Tiziana Life Sciences has announced that the FDA approved the company’s IND for intranasal foralumab human anti-CD3 antibody, and a Phase 1 clinical trial has begun. Tiziana licensed foralumab from Novimmune in 2014 and is developing the nasal formulation for the treatment of neurodegenerative diseases such as multiple sclerosis.
The dose escalating trial, conducted at Brigham and Women’s Hospital by Howard Weiner of Harvard Medical School, will evaluate immunomodulation biomarkers for 10, 50, and 250 µg/day of foralumab delivered via nasal spray.
Tiziana Chairman and founder Gabriele Cerrone commented, “Intranasal delivery of therapeutic anti-CD3 mAb is a game changer that employs immune mechanisms overcoming the obstacle of the blood brain barrier and it has the potential as entirely new class of therapies for treatment of a wide range of human diseases. Filing this IND for nasal administration of foralumab is a first and major milestone towards the company’s objective to develop innovative therapies with alternative routes of administration whilst maximizing efficacy.”
Read the Tiziana press release.
