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Results Announced from Phase 2 Clinical Trial of Ibudilast Suggest Reduction of Brain Atrophy (Shrinkage) in People with Progressive MS

SUMMARY

  • Top-line results were announced of a phase 2 clinical trial testing an oral anti-inflammatory therapy ibudilast (MN-166, MediciNova, Inc.) in people with progressive forms of MS.
  • The results announced in a press release concluded that ibudilast was well tolerated and significantly slowed the rate of brain atrophy compared to placebo. Brain atrophy (shrinkage) has been linked to cognitive and physical disability in MS.
  • The trial was conducted at the Cleveland Clinic and 27 other sites across the U.S., and involved 255 people with primary or secondary progressive MS.
  • The study was principally funded by NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health, with additional support by MediciNova, the company that supplied ibudilast. The National MS Society also provided funding support.
  • Further details are schedule to be presented Saturday, October 28th at the MSParis2017 – 7th Joint ECTRIMS-ACTRIMS Meeting.
  • These phase 2 results may lead the way to the testing of ibudilast in larger phase 3 trial(s), which would be needed before the company could apply for marketing approval from the FDA, the European Medicines Agency or other regulatory agencies. Ibudilast was designated by the FDA as a “Fast Track Product” which could speed its future development as a possible treatment of progressive MS.

“These results sound like a very promising step toward a potential new therapy for people with progressive forms of MS, for whom there are few treatment options,” said Dr. Bruce Bebo, Executive Vice President, Research, National MS Society.

DETAILS
Background: Ibudilast (MN-166, MediciNova, Inc.) inhibits an enzyme called phosphodiesterase, resulting in suppression of inflammation. While considered a “New Molecular Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat cerebrovascular disorders and asthma. It is being also being investigated in the U.S. for its potential to treat ALS and drug addiction.

The study was principally funded by NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health, with additional support by MediciNova, the company that will supply ibudilast. The National MS Society also provided funding support because of its focus on progressive MS and because the trial’s design may answer important questions about the best ways to measure the benefits of therapies aimed at protecting the nervous system from MS.

The study: The trial, known as “SPRINT-MS,” was led by Principal Investigator Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic. It was conducted at the Cleveland Clinic and 27 other sites across the U.S. The trial involved 255 people with primary or secondary progressive MS. The primary outcome measure was change in brain atrophy (as measured by an MRI analysis technique called brain parenchymal fraction) after 96 weeks.  Brain atrophy (shrinkage) has been linked to cognitive and physical disability in MS. Other imaging, safety, clinical and quality of life outcomes were also measured.

The results announced in a press release from MediciNova concluded that ibudilast was well tolerated and significantly slowed the rate of brain atrophy compared to placebo. Further details are schedule to be presented on Saturday, October 28th at the MSParis2017 – 7th Joint ECTRIMS-ACTRIMS Meeting.

What’s Next? These phase 2 results may lead the way to the testing of ibudilast in larger phase 3 trial(s), which would be needed before the company could apply for marketing approval from the FDA, the European Medicines Agency or other regulatory agencies. Ibudilast was designated by the U.S. Food and Drug Administration as a “Fast Track Product” which could speed its future development as a possible treatment of progressive MS.

 

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The Latest on Stem Cell Treatment

Recent media reports have featured news about a clinical trial involving harvesting a person’s own stem cells to treat aggressive multiple sclerosis.
• This treatment, called autologous haematopoietic stem cell transplant (HSCT), attempts to “reboot” the immune system, which is believed to launch attacks on the brain and spinal cord in people with MS.
• HSCT is under investigation in clinical trials in Canada, the United States, Europe and elsewhere. Clinical trials are needed to fully understand the benefits and risks of HSCT in MS, and who might benefit most from this approach, since it does not seem to be effective in all types of MS.
• In HSCT, stem cells from a person’s own bone marrow or blood are stored, and the rest of the individual’s immune cells are depleted usually by chemotherapy. Then the stored stem cells are reintroduced and over time they produce new cells that repopulate the body with immune cells.
• There is exciting progress being made through innovative research related to the potential of many types of stem cells both for slowing MS disease activity and for repairing damage to the nervous system.
• At present, there are no approved stem cell therapies for MS. Stem cell therapy is in the experimental stage, and it’s important for people to have the best available information to understand this exciting area of research and make decisions related to this complex issue.
• In November 2015, the International Conference on Cell-Based Therapy for Multiple Sclerosis was convened by the National MS Society and the European Committee for Treatment and Research in Multiple Sclerosis, bringing leading researchers and clinicians together to confer on clinical trials needed to provide answers about which types of cells, which route of delivery, and which types and stages of disease, would be the most promising approach for treating MS. A summary and consensus on next steps will be published by the conference organizers, with recommendations to help speed the development of new cell-based treatment solutions.
• With the urgent need for more effective treatments for MS, particularly for those with more progressive forms of the disease, we believe that the potential of all types of cell therapies must be explored. The Society is currently supporting 12 research projects exploring various types of stem cells, including cells derived from bone marrow, fat and skin, and has supported 68 stem cell studies over the past 10 years.

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