Tiziana Life Sciences Announces FDA Allowance for Additional Twenty Patients to be Enrolled in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program

NEW YORK, April 23, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10 patients to a total of 30 patients.

To date, of the 10 participating patients, two patients have been dosed for more than one year and eight additional patients have been dosed for six months, all without serious side effects. All patients have either stabilized or improved on treatment with foralumab, and no patients have declined in key clinical measures. Additionally, 70% of these patients have seen a measurable improvement in fatigue. These data are the first to combine PET imaging with a novel ligand, immune-biomarkers, clinical measures and comprehensive safety data endpoints in patients receiving long-term intranasal foralumab. In November 2023 Tiziana initiated a Phase 2a trial in na-SPMS. Patients not eligible for the Phase 2a trial may now be considered for this expanded EA program.

The September 2023 release of FDA guidance entitled “Guidance on Substantial and Confirmatory Evidence of Efficacy and Safety” addresses the use of EA programs to be considered as part of confirmatory evidence. As per FDA guidance, “Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition rather than to obtain the kind of information about the drug that is generally derived from clinical trials.”

Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “Tiziana is glad to provide patients with na-SPMS who do not qualify to be enrolled on our Phase 2 trial (NCT06292923) the possibility to receive open-label treatment with our intranasal fully human anti-CD3 monoclonal-antibody, foralumab. As there are no FDA approved treatments for na-SPMS, an EA program gives these patients access to this novel drug.”

“I am grateful to be allowed to dose 20 additional patients that do not meet the inclusion criteria for the ongoing intranasal foralumab Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study multiple sclerosis trial potential access to this treatment,” stated Dr. Tanuja Chitnis, M.D., Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System. “The EA program has allowed us to obtain important information about dosing, and drug use, including patient feedback which was critical for the design of the current Phase 2a trial.”