Tiziana Life Sciences Inc. (NASDAQ: TLSA) stock declined by 2.54% at last close however the TLSA stock price depicts a rise of 8.26% during the pre-market trading session. Tiziana Life Sciences is a biotech business based in the United Kingdom that focuses on the research and development of new compounds to treat cancer and immunology in humans.
Tiziana Life Sciences has inked a deal to perform a Phase 2 Proof-of-Concept research in Brazil with FHI Clinical which is a worldwide clinical contract research organization (CRO). Its goal is to see if intranasal Foralumab is safe, tolerable, and effective in hospitalized patients with chronic coronavirus disease 2019 (COVID-19) and pulmonary inflammation.
Foralumab will be administered intranasally using a metered-dose nasal atomization device in this clinical study. Nasal administration of Foralumab is a cutting-edge treatment option for individuals with autoimmune disorders in whom the immune system has become deregulated. Numerous studies have shown that people with COVID-19 have immune system dysfunction.
This concrete evidence research will build on initial results of safety, tolerability, and effectiveness of intranasal administration of Foralumab in mild to severe non-hospitalized COVID-19 individuals. It will be randomized, placebo-controlled, and double-blind. As a result, this study will look at the attenuation of pulmonary pathology in hospitalized COVID-19 patients. This research will be placed at up to seven different locations across Brazil. The study will include 80 hospitalized patients with severe COVID-19 and evidence of lung involvement on a computed CT scan at screening.
Intranasal Foralumab 100 g will be given to patients in a 1:1 ratio. Following 14 days of intranasal treatment, the researchers will assess the efficacy of Foralumab on symptom alleviation by chest CT, inflammatory biomarkers, T-cell subpopulations, safety, and mucosal inflammatory response.
Ted FitzGerald, FHI Clinical President and CEO stated,
FHI is particularly qualified to meet the demands of this Phase 2 study because they can build on previous epidemic expertise, such as quick study start-up in research-naive areas, utilizing existing worldwide research networks, and contributing to local health systems. They’re experts in dealing with the complexities of infectious disease studies, which need meticulous preparation and contingency planning.