Innate ImmunotherapeuticsMIS416has failed to helpsecondary progressive multiple sclerosis (SPMS) patients in a Phase 2 clinical trial.
The company said it will continue testing the therapy, made up of natural compounds, to see if it can benefit any MS subgroups.
Trial participants who received MIS416 had no meaningful improvements inneuromuscular function or the outcome of their disease, compared with those who took received a placebo.
It is disappointing that these results dont show benefit for people with secondary progressive MS, for whom there are few treatment options, Dr. Bruce Bebo, executive vice president of research at the National MS Society, said in a news release.
Scientists hoped the injected therapy would modulate the activity of immune cells that affect the protective myelin coating around nerve cells,decreasing the inflammation and brain tissue damage associated with MS. Deterioration of the coating is a hallmark of the disease.
The one-year trial (NCT02228213)tested the safety and effectiveness of MIS416 on 93 patients with SPMS in Australia and New Zealand. The patients randomly received MIS416 or a placebo once a week.
There were no differences in the groups scores on a disability index the expanded disability status scale or in brain volume changes detected by magnetic resonance imaging.
In addition, there were no differences between in disease outcomes that patients reported. The self-reported barometers included the Multiple Sclerosis Impact Scale, the Neurological Fatigue Index, and the Brief Pain Inventory.
I am extremely disappointed by this outcome, Professor Pam McCombe, a principal trial investigator, said in a companypress release. Looking for measurable changes in patients with progressive MS using the assessment tools currently at our disposal is frustrating and complicated. We were hopeful that MIS416 would be an option to treat this group of patients who currently do not have effective treatment options.
In addition to MIS416 failing to be effective, the group who received it had more treatment-related adverse events than the placebo group. The events were mainly related to the first dose, Innate said. The main problems were fever, chills, and muscle weakness.
The company has been providing MIS416 to Australian MS patients under a compassionate use program.
It said it will continue evaluating the safety and tolerability of the drug to see if it helps any subgroups of patients. Thosefindings will determine the future of the compassionate use program, it said.
These results are a shock, and definitely not what we were expecting based on our previous clinical experience with MIS416 and the reporting of treatment benefits we have received from many compassionate use patients over an extensive eight-year period, saidSimon Wilkinson, Innate Immunotherapeutics chief executive officer.These data will be as distressing to them as they will be for all the stakeholders who were relying on the outcome of this study.
- Rally for Multiple Sclerosis Treatment Funding - May 7th, 2011 [May 7th, 2011]
- Breakthrough Multiple Sclerosis Treatment? - May 8th, 2011 [May 8th, 2011]
- Multiple Sclerosis Treatment - Mayo Clinic - May 11th, 2011 [May 11th, 2011]
- Tracy Macchia: Controversial MS Treatment - May 14th, 2011 [May 14th, 2011]
- What is Multiple Sclerosis - May 19th, 2011 [May 19th, 2011]
- MS Multiple Sclerosis treatment testimonial from Sanoviv Medical Institute - May 20th, 2011 [May 20th, 2011]
- Patient with progressive ms(paraplegia) Fmr treatment 1/4 - May 22nd, 2011 [May 22nd, 2011]
