brain lesions

Celgene Seeking FDA Approval for Ozanimod to Treat Adults With Relapsing MS

An application has been submitted to approve ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis in the U.S., according to its developer, Celgene. “New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” Jay Backstrom, MD, Celgene’s chief medical officer, said in a press release. Celgene's New Drug Application has been submitted to the U.S. Food and Drug Administration. Earlier this month, the company submitted a marketing authorization application to the European Medicines Agency covering the treatment of adults with relapsing-remitting MS. “With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of (relapsing MS) in 2020,” Backstrom said. Ozanimod is designed to cause the retention of immune cells in lymphoid tissues, thereby blocking their migration to the central nervous system — brain and spinal cord — and preventing damage to nerve fibers and their protective layer, called myelin. The investigational therapy selectively binds to S1P receptor subtypes S1P1 and S1P5. The NDA application is based on positive findings from two multicenter, double-blind, Phase 3 trials called SUNBEAM and RADIANCE part B. Both studies demonstrated that ozanimod reduced the number of relapses and brain lesions. In the SUNBEAM Phase 3 trial, 1,346 participants with relapsing MS were randomized to one daily dose of 0.92 or 0.46 mg of ozanimod — equivalent to 1 mg and 0.5 mg of the therapy’s HCI formulation — or Avonex (interferon beta-1a, marketed by Biogen) for at least 12 months. Results showed that treatment with ozanimod led to fewer relapses and brain lesions, as well as clinically meaningful improvements in processing speed compared with Avonex. In the Phase 2/3 RADIANCE trial, patients were divided in two parts: in part A, participants received either one daily dose of ozanimod (0.5 mg or 1.0 mg) or a placebo for 24 weeks; in part B, a 96-week open-label extension study completed by 223 patients, those initially on placebo switched to ozanimod. As in the SUNBEAM trial, results of part A of the RADIANCE trial revealed a reduction in the number of brain lesions from weeks 12 to 24, as well as less frequent relapses compared with a placebo. Treatment with ozanimod was safe and well-tolerated. Findings of part B of the study included an increased percentage of patients free of T1 lesions on MRI (magnetic resonance imaging) scans — which refer to areas of active inflammation and disease activity — after two years of treatment, from 58.5–69.0% of patients in part A to 86.5–94.6% of patients in part B. T2 lesions, a measure of the total amount of MRI lesions — both old and new — and relapse rate remained low in patients maintained on ozanimod (more significantly with the higher dose of 1.0 mg), and dropped in those who switched from a placebo. The scientists also analyzed ozanimod’s benefits using data from the SUNBEAM and RADIANCE part B trials, which covered 2,659 patients treated over one to two years. Compared with Avonex, ozanimod reduced the annualized relapse rates — the number of relapses per year — by 42% in the higher dose group and 26% in the lower dose group. Treatment with ozanimod also lessened the relapse rate requiring steroid treatment or hospitalization by 43% (in the 1 mg dose group) and 26% (in the 0.5 mg dose group) compared with Avonex treatment. In addition to MS, ozanimod is also being developed for patients with ulcerative colitis and Crohn's disease, two inflammatory bowel diseases.

Is There a Connection Between Fibromyalgia and MS?

I’ve often wondered if there may be a connection between fibromyalgia, multiple sclerosis (MS), and other neurological conditions. Back in the early 1990s, my doctor suspected fibromyalgia as the culprit for my fatigue, aches, and pains. At the time, doctors diagnosed fibromyalgia by the use of tender points.

Retroviral RRMS Treatment GNbAC1 Fails Phase 2 Trial, But Research Continues, Say Sponsors

A Phase 2b trial assessing the experimental retroviral-targeting treatment GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS) failed to meet its primary goal of reducing brain lesions and other signs of brain inflammation within six months. But researchers at GeNeuro and Servier — the two European companies that jointly developed the drug…

RRMS Patients at Risk of PML Can Safely Switch from Tysabri to Lemtrada

Lemtrada (alemtuzumab) may be an effective option for relapsing-remitting multiple sclerosis (RRMS) patients withdrawing from prior treatment with Tysabri (natalizumab), an Italian study shows. The study, “High-Risk PML Patients Switching from Natalizumab to Alemtuzumab: an Observational Study,” appeared in the journal Neurology and Therapy. Tysabri, an antibody with…

Apitope Regains Full Rights to Potential MS Therapy, ATX-MS-1467

Apitope and Merck KGaA announced that they have entered into an exclusive agreement regarding ATX-MS-1467, a potential disease-modifying therapy for  multiple sclerosis (MS). Under its terms, Apitope will regain full global rights over ATX-MS-1467, as well as all clinical data related to the compound. In 2009, the company granted exclusive global rights to Merck KGaA to develop…

Coherus’ Oral Therapy for Relapsing MS Seen to Reduce Brain Lesions by Half in Phase 2b Trial

Coherus BioSciences recently reported that its candidate therapy for multiple sclerosis (MS), CHS-131, reduced the development rate of new brain lesions by nearly 50% in previously untreated relapsing-remitting MS patients. The Phase 2b trial (NCT02638038), randomizing patients to receive either CHS-131 or placebo in a double-blind manner, also showed the…

#CMSC16 – Fingolimod (Gilenya) Offers Consistent Health Benefits in Relapsing-Remitting MS Patients

Researchers at the Swedish Neuroscience Institute in Washington and Novartis Pharma revealed that Gilenya (fingolimod) induced a consistent and significant reduction in disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). The results were recently presented at the June 1-4 Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual…

Experimental RRMS Therapy, Trimesta, Fails to Demonstrate Efficacy in Review of Clinical Trial

Synthetic Biologics, Inc., a clinical stage company focused on the development of therapeutics to protect the microbiome and to target disease-causing pathogens, recently announced disappointing results from an independent third-party analysis of a Phase 2 clinical trial evaluating Trimesta as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women.

Targeting B-cell Activity May Reduce MS Brain Lesions, According To GlaxoSmithKline-Backed Study

New research work from GlaxoSmithKline presented by Daren Ausin, PhD, at the American Academy of Neurology’s 66th Annual Meeting has implications for individuals with relapsinig-remitting multiple sclerosis. The presentation detailed a study that used GlaxoSmithKline’s ofatumumab in 231 patients with relapse-remitting multiple sclerosis. Ofatumumab is an anti-B-cell antibody, and it…