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FDA Grants Permission to Enroll up to 8 Additional Secondary Progressive Multiple Sclerosis (SPMS) Patients in the Expanded Access Program with Intranasal Foralumab
This Intermediate-Size Patient Population Expanded Access program will follow the same clinical dosing regimen as the two ongoing single-patient expanded
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"This Intermediate-Size Patient Population Expanded Access program will follow the same clinical dosing regimen as the two ongoing single-patient expanded access programs in SPMS patients.Tiziana recently reported clinical data from the first SPMS patient showing beneficial responses following six months of treatment with intranasal foralumab, a fully human anti-CD3 monoclonal antibodyThe clinical data update from the second SPMS patient is expected in May 2022, representing 3 months of intranasal foralumab therapy. NEW YORK, April 05, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (Nasdaq: TLSA) (\"Tiziana\" or the \"Company\"), a biotechnology company enabling breakthrough immunotherapies via novel routes of monoclonal antibody delivery, today announced that its collaborators at the Brigham and Women’s Hospital (BWH) Boston MA have received a ‘Study May Proceed Letter’ from the U.S. Food and Drug Administration (FDA) permitting initiation of treatment in up to an additional eight SPMS patients as part of an Intermediate-Size Patient Population Expanded Access IND. The safety, tolerability, and clinical responses from the first two SPMS patients were submitted to the FDA to seek permission to treat up to an additional eight SPMS patients with the goal of obtaining more clinical data to assess robustness of the clinical responses. As part of the original treatment plan, the foralumab dose will remain 50 mcg three times a week (MWF), which is the same dose administered previously to the first two SPMS patients. The dosing regimen in this IND also has a provision for dose escalation up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed. The treatment plan will be submitted to the Institutional Review Board (IRB) of BWH prior to initiation of patient enrollment and initiation of the study, which is anticipated to be initiated in July 2022. While the primary objectives are safety, tolerability and patient benefits, additional measures will assess clinical and immune responses, including imaging by positron emission tomography (PET), specifically to assess inhibition of microglial activation. Excessive activation of microglial cells is well-known to be associated with neurodegenerative diseases such as multiple sclerosis (MS), Alzheimer’s disease and Parkinson1. The underlying causes of these disea...