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Clene Nanomedicine reports positive results from CNM-Au8, a novel gold nanocrystal remyelinating to treat m sclerosis

Salt Lake City
Tuesday, February 6, 2018, 14:00 Hrs  [IST]

Clene Nanomedicine, a clinical-stage biopharmaceutical company developing a new class of Clean Surface Nanotherapeutic (CSN) drugs using an electro-crystal-chemistry drug development platform, announced results from multiple preclinical studies with CNM-Au8 demonstrating remyelination effects as a potential treatment for multiple sclerosis and other demyelinating disorders. The data were presented in the 'Cutting Edge Developments in MS Research' Session of the third annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held Feb 1-3, in San Diego, California.

CNM-Au8 is a novel orally administered gold nanocrystal suspension. CNM-Au8 demonstrated significant remyelination activity in multiple animal demyelination models of multiple sclerosis. One model used the ingested toxin cuprizone, and the other used injected lysolecithin, to achieve demyelination of CNS neurons and spinal nerve axons, respectively. Statistically significant improvements in remyelination were demonstrated via quantitation of myelin using immunohistochemistry and transmission electron microscopy.  Remyelination was observed in the lysolecithin model using Luxol fast blue staining and immunohistochemistry followed by quantitation of myelin markers, confirming CNM-Au8's robust remyelinating effects. Data demonstrating the catalytic enhancement of cellular bioenergetic processes as the mechanism of action of CNM-Au8 were also presented. Clene Nanomedicine collaborated with Prof. Stephen D. Miller of Northwestern University, and Prof. Robert H. Miller of George Washington University, and their respective labs on these studies.

"Remyelination of MS lesions represents an important unmet clinical need unaddressed by current therapies.  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," observed Dr. Mark S. Freedman, Professor of Neurology, University of Ottawa.

"We are committed to developing a new therapeutic class of treatments that disrupts the old paradigms of drug discovery. CNM-Au8, our lead asset, is realizing this goal. The therapeutic potential of CNM-Au8 for helping patients with demyelinating disorders is significant," said Rob Etherington, CEO of Clene Nanomedicine.  "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."


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