RNS OUT2 Nov 2020 07:02
Tiziana Life Sciences PLC
("Tiziana" or "the Company")
Tiziana Announces Initiation of Clinical Trial for COVID-19 Patients in Brazil with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody
London/New York, 2 November 2020 - 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 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 INTRIALS, a leading, full-service Latin America Clinical Research Organisation, (CRO) based in Sao Paulo City, Brazil. The clinical data from this trial is expected to be available by the end of this year.
Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences stated:
· "Brazil has reported almost 5.5 million Coronavirus cases and 159,000 deaths and is considered a global epicenter of the outbreak. Brazil is currently experiencing almost 1,000 deaths per day. Therefore, our clinical study is both timely and a potential life changer for COVID-19 patients. The scientific concept, through activation of nasal mucosal immunity via nasally administered Foralumab, aims to fight the virus in the respiratory tract and lungs". The clinical study will start dosing patients on 3 November 2020 with data expected to be available before the end of 2020
· Since reduced or defective levels of T regulatory (Tregs) cells in the blood seem to be associated with the severity of COVID-19 and acute respiratory distress syndrome (ARDS), nasally administered Foralumab, by acting locally, could potentially suppress a 'cytokine storm' and hyperinflammation in the respiratory tract and lungs of COVID-19 patients
· A patent application was filed in July 2020 to protect the potential use of nasally administered Foralumab for the treatment of COVID-19 either alone or in combination with other anti-viral drugs.
Dr Howard Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital, and a Scientific Advisor to the Company, commented: "Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems. Results from studies, conducted in our laboratory have established that nasal ad