Ned Sharpless as Acting FDA Commissioner, Temelimab in MS Extension Trial, and Post-Stroke Blood Panel Predicting Dementia

This week, Neurology News Network covered Ned Sharpless, MD, the director of the National Cancer Institute, being named to the position of acting FDA Commissioner, the findings from the ANGEL-MS study, and a study that revealed a peripheral immune response occurring 2 days after an ischemic stroke that strongly predicts the likelihood of losing substantial mental acuity within 1 year. (Transcript below)

Jenna:

Welcome to Neurology News Network. I’m Jenna Payesko. Let’s get into the news from this week.

Ned Sharpless, MD, the director of the National Cancer Institute, has been named to the position of acting FDA Commissioner, effective next month once the current commissioner’s resignation is final.

The announcement was made by the Trump administration just a week after the current commissioner, Scott Gottlieb, MD, announced his plans to resign in early April. Sharpless has been the head of the National Institutes of Health’s (NIH) cancer center since October 2017. He also works as the chief of the aging biology and cancer sections of the National Institute on Aging’s Laboratory of Genetics and Genomics.

“Dr. Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” Alex M. Azar, the secretary of Health and Human Services, said in a statement. “There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”

The findings from the ANGEL-MS study have shown that treatment with temelimab for a 2-year period had a continued, positive impact on measures of disease progression in MS.

The 2-year safety and efficacy extension of the CHANGE-MS trial ultimately showed encouraging dose-dependent effects with the 18-mg/kg dose on confirmed 12-week EDSS scores and the 25-foot timed walk. Data showed a relative reduction in brain atrophy with the highest dose compared to the control group of 42% and 43% in the cortex and thalamus, respectively. The 18-mg/kg treatment arm also showed a lower probability for 12-week confirmed disability progression.

A search for biomarkers of functional and cognitive outcomes after a stroke has revealed a peripheral immune response occurring 2 days after an ischemic stroke that strongly predicts the likelihood of losing substantial mental acuity within 1 year.

When regressed against the change in the Montreal Cognitive Assessment scores between day 90 and day 365 after the occurrence of stroke, the acute inflammatory phase Elastic Net model correlated with post-stroke cognitive trajectories. This, the authors indicated, suggests the helpfulness of immune profiling with mass cytometry to identify clinically relevant immune correlations with long-term cognitive trajectories.

Lead author Marion Buckwalter, MD, PhD, told NeurologyLive that "being able to identify, early on, patients who are at risk for dementia is a first step toward figuring out how to treat those at-risk patients.”

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.