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Tiziana Life Sciences Secures FDA Authorization for In-Home Intranasal Foralumab Administration in Treating Multiple Sclerosis

Thursday, October 19, 2023

Tiziana Life Sciences Ltd. (Nasdaq: TLSA) has achieved a significant milestone in the treatment of multiple sclerosis. The U.S. Food and Drug Administration (FDA) has given approval for multiple sclerosis patients to self-administer Intranasal Foralumab, a pioneering treatment developed by the company. This development represents a substantial advancement in enhancing the accessibility and convenience of care for individuals living with multiple sclerosis.

Intranasal Foralumab is a novel biologic therapy that has shown significant potential in managing multiple sclerosis. Allowing patients to self-administer this treatment at home eliminates the need for frequent visits to healthcare facilities for treatment.

Tiziana Life Sciences, expressed his enthusiasm for the FDA's decision, emphasizing how it aligns with the company's mission to make innovative therapies more accessible and improve the quality of life for patients. This approach is expected to transform the way multiple sclerosis patients manage their condition.

Tiziana, noted that this change in dosing frequency will significantly reduce the burden on patients who previously had to visit clinics multiple times a week. The new dosing and evaluation schedule will also be adopted in the upcoming Phase 2a double-blind study starting in November.

Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital, expressed her support for this development, as it greatly eases the challenges faced by her patients with multiple sclerosis.

Foralumab, a fully human anti-CD3 monoclonal antibody, targets and modulates activated T cells to reduce inflammation, affecting multiple immune cell subsets. This has shown promise in patients with conditions like COVID and multiple sclerosis, as well as in healthy individuals. The non-active SPMS intranasal Foralumab Phase 2 trial is set to begin screening in November 2023. Using nasal anti-CD3 mAb for immunomodulation represents a novel approach to treating neuroinflammatory and neurodegenerative human diseases.

 

Source: globenewswire.com

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