NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) — Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing innovative immunomodulation therapies through new routes administration, today announced the initiation of enrollment of the first patient cohort (n=4) in its Intermediate-Sized Patient Population Expanded Access Program to evaluate foralumab in non-active patients with Secondary Progressive Multiple Sclerosis (SPMS). ). This treatment program will evaluate dosing at the “standard” dose of 50 mcg and, if necessary, a higher dose of 100 mcg intranasal foralumab in two separate cohorts of four patients with non-active SPMS each. The program is held at Brigham and Women’s Hospital in Boston, Massachusetts.
“In addition to this exciting news about the initiation of this new treatment program in non-active SPMS, we are pleased to report that we are on track to perform PET scans on the first two patients in our original study in the coming months,” said Gabriele. Cerrone, Executive Chairman and Interim CEO of Tiziana. “These data will be vital in confirming the long-lasting 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.”
Dr. Tanuja Chitnis, MD, Professor of Neurology and Senior Neurologist at the Ann Romney Center for Neurological Diseases, Brigham & Women’s Hospital and a member of the Tiziana Scientific Advisory Board, added, “We look forward to fully enrolling this important new treatment program . . It will be the first time that non-active patients with secondary progressive multiple sclerosis can receive a dose greater than 100 mcg of intranasal foralumab. To date, we have only studied the 50 mcg dose in patients with non-active SPMS. Given the strong feedback we have received regarding the evaluation of foralumab in the non-active secondary progressive multiple sclerosis patient population, I am anticipating rapid enrollment of our first patient cohort.”
Foralumab (formerly NI-0401), the only fully human anti-CD3 mAb, shows reduced cytokine release after IV administration in healthy volunteers and in patients with Crohn’s disease. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates T cell immune responses and enhances regulatory T cells (Tregs). ), thus providing therapeutic benefit in the treatment of inflammatory and autoimmune diseases without the occurrence of potential adverse events normally associated with parenteral mAb therapy. Once daily treatment for 10 consecutive days with intranasal foralumab was well tolerated and produced clinical responses in patients with COVID-19. Based on these studies, intranasal and oral administration of foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by inducing Tregs.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing innovative immunomodulation therapies through new routes of drug delivery. Tiziana’s innovative nasal, oral, and inhalation approaches in development have the potential to provide improved efficacy, as well as safety and tolerability compared to intravenous (IV) administration. Tiziana’s two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have 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 enable a broad portfolio of applications.
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