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Tiziana Life Sciences plc to Conduct a Clinical Study with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, for Treatment of COVID-19 Patients in Brazil
Nasal Administration of Foralumab is a potentially transformative approach for treating patients with Covid-19 NEW YORK and LONDON, Sept. 17, 2020 (GLOBE
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"Nasal Administration of Foralumab is a potentially transformative approach for treating patients with Covid-19 NEW YORK and LONDON, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that it has signed an agreement for a collaborative clinical study investigating nasally administered Foralumab in COVID-19 patients in Brazil, either alone or in combination with orally administered dexamethasone. The Company announced on July 31, 2020 its filing of a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), for the treatment of COVID-19 either alone or in combination with other anti-viral drugs. Clinical study anticipated to start in the next few weeks with clinical data potentially available before the end of 2020Scientific rationale for use of Foralumab as a treatment for COVID-19 patients is to help modulate the human immune system to suppress a possible “Cytokine storm” and to potentially reduce respiratory failure in COVID-19 patients The “Cytokine storm” (aka cytokine release syndrome) and hyperinflammation resulting in severe lung damage, followed by respiratory failure are the main underlying reasons for morbidity and mortality in COVID-19 patients (1). Recent clinical evidence suggests that the level of peripheral T regulatory cells (Tregs) is prominently reduced in severely ill COVID-19 patients (2), which could be one of the reasons for the hyperactivated immune system and damaged lungs in these patients. Since the reduction in Tregs and activation of the immune system are commonly observed in patients with Middle Eastern Middle Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS-CoV-1), COVID-19 and Acute Respiratory Distress Syndrome (ARDS), we believe that stimulation of Tregs is a highly innovative approach for the treatment of patients with these diseases. The Company has developed a robust formulation for delivery of Foralumab using a nasal spray device and has successfully completed a Phase 1 clinical trial demonstrating that the treatment was well-tolerated up to 250 microg/day and that it stimulated Tregs (https://www.tizianalifesciences.com/n...