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Tiziana Life Sciences Ltd. develops intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a clinical-stage biotechnology company focused on neuroinflammatory and neurodegenerative diseases. News for TLSA centers on clinical and preclinical data for intranasal anti-CD3 therapy, including non-active secondary progressive multiple sclerosis, Multiple System Atrophy, Alzheimer’s disease, ALS, Long COVID-associated neuroinflammation, and age-related cognitive decline.
Company updates also cover biomarker work involving CSF proteomics, TSPO-PET and microglial activation, peer-reviewed publications, scientific conference presentations, expanded-access observations, and financing actions such as registered direct offerings of ordinary shares and warrants.
Tiziana Life Sciences (NASDAQ: TLSA) reported a 80% qualitative improvement in PET imaging for non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients receiving intranasal foralumab for at least six months. The FDA has permitted the enrollment of an additional 20 patients in the Expanded Access Program (EA), aiming to gather more data and analyze for further insights. The company also applied for FDA Orphan Drug Designation for foralumab to treat na-SPMS. This development is a significant milestone for Tiziana's immunomodulation therapies, as stated by Gabriele Cerrone, the acting CEO and founder.
Tiziana Life Sciences (Nasdaq: TLSA), a biotechnology company, has applied for a grant from the ALS Association to fund a clinical trial for intranasal foralumab, an anti-CD3 monoclonal antibody. The grant is part of the Hoffman ALS Clinical Trial Awards Program. The trial aims to evaluate the safety, dosing, and biomarkers of foralumab in ALS patients using cutting-edge imaging techniques like PET scans. Previously, foralumab showed promising results in an Expanded Access Program for non-active secondary progressive multiple sclerosis. The company hopes the grant will support a 6-month trial involving 20 participants, advancing their efforts to develop effective ALS treatments.
Tiziana Life Sciences announced that Dr. Howard L. Weiner, its Scientific Advisory Board Chairman, will receive the 'Giants of MS' award for his contributions to multiple sclerosis (MS) research.
The award will be presented at the Consortium of Multiple Sclerosis Centers annual meeting on May 30, 2024.
Dr. Weiner is celebrated for his work on innovative treatments like intranasal foralumab, which shows promise in improving the lives of MS patients.
Foralumab has shown positive results in an Expanded Access Program, with 70% of patients experiencing improved fatigue.
The drug is also undergoing a Phase 2a trial, with data expected in 2025.
Tiziana Life Sciences, a biotechnology company, files for Orphan Drug Designation for intranasal foralumab for treating non-active secondary progressive Multiple Sclerosis, aiming to be the first therapy to receive this designation. Supported by clinical evidence, the drug has shown positive results in an Expanded Access Program, improving fatigue in 70% of patients. A Phase 2a trial is ongoing, with a data readout expected in 2025. Orphan Drug Designation brings significant benefits if approved.
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