#ACTRIMS2018

New Ocrevus Data, Post-FDA Approval, Supports Range of Benefits, Genentech’s Hideki Garren Says

OcrevusĀ (ocrelizumab), Genentechā€™sĀ humanized anti-CD20 monoclonal antibody, continues to show clear evidence that it helps to slow disease progression and enable better function ā€” including in the hands and limbs ā€” ofĀ relapsing multiple sclerosis (MS)Ā and primary progressive multiple sclerosis (PPMS), latest data reveals. TheĀ first FDA-approved therapy ā€” in March…

Good News for Tysabri Users Who Are JCV Positive

One of the many disease-modifying therapies (DMTs) that I’ve been on over the many years of my treatment for MS is Tysabri (natalizumab). It worked well, holding the progression of my MS at bay for the several years that I received the infusions. I’d probably still be on it…

#ACTRIMS2018 ā€“ Third Course of Lemtrada Improves Relapse, Disability in MS Patients, CARE-MS II Trial Shows

Multiple sclerosis (MS) patients who experience a relapse after two courses ofĀ Lemtrada (alemtuzumab)Ā treatment showed improvements inĀ relapse rate and disability after aĀ third Lemtrada course, according to results of the CARE-MS II trial extension. The poster reporting the findings, titled ā€œEfficacy of Alemtuzumab Retreatment in Patients Who Experienced Disease Activity after…

#ACTRIMS2018 ā€“ Combo Can Stop Tysabri-related PML Infection from Worsening, Case Study Shows

A combination of an anti-viral therapy and the anti-depressive mirtazapine can stop the worsening of an infection linked to the multiple sclerosis therapyĀ Tysabri (natalizumab), a case study suggests. The infection, John Cunninghan polyomavirus, can cause a potentially fatal brain infection known as Ā progressive multifocal leukoencephalopathy, or PML. Both…

#ACTRIMS2018 – MS Therapy MD1003’s Disability Improvements Hold Over Time, Study Shows

MedDay Pharma’sĀ MD1003Ā leads to long-lasting improvements in progressive multiple sclerosis patients’ disability, a Phase 3 clinical trial follow-up study shows. Researchers presented the results at the thirdĀ Annual Americas Committee for Treatment and Research in Multiple Sclerosis ForumĀ in San Diego, Feb. 1-3. The poster presentation was titledĀ ā€œ…

#ACTRIMS2018 – Clene Nanomedicine Presents Positive Results for MS Remyelinating Therapy

Clene Nanomedicine says its pre-clinical studies demonstrate the remyelination effects of CNM-Au8, supporting its potential to treat multiple sclerosis (MS) and other demyelinating disorders. Clene presented its data in a session,Ā “Nanocrystalline Gold As a Novel Remyelination Therapeutic for Multiple Sclerosis,”Ā thatĀ took place at the third annual Americas…

#ACTRIMS2018 ā€“ Extending Tysabri Treatment Intervals May Reduce PML Risk, TOUCH Registry Data Suggest

Extending the dosing periods of Tysabri (natalizumab) treatment may help reduce the risk of progressive multifocal leukoencephalopathy, or PML, in multiple sclerosis (MS) patients infected with the JC virus, a study suggests. The study, ā€œNatalizumab Extended Interval Dosing Is Associated with a Reduction in Progressive Multifocal Leukoencephalopathy…

#ACTRIMS2018 ā€“ MediciNova Presents Positive Results from SPRINT-MS Trial Evaluating Ibudilast in Progressive MS

Top-line results from a clinical trial evaluating the investigational oral therapy ibudilast for progressive multiple sclerosis (MS) show that the therapy led to a significant reduction of brain atrophy in patients when compared to controls. Robert Naismith, MD, one of the study’s principal researchers fromĀ Washington University in St. Louis,…

#ACTRIMS2018 – Relapsing MS Patients With Impaired Vision Improved on Ocrevus, Updated Trial Data Show

