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) has received FDA approval for its Phase 2a Investigational New Drug (IND) application to study intranasal foralumab in Multiple System Atrophy (MSA) patients. The six-month, open-label clinical trial will evaluate foralumab, a fully human anti-CD3 monoclonal antibody, for its effects on microglial activation, clinical outcomes, and safety.
MSA is a rare, rapidly progressive neurodegenerative disorder with no FDA-approved treatments. The disease affects 1.9-4.9 per 100,000 people worldwide, with a median survival of 6-9 years. The trial (NCT06868628) will administer foralumab via nasal spray in eight 3-week dosing cycles, targeting T-cell mediated neuroinflammation.
Tiziana Life Sciences (NASDAQ:TLSA) has reported promising immunologic findings from treating a moderate Alzheimer's Disease patient with intranasal foralumab, their lead immunomodulation therapy. The analysis revealed significant immune modulatory effects in white blood cells, including changes in CD4 cells, CD8 cells, and monocytes.
Key findings include a marked reduction in brain inflammation confirmed by microglia PET scans and an unexpected increase in phagocytosis markers in classical monocytes, suggesting potential for enhanced amyloid plaque clearance. The treatment was well-tolerated with no side effects, and the patient will continue therapy for an additional 6 months.
Tiziana Life Sciences (NASDAQ: TLSA) has showcased promising developments in their intranasal foralumab treatment for moderate Alzheimer's disease through a national radio interview. The treatment, a fully human anti-CD3 monoclonal antibody administered as a nasal spray, targets brain inflammation associated with Alzheimer's progression. Dr. Howard Weiner highlighted remarkable results from the first patient, Joe Walsh, at Brigham and Women's Hospital in Boston. According to Walsh's wife Karen, the treatment has led to noticeable improvements in his social engagement and overall condition. The case represents an encouraging advancement in Alzheimer's treatment, particularly in addressing brain inflammation as a key factor in disease progression.
Tiziana Life Sciences (NASDAQ: TLSA) announced that Executive Chairman and Founder Gabriele Cerrone has increased his stake in the company through the purchase of 15,000 common shares at $1.55 per share. Following this transaction, Cerrone's total holdings have reached 43,252,143 common shares, representing 37.02% of the company's issued share capital. Tiziana is developing immunomodulation therapies, with its lead candidate being intranasal foralumab, a fully human anti-CD3 monoclonal antibody.
Tiziana Life Sciences (NASDAQ: TLSA) has announced positive results from a clinical study of nasal foralumab in treating non-active secondary progressive multiple sclerosis (na-SPMS). The study involved 10 patients who were treated for a minimum of six months, with key findings including:
- No serious treatment-related adverse events reported
- Stabilization of Expanded Disability Status Scale (EDSS) scores in all patients
- Improvement in fatigue symptoms in 6 out of 10 patients
- Significant reductions in microglial activation at six months (p0.05)
- Increased regulatory T cells and TGFβ expression
The company has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial with expected top-line data by the end of 2025. The treatment represents a novel approach for na-SPMS patients who currently have limited treatment options.
Tiziana Life Sciences (Nasdaq: TLSA) has announced the commencement of dosing at the University of Massachusetts, the fourth clinical site in its ongoing Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS). UMass joins Brigham and Women's Hospital, Yale Multiple Sclerosis Center, and Johns Hopkins University in the study.
The blinded, placebo-controlled trial is expected to conclude by end-2025, followed by a six-month open-label extension phase where all participants can receive the treatment. Foralumab, the first fully human anti-CD3 monoclonal antibody administered intranasally, is designed to engage regulatory T cells and promote immune tolerance while minimizing systemic immune suppression.
The intranasal administration allows for at-home dosing, potentially improving compliance compared to intravenous treatments, particularly beneficial for patients dealing with fatigue.