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Tiziana Life Sciences Ltd. Common Shares - TLSA STOCK NEWS

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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.

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Tiziana Life Sciences (Nasdaq: TLSA) announced that the FDA has accepted its submission for Fast Track Designation for its intranasal foralumab treatment for non-active, secondary-progressive multiple sclerosis (na-SPMS). Foralumab is a fully human anti-CD3 monoclonal antibody designed to induce T regulatory cells. In an Intermediate-Sized Patient Population Expanded Access program, 70% of the ten dosed patients demonstrated a clinically meaningful reduction in fatigue, with disease stability observed over six months. The Fast Track submission included data from both animal models and clinical experience. If granted, this designation could expedite FDA review processes, which is significant given the lack of approved therapies for na-SPMS. Chairman and acting CEO Gabriele Cerrone highlighted the potential of Fast Track Designation to enhance development through increased FDA interaction and partnership.

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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.

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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.

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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.

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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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Tiziana Life Sciences reports positive 3-month neuroimaging scores in multiple sclerosis patients receiving intranasal foralumab. The company announced quantitative data showing improvement in White Matter Z-scores in patients with non-active secondary progressive multiple sclerosis. Dr. Tarun Singhal presented data demonstrating a reduction in microglial activation, indicating a positive effect on brain inflammation. A peer-reviewed journal has published the research findings. Tiziana is currently conducting a double-blind, placebo-controlled study to further evaluate intranasal foralumab's impact.
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Tiziana Life Sciences announces FDA allowance for additional patients in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program, with positive clinical data showing improvements in patients' conditions without serious side effects.
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Tiziana Life Sciences announced additional positive clinical results from its Expanded Access Program for non-active secondary progressive multiple sclerosis patients, with 70% showing improvement in fatigue after six months of follow-up. All patients stabilized or improved on nasal foralumab treatment. The findings highlight the potential of Tiziana's therapy to address the critical unmet need for individuals living with MS.
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Tiziana Life Sciences announced study results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA highlighted in Neurology Today®. The study shows that foralumab attenuates microglial activation in non-active secondary progressive multiple sclerosis patients with progression independent of relapse. The positive results suggest potential benefits for patients with this difficult-to-treat form of MS. The study, presented at the Annual Meeting of the American Academy of Neurology, demonstrates the effect of intranasal foralumab on microglial activation in na-SPMS patients using PET imaging. This breakthrough therapy has the potential to address the unmet need for disease-modifying treatments in progressive MS patients.
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Tiziana Life Sciences presents new quantitative PET imaging data on Foralumab at the American Academy of Neurology meeting. The study shows that intranasal Foralumab attenuates microglial activation and stabilizes disease progression in non-active secondary progressive MS patients with PIRA. The presentation includes encouraging imaging data from the Expanded Access Program, demonstrating the effectiveness of Foralumab in treating MS patients. The study highlights the significant impact of Foralumab in addressing the unmet need for effective treatments in progressive MS patients with PIRA.
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FAQ

What is the current stock price of Tiziana Life Sciences Ltd. Common Shares (TLSA)?

The current stock price of Tiziana Life Sciences Ltd. Common Shares (TLSA) is $0.9522 as of November 22, 2024.

What is the market cap of Tiziana Life Sciences Ltd. Common Shares (TLSA)?

The market cap of Tiziana Life Sciences Ltd. Common Shares (TLSA) is approximately 99.7M.

What is Tiziana Life Sciences Ltd. specialized in?

Tiziana Life Sciences Ltd. specializes in developing transformative therapies for neurodegenerative and lung diseases using innovative drug-delivery technologies.

What are the key compounds in Tiziana's pipeline?

The key compounds in Tiziana's pipeline are Milciclib, an inhibitor of cyclin-dependent kinases, and Foralumab, the only fully human-engineered anti-CD3 monoclonal antibody.

What recent clinical results has Tiziana announced?

Tiziana announced positive results from its Expanded Access Program for non-active secondary progressive multiple sclerosis (na-SPMS), where 70% of patients showed improvement in fatigue symptoms after six months of treatment with intranasal Foralumab.

Who are Tiziana Life Sciences' key partners?

Tiziana partners with prestigious institutions like Harvard Medical School and Brigham and Women's Hospital to advance its clinical research and development.

What diseases are targeted by Foralumab?

Foralumab targets multiple sclerosis, autoimmune diseases like ulcerative colitis, and inflammatory diseases such as Crohn's Disease and type-1 diabetes.

What is unique about Tiziana’s drug delivery approach?

Tiziana uses a nasal delivery method for Foralumab, which has demonstrated enhanced efficacy, safety, and tolerability compared to traditional intravenous delivery.

What is the status of Milciclib's clinical development?

Milciclib is currently in Phase II clinical trials for thymic carcinoma, aiming to provide a new treatment option for patients who have previously undergone chemotherapy.

Who leads Tiziana Life Sciences?

Tiziana is led by a team of experienced executives, including Chairman and acting CEO Gabriele Cerrone, who have extensive backgrounds in drug development and commercialization.

What is the significance of Tiziana's Expanded Access Program?

The Expanded Access Program allows patients with non-active secondary progressive multiple sclerosis (na-SPMS) to receive treatment with Foralumab, showing significant improvements in fatigue and stability in disease progression.

How does Tiziana Life Sciences contribute to biopharmaceutical research?

Tiziana is at the forefront of biopharmaceutical research, developing new therapies and drug delivery systems to address unmet needs in neurodegenerative and autoimmune diseases.

Tiziana Life Sciences Ltd. Common Shares

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