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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. (Nasdaq: TLSA) announced a corporate update focusing on the development of intranasal foralumab for CNS inflammatory diseases. The company aims to prioritize resources for this therapeutic candidate, leveraging positive preclinical results. Upcoming milestones include results from PET scans for patients with non-active secondary-progressive Multiple Sclerosis expected in Q1 2023, and plans for an FDA Type C meeting regarding its Phase 2 program. Tiziana has sufficient capital to fund developments until Q1 2024.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA), a clinical-stage biotechnology company, announced an investor call and webcast scheduled for November 10, 2022, at 10 a.m. ET. This session will provide insights into their innovative immunomodulation therapies utilizing novel drug delivery methods. Tiziana's leading candidates include intranasal foralumab and milciclib, both showing promising safety profiles and clinical responses. The company focuses on alternative routes for immunotherapy, aiming to enhance efficacy and safety compared to traditional IV delivery.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced that Panetta Partners Limited, associated with Executive Chairman Gabriele Cerrone, purchased 7,000 common shares at $0.69 each. With this transaction, Cerrone's overall interest in Tiziana remains significant at 37.70%. Tiziana focuses on innovative drug delivery technologies for immunotherapies, including its lead candidates: intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor. These candidates are showing favorable safety profiles and responses in clinical studies.
Tiziana Life Sciences (Nasdaq: TLSA) has completed enrollment of the first patient cohort (n=4) in its Expanded Access Program for foralumab, a treatment for non-active Secondary Progressive Multiple Sclerosis (SPMS). Conducted at Brigham and Women’s Hospital, the program assesses two dosing levels: 50 mcg and 100 mcg. This initiative follows positive feedback from investigators and aims to validate the clinical benefits of foralumab, with results from initial PET scans expected soon, potentially paving the way for Phase 2 studies in the coming year.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced the enrollment of its first patient cohort in an Expanded Access Program to evaluate foralumab in non-active Secondary Progressive Multiple Sclerosis (SPMS) patients. This program includes two cohorts of four patients each, testing standard and higher dosing of foralumab. Conducted at Brigham and Women’s Hospital, the study aims to assess the clinical benefits of intranasal foralumab, with PET scans for initial patients scheduled in the coming months, supporting a Phase 2 study expected to begin in mid-to-late 2023.
Tiziana Life Sciences Ltd (NASDAQ: TLSA) will participate in The ThinkEquity Conference on October 26, 2022, at The Mandarin Oriental Hotel, New York. Dr. Matthew W. Davis will present at 2:30 p.m. ET, with live streaming available. Tiziana is focused on innovative immunomodulation therapies through alternative drug delivery methods like nasal and oral routes. Their leading candidates, intranasal foralumab and milciclib, have shown favorable clinical responses. This conference will connect industry insiders and investors, featuring presentations and discussions across various sectors.
Tiziana Life Sciences (Nasdaq: TLSA) announced plans to submit an Investigational New Drug Application (IND) for a Phase 1 trial of intranasal foralumab targeting Alzheimer's disease after receiving feedback from the FDA. The IND is expected to be filed in Q3 2023, pending toxicology study completions, with the trial commencing by year-end. Foralumab, a fully human anti-CD3 monoclonal antibody, has shown promise in treating CNS-related inflammatory diseases. The company aims to explore its efficacy in other conditions such as Multiple Sclerosis and Amyotrophic Lateral Sclerosis.
Tiziana Life Sciences (Nasdaq: TLSA) presented poster exhibits on intranasal foralumab for treating Progressive Multiple Sclerosis (MS) at the "Preserving the Brain" conference in Milan, Italy. The presentation included results from animal models, healthy subjects, and patients with Progressive MS. Dr. Howard L. Weiner interviewed the first patient treated with intranasal foralumab during the event. Gabriele Cerrone, Executive Chairman, expressed excitement over the recognition of this therapy. The conference aims to advance discussions on neurodegenerative diseases and will run until October 10, 2022.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced positive developments regarding its intranasal foralumab treatment for non-active secondary progressive multiple sclerosis (SPMS). The second Expanded Access patient (EA2) exhibited improved walking ability, requiring no cane for 100 meters, and showed a clinically significant 0.5 point decrease on the Expanded Disability Status Scale (EDSS). These results will be further evaluated with PET imaging to assess microglial activation in Q4 2022. The company plans to enroll four additional patients at Brigham and Women’s Hospital during the same period.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced that Panetta Partners Limited, linked to Executive Chairman Gabriele Cerrone, purchased 29,318 common shares at prices between $0.78 and $0.81, increasing Cerrone's stake from 37.70% to 37.72%. The company focuses on developing innovative drug delivery technologies for immunotherapies, with two lead candidates showing favorable safety and efficacy in clinical studies. Tiziana aims to enhance immunotherapy efficacy through alternative delivery methods such as nasal and oral routes.
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