained in a previous ANR-funded project: MS-Repair. The clinical Phase 1b study will be a randomized, placebo-controlled, double blind study to evaluate the effect of olesoxime in 42 relapsing remitting MS patients stably treated with all forms of interferon beta. The primary objective is to confirm the safety and tolerability of olesoxime in association with interferon beta. The primary outcome measure is the cumulative incidence of adverse events with the secondary outcome measures being total, new and enlarging brain lesions assessed by MRI. Besides these conventional MRI procedures, a range of non-conventional procedures will be explored including 23Na-MRI, diffusion tensor imaging, magnetization transfer imaging and magnetic resonance spectroscopy in order to assess their feasibility for use as biomarkers of neuroprotection and/or remyelination in a multicenter trial.
