The patent will be published by the USPTO on 1 September, 2020 as Patent No. 10,759,858.
Tiziana previously reported the successful completion of a Phase 1 trial utilizing oral administration of Foralumab on 1/92020, which was designed to evaluate its safety and tolerability in healthy subjects. The trial was conducted at Brigham and Women’s Hospital, Harvard Medical School, Boston, Mass., and indicated that oral administration of Foralumab was well-tolerated up to a 5 mg dose. The Company plans to move forward with a phase 2 trial in 4Q-2020 with orally administered Foralumab for the evaluation of moderate-to-severe patients with Crohn’s Disease.
Additionally, Tiziana previously reported the successful completion of a Phase 1 study evaluating safety and analysis of biomarkers for clinical activity of nasally administered stabilized solution of Foralumab on 28 November 2018.
Additionally, a Phase 2 trial in patients with progressive multiple sclerosis will commence in the 4th quarter. Importantly, in both clinical studies, the severe toxicities commonly associated with intravenous administration of anti-CD3 mAbs were not observed with oral or nasal administration of Foralumab.
Recently, Tiziana also announced the issuance of the first-ever patent on oral administration of anti-CD3 mAbs for treatment of human diseases (Patent No. 10,688,186). The grant of this additional composition-of-matter and use patent further strengthens the Company’s intellectual property, consisting of proprietary technologies on oral and nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.