Rituximab Suppresses Inflammatory Disease in MS, IND Filed for ImmCelz, Laser Ablation Safe in Focal Epilepsy


Neurology News Network for the week ending February 6, 2021.

This week Neurology News Network covered a retrospective study on the effects of discontinuing or lowering rituximab doses in patients with multiple sclerosis, the investigational new drug application of ImmCelz, and results from a study evaluating the safety of magnetic resonance-guided laser interstitial thermal therapy in intractable focal epilepsy.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Results from a retrospective observational study revealed that treatment with rituximab has long-term effects on inflammatory disease activity in patients with multiple sclerosis after discontinuation or dose reduction.Lead author Malin Boremalm, department of clinical Neurosciences, University Hospital of Umea, and colleagues also found that disease reactivation is rare among patients with MS who discontinued treatment for any reason, and that low-dose rituximab is sufficient to maintain suppression of inflammatory disease activity. Among a cohort of 225 patients treated with rituximab, researchers observed no differences regarding the annualized relapse rates (ARRs) during full dose versus reduced dose or off treatment. The study included patients with either relapsing-remitting MS (RRMS) orclinically isolated syndrome (CIS), with patients serving as their own controls by contributing patient years on full dose, reduced dose, and off treatment.

Creative Medical Technology has filed an investigational new drug (IND) application to the FDA requesting clearance to initiate the first clinical trial using its ImmCelz cellular immunotherapy for treatment of stroke, according to a recent announcement.Patients in the proposed study will receive 1 injection of ImmCelz product at 0.5x10(6) cells per kilogram, increasing to 1x10(6) cells per kilogram in the second arm, and 2x10(6) cells per kilogram in the third. Each treatment group will include 8 patients, with a fourth group serving as a control. Both efficacy and safety measures will be observed across the 6-month study period. The mechanism of ImmCelz is unique, utilizing stem cells outside of the body to “reprogram” the patient’s own immune cells to endow upon the immune cells’ regenerative activities, whereas other stem cell-based approaches use significantly smaller immune cells aimed at penetrating areas of the damaged brain and induce regeneration.

Results from a study provide preliminary cognitive and psychological data in support of magnetic resonance-guided laser interstitial thermal therapy (Mrg-LiTT) being a relatively safe surgical approach in patients with intractable focal epilepsy. Senior author Jeffrey Titus, and colleagues included 23 patients with intractable focal epilepsy (52% male) aged 6 to 17 who underwent the Mrg-LiTT procedure and looked at cognitive, behavioral, and quality of life outcomes at pre- and post-surgical neuropsychological evaluation. At 12-month follow-up, sample wide intellectual, fine motor, psychological, and health-related quality of life (HRQOL) outcomes remained generally unchanged; however, researchers observed several different outcomes by post-operative seizure control. Engel Class 1, which is the freedom of disabling seizures, was obtained in 27.6% of patients. The obtainment of Engel Class 2, considered the disabling of seizures or “almost seizure-free,” was found in 13 of 23 (56.5%) patients.

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