Tiziana Life Sciences plc (TLSA), a biotechnology company specializing in innovative therapeutics for inflammatory disorders and cancers, announced an update on further assessment of lymphocyte subsets from blood samples from a Phase 1 study with nasally administered Foralumab in healthy subjects. TLSA stock price increased adjacent to the news.
Tiziana Life Sciences PLC (TLSA) shares were rising 4.17% to trade at $2.50 in the premarket. TLSA’s stock gained 3.90% to close Tuesday’s session at $2.40. Shares of the company fluctuated between $2.32 and $2.49 throughout the day. TLSA shares have fallen by -3.07% over the last 12 months, and they have moved up by 7.14% in the past week.
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Clinical Data Highlights
Nasally administered Foralumab had high tolerance and no symptoms regarding severe toxicity or cytokine release syndrome were seen. Systemic levels of Foralumab were lower than the quantitation limit of 8 ng/mL depicting that nasally administered Foralumabmay exert adequate effects through nasal epithelium utilizing local and lymphatic immune systems directly.
Most distinguished effect was seen across cytotoxic T-cell subsets which were assessed in the 50mcg group in comparison to 10mcg, 250mcg, and placebo groups.
The observed effects in the 50mcg dose group were inclusive of:
Essential reductions through analysis from baseline in CD8_Tem cytotoxic T-cell subset through two weeks and CD8_TEMRA, CD8_GranzymeB, CD8_Perforin subsets through three weeks.
Qualitative significant increment from baseline in CD8_naive subset through day 21
High stimulation in the generation of anti-inflammatory cytokine IL-10 along with the suppressed generation of pro-inflammatory cytokine IFN-γ, represented a positive trend for immunomodulation and anti-inflammatory effect.
The assessment of the responses on biomarkers represent that immunomodulation and anti-inflammatory, are compatible with the positive top-line data shown by nasally administered Foralumab in COVID-19 patients in Brazil. Results from this clinical study represented that nasally administered Foralumab at 100 mcg per day for 10 consecutive days was well-tolerated and depicted a high reduction of lung inflammation.
Conclusion
TLSA produced positive top-line clinical data for reduction in lung inflammation. Furthermore, Positive statistical analysis for the 50 mcg dose group represented significant treatment for inflammatory diseases. TLSA stock price increased significantly at pre-market.