Tiziana reports data indicating significant immunomodulation effects on immune and inflammatory biomarkers with nasally administered foralumab in healthy volunteers
New york and london, may 26, 2021 (globe newswire) -- tiziana life sciences plc (nasdaq: tlsa, lse: tils) (“tiziana” or the “company”), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, today provided an update on further analysis of lymphocyte subsets from blood samples from a phase 1 study with nasally administered foralumab in healthy volunteers. results exhibiting statistically significant immunomodulatory effects on cd8 cytotoxic t-lymphocytes and other inflammatory biomarkers were observed. this phase 1 trial, conducted at the brigham and women's hospital, harvard medical school, boston, ma, was a single-site, double-blind, placebo-controlled, dose-ranging study with nasally administered foralumab at 10, 50 and 250 mcg per day, consecutively for 5 days in healthy volunteers. the treatment was well-tolerated at all doses and there were no apparent symptoms of severe toxicity. importantly, the treatment showed significant positive effects at 50 mcg/day dose (compared to other dose and placebo groups) on t-cell subsets and inflammatory biomarkers. these data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted immunomodulation and anti-inflammatory effects. furthermore these pharmacodynamic data point to a clinical dose range that tiziana intends to test in further clinical development among ms patients.
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