Cell Therapy HLCM051 Falls Short in Stroke Study, Benefits of Light Therapy in Alzheimer, IPL344 Phase 2a Data Released

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

In a recently published phase 2/3 randomized clinical trial (NCT02961504), treatment with HLCM051 (Lonza), a bone marrow-derived, allogenic, multipotent progenitor cell product, did not improve short-term outcomes in patients with acute ischemic stroke (AIS) despite being safe. Investigators concluded that additional research is needed to see whether the therapy has a beneficial effect in patients who meet specific criteria, as indicated by the exploratory analyses in the study. Also known as TREASURE, the multicenter, double-blind, parallel-group trial included 206 patients with AIS who received either intravenous HLCM051 (n = 104) in 1 single unit of 1.2 billion cells or placebo (n = 102) within 18 to 36 hours of ischemic stroke onset.

In a recently published meta-analysis of 15 randomized controlled trials (RCTs), results showed that light therapy has significant beneficial effects for patients with Alzheimer disease (AD), demonstrated by improvements in sleep and psychobehavioral symptoms. Published in PLOS One, the analysis included studied with older adults (aged 60-85 years) diagnosed with AD and had Mini-Mental State Examination (MMSE) scores between 6 and 26. Patients in the intervention group had undergone light therapy, whereas those in the control group had received dim light or usual care. 4 of the studies examined the application of light therapy devices while 11 involved light therapy. Two of the studies were cross-designed. The study authors noted that, “These findings combined with its low side effects suggest the role of light therapy as a promising treatment for AD.”

Recently announced topline data from a phase 2a trial showed that treatment with IPL344, an investigational agent developed by Immunity Pharma, resulted in statistically significant change in disease progression among patients with ALS, with positive benefits in weight gain, respiration, and survival. Over a 36-week treatment period, patients on once-daily IPL344 demonstrated a mean sleep of decline on ALS Functional Rating Scale-Revised (ALSFRS-R) of –0.53, equating to a 48% slower disease progression (P = .028). After adjusting for disease state and rate-indicating covariates, the rate of progression improved even further, with a 64% slowing (P = .034). Notably, the therapy was well-tolerated for the study duration, with no major drug-related serious adverse events. The phase 1/2a open-label trial features 9 patients with probable or definite ALS who underwent a 28-day phase 1 dose-escalation portion, followed by an optional phase 2a portion.