Tiziana Life Sciences Announces Near-Term Strategic Focus on Intranasal Foralumab for Diseases of the Central Nervous System (CNS)
To date, Tiziana’s fully human anti-CD3 monoclonal antibody, foralumab, administered intranasally through Tiziana’s proprietary drug delivery technology, has shown benefit in several different pre-clinical models of CNS-based inflammatory disease. These studies confirmed the uptake of the drug in the cervical lymph nodes of these animal models – an area rich in lymphocytes that is a key site of action to target since it then spurs the production of T-cells and reduces inflammation.
MS program updates:
Tiziana expects to announce the result of the six-month PET scan on patient EA2 and the nine-month PET scan on patient EA1 also in the first quarter of 2023. Additionally, Tiziana recently announced the completion of enrollment for the first cohort of its intermediate-size patient population (four patients) to continue to evaluate the safety and activity of intranasal foralumab in non-active SPMS patients, as part of its Expanded Access Program (EAP). During the first quarter of 2023, the Company then plans to perform three-month PET scans on patients EA3 through EA6 anticipating the results to be available in Q2 2023.
Separately, in the fourth quarter of 2022, Tiziana expects to request a “Type C” meeting with FDA to discuss its Phase 2 program for evaluating foralumab in non-active SPMS patients and receive feedback from FDA by the end of the first quarter of 2023.
Conference Call Webcast Information
Please register to listen to the conference call via webcast at the following link:
After registering, participants will be able to ask management text-based questions.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough immunomodulation therapies using transformational drug delivery technologies with a focus on its lead candidate, intranasal foralumab, as a treatment for diseases of the central nervous system (CNS). Tiziana’s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s intranasal foralumab is the only fully human anti-CD3 mAb and has 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 allow for broad pipeline applications.
For further inquiries:
+44 (0) 207 495 2379
Source: Tiziana Life Sciences Ltd.