- New Jersey Multiple Sclerosis Treatment with Chiropractic Care - May 23rd, 2011 [May 23rd, 2011]
- MS Cure - Progression - June 2nd, 2011 [June 2nd, 2011]
- CCSVI UK Multiple Sclerosis Liberation Treatment - June 2nd, 2011 [June 2nd, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl - June 3rd, 2011 [June 3rd, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach Dallas, TX 2011 - June 8th, 2011 [June 8th, 2011]
- MS treatment sees early success - June 9th, 2011 [June 9th, 2011]
- CCSVI Possible cure for Multiple sclerosis - June 10th, 2011 [June 10th, 2011]
- MS Cure - Introduction to stem cell bone marrow transplant in Australia - June 11th, 2011 [June 11th, 2011]
- (Multiple Sclerosis Cure) Change Your Thinking? (Multiple Sclerosis Cure) - June 12th, 2011 [June 12th, 2011]
- Essiac cancer treatment herbal tincture, Ms Caisse...from The Secrets of Eden - June 12th, 2011 [June 12th, 2011]
- MS walking treatment breakthrough - June 14th, 2011 [June 14th, 2011]
- multiple sclerosis natural treatment | Kathy Canada Testimonial - June 18th, 2011 [June 18th, 2011]
- CCSVI Surgery India - Liberation Procedure Multiple Sclerosis Treatment in India - June 29th, 2011 [June 29th, 2011]
- XCell-Center MS CCSVI Liberation Angioplasty Treatment Results E.Schuurman 18_01_11 - July 1st, 2011 [July 1st, 2011]
- MS Cure - 7PM Project Carmel Turner MS Stem Cell Treatment - July 9th, 2011 [July 9th, 2011]
- MS Update! Tysabri or Gilenya? - July 10th, 2011 [July 10th, 2011]
- What causes BSE, CJD - July 15th, 2011 [July 15th, 2011]
- Kath Bartlett, MS, LAc Balance Method Acupuncture - July 16th, 2011 [July 16th, 2011]
- MS Cure - 730 report ben leahy carmel turner ms stem cell treatment - July 17th, 2011 [July 17th, 2011]
- CCSVI LIberation Treatment Tokuda - July 18th, 2011 [July 18th, 2011]
- FOX News Interview on the O'Reilly Factor - Treatment of Women in Islam - July 18th, 2011 [July 18th, 2011]
- CCSVI treatment bloopers holy crap - July 18th, 2011 [July 18th, 2011]
- Tarah's CCSVI Venoplasty. Dr McGuckin Explaining procedure findings - July 19th, 2011 [July 19th, 2011]
- Cancer Cure: The One-Minute Cure For Cancer, MS - July 24th, 2011 [July 24th, 2011]
- Not Ready to Cheer CCSVI Trials - July 29th, 2011 [July 29th, 2011]
- New Oral Treatment for MS - July 30th, 2011 [July 30th, 2011]
- 27/07/2011 - MS patients seek controversial treatment - August 1st, 2011 [August 1st, 2011]
- MS Cure - 11 I am still walking - August 5th, 2011 [August 5th, 2011]
- Upcoming Treatments for MS - Pt 1 -MSRA Public Lecture - Dr Suzanne Hodgkinson - August 10th, 2011 [August 10th, 2011]
- Stem Cells for MS Community Outreach: Patient Judi Lecoq - Dallas, TX 2011 - August 18th, 2011 [August 18th, 2011]
- Stem Cell Treatment for Multiple Sclerosis - Community Outreach, San Diego: David Oliver - August 19th, 2011 [August 19th, 2011]
- New Study Tests Possible Treatment for MS - August 25th, 2011 [August 25th, 2011]
- Professor Dimitrios Karussis: Treating MS - August 26th, 2011 [August 26th, 2011]
- walking with MS before CCSVI treatment.wmv - August 27th, 2011 [August 27th, 2011]
- Suzy Cohen Discusses The Liberation Treatment for MS - September 14th, 2011 [September 14th, 2011]
- Multiple Sclerosis MS People - Amazing New Treatment - September 15th, 2011 [September 15th, 2011]
- Multiple Sclerosis Alternative Treatment - September 17th, 2011 [September 17th, 2011]
- CLEAR scoliosis treatment, Dr. Culpepper (MS) - September 22nd, 2011 [September 22nd, 2011]
- Liberation treatment for MS - September 23rd, 2011 [September 23rd, 2011]
