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Tiziana Life Sciences Ltd. (NASDAQ: TLSA) is a progressive clinical-stage biotechnology company committed to developing transformative therapies targeting neurodegenerative and lung diseases. The company leverages innovative drug-delivery technologies to create novel treatments aimed at improving patient outcomes.
Key to Tiziana's portfolio are two prominent compounds: Milciclib and Foralumab. Milciclib, an inhibitor of cyclin-dependent kinases, is in Phase II clinical trials for thymic carcinoma, aiming to provide new hope for patients who have exhausted chemotherapy options. Foralumab, noted for being the only fully human-engineered anti-CD3 monoclonal antibody, is in various stages of clinical development for multiple sclerosis, autoimmune, and inflammatory diseases.
In a significant advancement, Tiziana recently reported positive clinical outcomes from its Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS). Intranasal administration of Foralumab led to remarkable improvement in fatigue symptoms in 70% of patients over six months, as measured by the Modified Fatigue Impact Scale (MFIS). These results signify a groundbreaking step in addressing an unmet need in MS treatment.
The company's commitment to innovation is backed by strategic partnerships with prestigious institutions like Harvard Medical School and Brigham and Women's Hospital. Tiziana’s leadership team brings extensive experience in drug development and commercialization, ensuring a firm trajectory toward regulatory approvals and market entry.
Moreover, Tiziana’s pipeline includes potential therapies for conditions like ALS, Alzheimer's, and Crohn's Disease, underscoring its dedication to tackling a broad spectrum of debilitating conditions. The company’s forward-looking approach aims to revolutionize treatment paradigms through enhanced drug delivery systems that promise increased efficacy and reduced side effects.
With a robust clinical pipeline, strategic collaborations, and innovative technologies, Tiziana Life Sciences Ltd. remains at the forefront of biopharmaceutical research, poised to make significant strides in the field of immunomodulation therapies.
Tiziana Life Sciences Ltd. (TLSA) announced plans to submit an IND for intranasal foralumab in Alzheimer’s patients during Q2 2023, following FDA Type “B” meeting feedback. The company seeks $3M in non-dilutive funding from an Alzheimer’s foundation to support a Phase 2a trial aimed at assessing the drug’s effects on neuroinflammation related to microglia activation.
The study aims to administer intranasal foralumab over three months to evaluate its potential in restoring the neuroinflammatory activated state of microglia in Alzheimer’s patients. There are currently no approved treatments for neuroinflammation specifically triggered by amyloid beta plaque.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced the initiation of a program to develop its intranasal foralumab, a fully human CD3 antibody, for treating or preventing Type 1 Diabetes. Following the $2.9 billion acquisition of Provention Bio by Sanofi, CD3 antibodies have become an attractive target in diabetes treatments. Foralumab’s unique delivery method aims to provide a non-injection alternative that might enhance patient compliance. The company plans to commence Phase 2 trials in non-active Secondary Progressive Multiple Sclerosis (SPMS) in the third quarter of 2023. The ongoing discussions with diabetes experts will refine the study designs for foralumab, which has previously shown promise in various chronic diseases and patient safety.
Tiziana Life Sciences (NASDAQ: TLSA) is developing foralumab, the first fully human anti-CD3 monoclonal antibody aimed at treating late-stage Multiple Sclerosis (MS). This innovative treatment functions through a nasal spray and modulates the immune system, specifically targeting regulatory T-cells to reduce brain inflammation. Recent research published in Proceedings of the National Academy of Sciences highlighted foralumab's efficacy in lowering inflammation in both COVID-19 and MS patients. Initial results from an open-label program showed promising outcomes for a patient previously on ocrelizumab, with his Expanded Disability Status Scale (EDSS) score improving significantly. Encouraged by these findings, Tiziana plans to initiate a Phase 2 trial in Q3 2023, focusing on long-term efficacy and safety of foralumab in MS treatment.
Tiziana Life Sciences (Nasdaq: TLSA) announced plans to investigate intranasal foralumab as a potential treatment for Long COVID, a condition affecting over 9 million Americans and costing the U.S. healthcare system approximately $2.6 trillion. The company emphasizes foralumab's role in deactivating activated microglia, critical in Long COVID's pathogenesis. Tiziana aims to enter a Phase 2a clinical trial pending FDA approval, using PET scans to assess the medication's effectiveness in reducing activated microglia after three months of use. The company believes that foralumab could represent a novel treatment for this debilitating condition, potentially benefiting a large patient population and addressing a significant unmet medical need.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced poster presentations on its lead asset, intranasal foralumab, at the "Preserving the Brain" scientific conference in Shanghai, running from March 31 to May 21, 2023. The event aims to foster discussions on neurodegenerative diseases among international experts. Gabriele Cerrone, Executive Chairman of Tiziana, expressed enthusiasm for foralumab's presentation, highlighting it as the only fully human anti-CD3 monoclonal antibody. Foralumab modulates T cell function which may aid in treating inflammatory conditions. Phase 2 trials for intranasal foralumab in patients with non-active SPMS are anticipated to begin in Q3 2023.
Tiziana Life Sciences (TLSA) announced promising findings related to the treatment of hemorrhagic stroke using intranasal anti-CD3 monoclonal antibodies. Dr. Saef Izzy's data indicates significant behavioral improvement in an animal model within one month post-treatment, supported by modulation of neuroinflammation through FoxP3+ Tregs. The research will be presented at the Annual American Academy of Neurology conference on April 23, 2023. The company aims to advance the clinical development of foralumab, the only fully human anti-CD3 monoclonal antibody, potentially transforming therapy for hemorrhagic stroke and improving neurological recovery outcomes.
Tiziana Life Sciences (TLSA) has announced plans to advance foralumab, a fully human anti-CD3 monoclonal antibody, into human trials targeting hemorrhagic stroke. Recent pre-clinical data indicates significant behavioral improvement in motor and cognitive functions one month after treatment in a model of intracerebral hemorrhage. The mechanism involves modulation of neuroinflammation through the induction of FoxP3+ Tregs, which may lead to enhanced recovery in stroke patients. Tiziana is actively pursuing clinical development, with Phase 2 trials of intranasal foralumab anticipated to initiate in Q3 2023.
Tiziana Life Sciences (NASDAQ: TLSA) announced promising results from a study on intranasal anti-CD3 monoclonal antibody for Alzheimer’s disease, to be presented at the AD/PD 2023 Conference on April 1, 2023. The study indicates reduced microglia activation and improved behavior in rodent models, suggesting that targeting neuroinflammation may enhance existing Alzheimer’s treatments. Dr. Howard Weiner highlighted that the research could complement FDA-approved therapies like aducanumab and lecanemab. Tiziana plans to initiate Phase 2 trials with foralumab in the third quarter of 2023, focusing on its immunomodulatory effects.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced that its Chairman and Acting CEO, Gabriele Cerrone, acquired 8,000 common shares at $0.89 each, raising his total holdings to 38,701,237 shares. The company specializes in breakthrough immunotherapies with innovative drug delivery methods. Its lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody, showing potential in treating inflammatory diseases and demonstrating a favorable safety profile in initial studies. Phase 2 trials for foralumab are scheduled to begin in Q3 2023 for patients with non-active secondary progressive multiple sclerosis (SPMS).
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