Tiziana Life Sciences, a biotechnology company, announced initiation of a collaborative clinical study investigating nasally administered Foralumab either alone or in combination with orally administered dexamethasone in COVID-19 patients in Brazil. In view of the importance and urgency, scientific teams at the Harvard Medical School, Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) and at Tiziana are closely collaborating to facilitate initiation of this study in expedited time frames. This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. The clinical data from this trial is expected to available by the end of this year.
“Brazil has reported almost 5.5 million Coronavius cases and 159,000 deaths and is considered a global epicenter of the outbreak. Brazil is now experiencing almost 1000 deaths per day. Thus, our clinical study is both timely and potentially a life changer for the COVID-19 patients. The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the virus in the respiratory tract and lungs,” stated Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.
Dr. Rogério Dedivitis, the Clinical director of Santa Casa de Santos, stated: “The Santa Casa hospital, the first hospital founded in Brazil almost 500 years ago, is very pleased to be involved in such an important international clinical study. We are excited and confident that this study will contribute to the better understanding of COVID-19 disease, and importantly also benefit our patients.”
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn’s disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2?c-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.
