(Alliance News) - Tiziana Life Sciences PLC on Monday said the US Food & Drug Adminsitration has allowed the company to begin a phase 1 clinical trial of its novel Foralumab formulation in healthy volunteers.
Shares in Tiziana were down 6.9% at 60.50 pence in London at midday.
The trial will use a novel oral enteric-coated capsule formulation of Foralumab and qill be the first time the drug will be administered orally to healthy subjects. The goal of the drug is to treat autoimmune and inflammatory diseases.
Foralumab is being developed by Tiziana in collaboration with the Brigham & Women's Hospital at Boston's Harvard Medical School.
Howard Weiner, a professor at the Brigham & Women's Hospital, said: "The therapeutic approach of oral administration with Foralumab should greatly enhance our ability to treat neurodegenerative and inflammatory diseases. We have also explored the nasal administration of Foralumab for the treatment of progressive [multiple sclerosis]. We believe nasal and oral administration with Foralumab opens innovative avenues to treat inflammatory and autoimmune diseases by inducing different classes of [T regulatory cells]. Thus, mucosal activation stimulating Tregs is a physiological mechanism which we think might be safer than other treatment approaches."
Weiner discovered the scientific rationale behind this Foralumab formulation treatment.