Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced the start of enrollment of the first patient cohort in its intermediate-size patient population expanded access program to evaluate foralumab in non-active Secondary Progressive Multiple Sclerosis (SPMS) patients.
This treatment program will evaluate dosing at the "standard" dosing of 50 mcg and, if needed, a higher 100 mcg dose of intranasal foralumab in two separate cohorts of four non-active SPMS patients each, Tiziana said.
The program is being conducted at Brigham and Women's Hospital in Boston, Massachusetts.
"In addition to this exciting news about starting this new treatment program in non-active SPMS, we are pleased to report that we are on track to conduct PET scans on our first two patients from our original study in the upcoming months," said Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana in a statement.
READ: Tiziana Life Sciences plans to submit IND for phase 1 trial of intranasal foralumab in Alzheimer's disease patients by Q3 2023
"These data will be vital to confirming the durable clinical benefits of intranasal foralumab and will support our efforts to begin our Phase 2 study of foralumab in SPMS patients in mid-to-late 2023," he added.
Dr Tanuja Chitnis, professor of neurology and senior neurologist in the Ann Romney Center for Neurologic Diseases, Brigham & Women's Hospital and a member of Tiziana's Scientific Advisory Board, commented: "We are looking forward to fully enrolling this important new treatment program. It will be the first time that non-active Secondary Progressive Multiple Sclerosis patients may receive higher, 100 mcg dosing of intranasal foralumab. To date, we have only studied 50 mcg dosing in patients with non-active SPMS.
“Given the strong feedback we've received relative to evaluating foralumab in the non-active Secondary Progressive Multiple Sclerosis patient population, I am anticipating swift enrollment of our first patient cohort."
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough immunomodulation therapies via novel routes of drug delivery.
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