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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 (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.
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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