This is a huge milestone for the company as we have brought the time-line forward by a year
Chairman Gabriele Cerrone
Tiziana Life Sciences PLC (NASDAQ:TLSA, LON:TILS) has signed an agreement to use its “potentially transformative” approach to modulating the immune system in a human clinical study of patients with coronavirus (COVID-19).
Work will get underway in Brazil starting next month, with the company's drug, Foralumab, administered by nasal spray either on its own or in combination with an orally-taken anti-inflammatory called dexamethasone.
Tiziana has moved straight into human trials because it had already secured safety data for the nasal application for the drug from a phase I clinical assessment carried out a year ago.
"This is a huge milestone for the company as we have brought the time-line forward by getting it [the drug] into patients one year ahead of schedule," chairman Gabriele Cerrone said in an interview with Proactive's Andrew Scott, carried below.
The 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.
The drug developer, which on Wednesday formalised plans to demerge its diagnostics business, said the clinical study will start in the next few weeks with data anticipated before the end of the year.
It pointed out that it has developed a “robust formulation” for the delivery of Foralumab using a nasal spray.
There were also early signs from its phase I trial that the Tiziana drug and delivery system stimulated regulatory T-cells, or Tregs, that help control other cells in the immune system.
“Nasal administration of Foralumab to modulate human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune system,” said Dr Howard Weiner, a world-leading neurologist and chairman of Tiziana’s scientific advisory board in a statement.
“Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs that suppress inflammation and ameliorate diseases in animal models.”
The shares were up 8.7% at 160p in early afternoon trade.
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