Clene presented its data in a session, “Nanocrystalline Gold As a Novel Remyelination Therapeutic for Multiple Sclerosis,” that took place at the third annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in, held Feb. 13 in San Diego.
In MS, demyelination — the loss of the myelin sheaths surrounding neurons — is accompanied by a disturbance in the ability of nerve cells to conduct signals to and from the brain.
CNM-Au8 is an orally administered gold nanocrystal suspension that triggers oligodendrocyte cells to produce new myelin. Oligodendrocyte precursor cells are present in adult brains and have been detected in and around MS lesions. Yet they must be activated into mature oligodendrocytes in order to produce new myelin. CNM-Au8 induces the activation and differentiation of oligodendrocyte precursor cells.
CNM-Au8 has been shown to induce remyelination in multiple animal models of MS. Researchers demyelinated these animal models either by feeding them cuprizone, a toxin, to demyelinate neurons in the central nervous system, or injecting them with lysolecithin to demyelinate spinal nerve axons.
In the lysolecithin model, through the use of Luxol fast blue (LFB) staining, CNM-Au8 was found to induce remyelination. Researchers commonly use LFB to observe myelin under a microscope. Furthermore, behavioral and fine motor assays in cuprizone-treated mice showed that CNM-Au8 restored behavioral function following demyelination.
The results also suggested that CNM-Au8 enhances cellular bioenergetic processes, which most likely helps increase myelination.
One of the major drawbacks to therapies now used to treat MS is that they don’t work to remyelinate MS lesions.
“Remyelination of MS lesions represents an important unmet clinical need unaddressed by current therapies,” Mark S. Freedman, neurology professor at Canada’s University of Ottawa, said in a press release. “Clene’s preclinical remyelination data are very encouraging, and the proposed mechanism of action of enhanced bioenergetics driving cellular differentiation and myelin production is unique and represents a paradigm shift in MS therapeutics.”
Added Clene’s CEO, Rob Etherington: “The therapeutic potential of CNM-Au8 for helping patients with demyelinating disorders is significant. No other drugs approved for the treatment of MS have been shown to remyelinate chronic MS-induced lesions. For this reason, we are looking forward to the launch of our VISIONARY-MS Phase 2 trial in the summer of 2018 with oral administration of CNM-Au8 in adults with relapsing remitting multiple sclerosis who suffer from chronic optic neuropathy.”
Clene, which is headquartered in Salt Lake City, Utah, collaborated with Stephen D. Miller of Northwestern University and Robert H. Miller of George Washington University in these pre-clinical studies.
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