The trial will see the Tiziana drug administered either alone or in combination with dexamethasone, a corticosteroid medication. Clinical data are expected by the end of this year.
The company said it is working closely with the collaboration partners, the Harvard Medical School and Santa Casa de Misericórdia de Santos Hospital in Santos, Brazil, to ensure the process is quickly “expedited”.
The day-to-day work will be coordinated by the team at the INTRIALS, a clinical research organization based in Sao Paulo.
Brazil has reported around 5.5mln coronavirus cases and 159,000 deaths in total running at almost 1,000 a day, Tiziana pointed out.
“Thus, our clinical study is both timely and potentially a life changer for the COVID-19 patients,” said Dr Kunwar Shailubhai, the company’s chief executive in a statement. “The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the virus in the respiratory tract and lungs.”
Foralumab, a fully human anti-CD3 monoclonal antibody, is being deployed to suppress an overreaction of the immune system called a cytokine storm that occurs in those worst-affected by the virus.
In doing so it is hoped it will reduce respiratory failure, the main underlying cause of COVID-19 deaths.
Meanwhile, the nasal administration of Foralumab to modulate the human immune system is seen as a potentially transformational approach for treating patients, not just with COVID-19 but a variety of human diseases with dysregulated immune systems.
“Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs [regulatory T cells] that can suppress inflammation and ameliorate diseases in animal models,” said Dr Howard Weiner, a world-leading neurologist based at Harvard and chairman of Tiziana’s scientific advisory board.
“Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease," he added.
A patent for this potentially revolutionary nasally administered delivery system has already been filed.