Tiziana Life Sciences Aims to Fast-Track Multiple Sclerosis Treatment with FDA Submission
Tiziana Life Sciences (Nasdaq: TLSA) has received acceptance from the FDA of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS). The company is developing intranasal foralumab for the treatment of autoimmune and inflammatory diseases.
Foralumab dampens inflammation by modulating T cell function, and is the only fully human anti-CD3 monoclonal antibody (mAb). Tiziana is currently studying nasal foralumab in a Phase 2a, double-blind randomized, placebo-controlled, multicenter trial in patients with na-SPMS.
Commenting on the submission, Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, said “Fast track is designed to expedite the review of drugs in development to treat serious conditions for which there are limited or no therapies. The progressive nature of na-SPMS and lack of FDA-approved therapies for this disease aligns with the Food and Drug Administration’s criteria for Fast Track Designation. The increased interaction and partnership with the FDA afforded by this designation would be a tremendous asset to our foralumab development program, if granted.”
Multiple sclerosis affects approximately one million people in the US. There are no therapies currently approved for na-SPMS.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For more information, please visit our website: www.tizianalifesciences.com