- 44b - My Lyme disease and rheumatoid arthritis journey - Miraculous CCSVI treatment for MS sufferers - September 24th, 2011 [September 24th, 2011]
- A Closer Look at Gilenya - The First Oral Treatment for MS - September 28th, 2011 [September 28th, 2011]
- Unequal Treatment Drives Disability Rights Movement - September 28th, 2011 [September 28th, 2011]
- Multiple Sclerosis - The Nebraska Medical Center - September 29th, 2011 [September 29th, 2011]
- Testimonial for CCSVI Treatment Excel Heart Center Mexico -- Tanya Reay - September 30th, 2011 [September 30th, 2011]
- Current thinking on what causes MS - Pt 1 - MSRA Public Lecture -Prof Graeme Stewart - October 2nd, 2011 [October 2nd, 2011]
- Current and emerging therapies in MS - Part 02 (How do these treatments work?) - October 2nd, 2011 [October 2nd, 2011]
- MS Richard Humphries before and after treatment for Multiple Sclerosis with stem cells - October 3rd, 2011 [October 3rd, 2011]
- Matthew - CCSVI and his Liberation Treatment - October 8th, 2011 [October 8th, 2011]
- Multiple Sclerosis - Myelin Repair - Video - October 14th, 2011 [October 14th, 2011]
- MS Auto Immune vs CCSVI Treatment Simple Pictures by Berukoff - Video - October 23rd, 2011 [October 23rd, 2011]
- New Promising Treatment for Those Living with Multiple Sclerosis - Video - October 29th, 2011 [October 29th, 2011]
- Stem cells to treat MS - Pt 2 - MSRA Public Lecture - A/Prof Richard Burt - Video - October 30th, 2011 [October 30th, 2011]
- New hope for treating multiple sclerosis - Video - October 31st, 2011 [October 31st, 2011]
- CCSVI Multiple sclerosis Breakthrough/cure - Video - October 31st, 2011 [October 31st, 2011]
- Inhuman Treatment of Wheelchair bound Multiple Sclerosis Patient in Canadian Care Home - Video - November 9th, 2011 [November 9th, 2011]
- MS treatment movie Cells4health.mp4 - Video - November 10th, 2011 [November 10th, 2011]
- Racing to the Cure for MS: Myelin Repair Foundation Celebrates MS Awareness Week - Video - November 12th, 2011 [November 12th, 2011]
- [Symptoms of Multiple Sclerosis] - Video - November 12th, 2011 [November 12th, 2011]
- Multiple Sclerosis Treated with Adult Stem Cells - Video - November 13th, 2011 [November 13th, 2011]
- Stem cells to treat MS - Pt 1 - MSRA Public Lecture - A/Prof Richard Burt - Video - November 16th, 2011 [November 16th, 2011]
- Multiple Sclerosis A Natural Treatment - Video - November 16th, 2011 [November 16th, 2011]
- My MS and Stem Cell Treatment - Video - November 16th, 2011 [November 16th, 2011]
- CCSVI Liberation News Reports - Video - November 20th, 2011 [November 20th, 2011]
- Stem Cells for MS Community Outreach: Patient Sam Harrell - Dallas, TX 2011 - Video - November 21st, 2011 [November 21st, 2011]
- Arthur S13 E2-1 - The Silent Treatment - Video - November 27th, 2011 [November 27th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach San Diego CA - Video - December 3rd, 2011 [December 3rd, 2011]
- CCSVI - Video - December 3rd, 2011 [December 3rd, 2011]
- My Sister's Experience with Liberation Treatment for Multiple Sclerosis PART 2/2 - Video - December 5th, 2011 [December 5th, 2011]
- Multiple Sclerosis -- Treatment LDN story - Video - December 7th, 2011 [December 7th, 2011]
- ABC News - Multiple Sclerosis effectively treated by a new acoustic medical device. - Video - December 9th, 2011 [December 9th, 2011]
- MS Patient After Stem Cell Therapy - Video - December 10th, 2011 [December 10th, 2011]
- Multiple Sclerosis - Video - December 12th, 2011 [December 12th, 2011]
- Journey of Connective Tissue, Autoimmune disease, steroid treatment updates. - Video - December 22nd, 2011 [December 22nd, 2011]