Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has been approved by the US Food and Drug Administration to expand patient enrollment in its non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access Program.
The company said it will expand the program, which is evaluating its investigative therapeutic intranasal foralumab, from 10 patients to 30.
To date, of the 10 patients already enrolled, two have been dosed for more than a year and eight have been dosed for six months, all without serious side effects, Tiziana said.
The company said all the patients have either stabilized or improved on treatment with foralumab, with 70% of patients seeing a measurable improvement in fatigue.
The Expanded Access Program allows patients to access an investigational drug to diagnose, monitor, or treat their condition rather than obtaining information about it that is usually gained from clinical trials.
Patients not eligible for a Phase 2a trial of foralumab in na-SPMS initiated by Tiziana in November 2023 can now be considered for this expanded program, the company said.
“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,” principal investigator Dr Tanuja Chitnis said.
“The Expanded Access 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.”
Tiziana CEO Gabriele Cerrone added: “Tiziana is glad to provide patients with na-SPMS who do not qualify to be enrolled on our Phase 2 trial 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 Expanded Access Program gives these patients access to this novel drug,” Cerrone said.