Tiziana announces completion of the clinical trial with nasally administered Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19 patients in Bra
New York/London, 4 January 2021 - 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 the completion of its clinical study in Brazil investigating nasally administered Foralumab, its proprietary human monoclonal antibody, either alone or in combination with orally administered dexamethasone in COVID-19 patients.
The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Miseric?rdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in S?o Paulo, Brazil. The last patients in the trial received their final dose on 21 December 2020.
The topline data from the trial is expected to be available in January 2021.
Because COVID-19 enters through the nasal and respiratory passage, the proprietary nasal formulation and nasal delivery of Foralumab is an innovative approach to provide immediate relief to COVID-19 patients.
Dr. Howard Weiner (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) 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. Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients.?
Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated:
?We are delighted to receive positive feedback from patients treated in the clinical trial. Among the positive results patients reported, the most common was that the treatment resulted in the rapid improvement in smell sensation, which is frequently lost in COVID-19 patients.?
Dr. Kimble Matos, the lead coordinating physician of the study, commented:
?The observations made during the Clinical study did not show any adverse events.?
The clinical study enrolled a total of 39 patients with moderate to severe COVID-19 who did not require the use of a ventilator at the beginning of the study. This study had three cohorts: control (n=16), nasally administered Foralumab (n=12), and nasally administered Foralumab with 3 days of priming with orally administered 6 mg dexamethasone (n=11).
- The primary endpoint of this study was safety of the treatment, and secondary endpoints were to evaluate the effect of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression. The pharmacokinetics of nasally administered Foralumab will also be evaluated.
- Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected.
Tiziana Life Sciences plc Gabriele Cerrone, Chairman and founder | +44 (0)20 7495 2379 |
United States: Investors: Dave Gentry, CEO RedChip Companies Inc. 407-491-4498 dave@redchip.com |