Ocrevus improved vision among relapsing multiple sclerosis patients who participated in the Phase 3 clinical trials of the treatment, according to updated analyses recently presented at the ACTRIMSĀ Forum 2018. While Ocrevus-treated patients improved their ability to read low-contrast letters over the course of the two trials, people who received Rebif (interferon beta-1a) did not. Laura J. Balcer, a neurologist at New York University Langone Medical Center, shared the data in a presentation titled, ā€œEffect of Ocrelizumab on Visual Outcomes in Patients with Baseline Visual Impairment in the OPERA Studies in Relapsing Multiple Sclerosis.ā€ Balcer had earlier shared data on the visual outcomes of relapsing patients in the OPERA I and OPERA II Phase 3 clinical trials of Ocrevus at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, last year. The two studies ā€”Ā sponsored by Ocrevus developer Genentech, a member of the Roche group ā€” Ā compared Ocrevus and Rebif in patients with relapsing MS. This time, her presentation focused only on patients who had visual impairment when they enrolled in the trials. Among a total of 1,656 participants, 375 of those treated with Ocrevus and 373 in the Rebif group had visual impairment. Researchers tested vision using a low-contrast letter acuity test. The test is similar to an ordinary vision test, with letters of different sizes on a chart. But the low-contrast test uses gray lettersĀ ā€” instead of black ā€” on a white background. Researchers included charts with two shades of gray to test different contrast levels. These tests can detect reduced visual function. At the beginning of the trials, both groups performed in a similar manner ā€”Ā correctly identifying about 35 letters on a chart with somewhat higher contrast. After 96 weeks, those receiving Ocrevus identified on average 3.4 more letters, while Rebif-treated patients worsened by 0.5 letters ā€” a significant difference, Balcer said. Researchers tested vision every 12 weeks. At the end of the trials, they found that 39 percent more patients in the Ocrevus groups had a cumulative improvement of at least 10 letters, compared to those treated with Rebif. At this time, 26.4 percent of Ocrevus-treated patients improved 10 letters or more, compared to 19.8 percent in the Rebif group. The difference between the groups for at least seven letters was 54 percent, with Ocrevus-treated patients performing better. Researchers believe that a seven-letter change is the minimal clinically important difference for the test. Based on the results, researchers believe that the findings demonstrate Ocrevusā€™ ability to reverse visual impairment in relapsing MS. The ACTRIMS Forum 2018 isĀ being held in San Diego, California, Feb. 1ā€“3.

#ACTRIMS2018 – Oryzon Enrolls First Patient in SATEEN Trial, Presents New Data at MS Meet

Oryzon GenomicsĀ has enrolled the first multiple sclerosis patient in its Phase 2a SATEEN clinical trial investigating the therapy ORY-2001. The Spanish company will also present new results from preclinical models of MS treated with ORY-2001 at theĀ Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018, set for Feb. 1-3 in San Diego. ORY-2001 is an epigenetic therapy, meaning it targets the expression and activity of genes. The drug inhibits two particular molecules, LSD1 and MAOB, and was previously shown to reduce cognitive impairment and neuroinflammation in preclinical models, including in a mouse model of MS ā€” the experimental autoimmune encephalomyelitis (EAE) model. The therapy was also shown to have neuroprotective effects. During ACTRESS 2018, Oryzon's chief scientific officer, Tamara Maes, will present a poster, "ORY-2001 reduces inflammatory cell infiltration in the Theilerā€™s murine encephalomyelitis virus model and highlights the epigenetic axis in MS.ā€ ā€œIn previous reports we showed that ORY-2001 reduces the clinical score, lymphocyte egress, immune cell infiltration and inflammation protecting the spinal cord from demyelination in a murine MS-EAE model,ā€ Maes said in a press release.Ā ā€œHere we provide data on the efficacy of ORY-2001 in the Theilerā€™s murine encephalomyelitis virus model for multiple sclerosis." In a second poster, "ORY-2001 in multiple sclerosis: first clinical trial of a dual LSD-1/MAOB inhibitor,ā€ Roger Bullock, Oryzon's chief medical officer, will detail the Phase 2a trial, SATEEN, testing ORY-2001 in patients with relapsing-remitting or secondary progressive MS over a 36-week period, followed by an open-label extension. ā€œOur first patient enrolled in SATEEN signals a new landmark for the clinical development of this drug in different neurological indications,ā€ said Bullock. ā€œThis is the first epigenetic approach in this disease, and we hope that it will contribute to enlarge and improve the therapeutic options for patients afflicted by MS."

#ACTRIMS2018 – Ublituximab Led to Major Drop in MS Brain and Spine Lesions, Trial Shows

TG Therapeutics‘ ublituximab (TG-1101) led toĀ a remarkable reduction in multiple sclerosis patients’ brain and spine lesions, a Phase 2 clinical trial showed. In fact, none of the treated patients had new gadolinium-enhancing lesions ā€” or damaged nerve cell areas ā€” six months after treatment, researchers said.Ā Their analysis covered patients…