fig7

Figure 7. Serum HNE levels were evaluated throughout the Phase 2 A trial. HNE was significantly elevated in the 2 ALS patients who progressed rapidly despite escalating doses of Treg/IL-2 infusions during the Open Label Extension (OLE). The down arrows indicate dates of infusions Patient 201 (Left) had received 12 monthly Treg/IL-2 infusions while patient 103 (Right) received 6 monthly infusions only during the OLE. Both patients progressed rapidly and both had markedly increased HNE. The 6 ALS patients whose progression appeared to have slowed during the OLE had HNE levels within the normal range averaging less than 10 μg/mL. The red line indicates the mean of healthy controls and the green lines ± 1 standard deviation. ALS: Amyotrophic lateral sclerosis; HNE: 4-hydroxynonenal.