Tiziana Life Sciences Ltd (NASDAQ:TLSA) has unveiled encouraing results from patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) enrolled in its Expanded Access Program who have been receiving its drug asset foralumab for at least six months.
The company is developing foralumab, the only fully human anti-CD3 mAb, which has demonstrated a favorable safety profile and clinical response in patients in studies to date.
It said that the latest data from its Expanded Access cohort when taken with earlier results showed qualitative improvements in PET imaging in 80% of patients receiving intranasal foralumab for at least six months.
Researcher Dr Tarun Singhal, director of the PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital and associate professor of neurology at Harvard Medical School, noted that further studies are needed to confirm these findings using additional cases and quantitative approaches.
The Food and Drug Administration (FDA)’s Allowance enables the enrollment of an additional 20 patients in the Expanded Access program, which will allow for further data collection and analysis.
“I am thrilled that 80% of the na-SPMS patients who received intranasal foralumab treatment for at least six months have a qualitative reduction of microglial activity as confirmed in these latest PET images,” Tiziana acting CEO and chairman Gabriele Cerrone commented.
“I am also greatly appreciative of Dr Singhal’s research and look forward to the additional quantitative analysis of the data. With the allowance of an additional 20 patients in the Expanded Access program, the application for Orphan Drug Designation for na-SPMS, and the ongoing Phase 2a trial, Tiziana is rapidly progressing its intranasal foralumab program in multiple sclerosis.”