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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.
Precision BioSciences (Nasdaq: DTIL) has secured an exclusive license from Tiziana Life Sciences (Nasdaq: TLSA) to utilize foralumab, a human anti-CD3 monoclonal antibody, as a lymphodepletion agent in its allogeneic CAR T therapy development. The collaboration aims to enhance the therapeutic effectiveness of CAR T cells by improving their tolerance and long-term persistence. Precision will oversee the development and commercialization of foralumab, providing Tiziana with upfront, milestone, and royalty payments.
Tiziana Life Sciences plc (NASDAQ: TLSA) announced a strategic reorganization to establish Tiziana Life Sciences Ltd, a Bermuda-incorporated parent company. This change aims to align the company's listing with its primary US operations and facilitate a direct NASDAQ listing. Old Tiziana shareholders will exchange their shares for New Tiziana Shares at a 2-for-1 ratio, and Old Tiziana will then delist from the FCA and London Stock Exchange. The restructuring is expected to enhance liquidity and reduce costs for shareholders, with details of the scheme and necessary approvals to be communicated soon.
Tiziana Life Sciences (TLSA) announced the successful results of its pilot study on Foralumab, an intranasal anti-CD3 monoclonal antibody for COVID-19 treatment. The study showed a significant reduction in lung inflammation and pro-inflammatory biomarkers, including IL-6 and CRP. Treatment was well-tolerated with only mild adverse events reported. Following this, Tiziana plans to initiate a Phase 2 study in Brazil to further evaluate Foralumab's safety and efficacy in hospitalized COVID-19 patients. The promising data suggests a potential therapeutic benefit for immune hyperactivity in severe cases.
Tiziana Life Sciences (Nasdaq: TLSA) announced its ADS will trade ex-dividend from July 9, 2021. The non-cash dividend will consist of one Accustem Sciences Limited ADS, equivalent to two ordinary shares, for each TLSA ADS held. Payment of the dividend is scheduled for July 14, 2021. Shareholders who acquired TLSA ADS before the ex-dividend date are eligible for this dividend. For more details, refer to JP Morgan's notice.
Tiziana Life Sciences plc (Nasdaq: TLSA) announced that the SEC has declared effective the Forms 20-F and F-6 filed by Accustem Sciences Limited, allowing the completion of the spin-off of Accustem. Key dates include the demerger record time on October 30, 2020, and the issuance of Accustem shares to Tiziana shareholders starting July 8, 2021. Existing Tiziana DRs will remain valid without requiring exchange for new DRs.
Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS) has announced an interview with Dr. Howard Weiner, Chairman of its Scientific Advisory Board, to air on Bloomberg Markets today. The company focuses on innovative therapeutics in oncology and immunology, notably developing Milciclib for cancer and Foralumab for various autoimmune diseases including COVID-19 and multiple sclerosis. Foralumab is recognized as the only second-generation fully human anti-CD3 monoclonal antibody in clinical development globally.
Tiziana Life Sciences held its Annual General Meeting on June 25, 2021, where all resolutions were approved. The company announced the re-activation of its strategic plan to redomicile to Bermuda, with further information to be provided to shareholders. The results of proxy voting will be available on the company's website.
Tiziana Life Sciences focuses on developing novel therapies in oncology and immunology, including Milciclib and Foralumab, a second generation human anti-CD3 monoclonal antibody for various autoimmune diseases.
Tiziana Life Sciences (NASDAQ: TLSA) has entered into an agreement with FHI Clinical to conduct a Phase 2 proof-of-concept study in Brazil, evaluating the safety and efficacy of intranasal Foralumab for severe COVID-19 patients. This randomized, placebo-controlled trial aims to build on earlier findings in non-hospitalized patients. It will involve up to 80 participants with pulmonary inflammation, assessing various health metrics after 14 days of treatment. This pivotal study is expected to enhance the understanding of Foralumab's potential in treating COVID-19-related complications.
Tiziana Life Sciences has appointed Dr. Kevin Schutz as Vice-President of Regulatory Affairs, strengthening its global development capabilities. Dr. Schutz, with over 19 years in the pharmaceutical sector, will manage regulatory interactions for clinical studies across the U.S., Europe, and Asia. His expertise includes working with regulatory agencies such as the FDA and EMA, essential for the company’s clinical pursuits. Tiziana focuses on innovative treatments for diseases like multiple sclerosis and COVID-19, with its lead candidate, Foralumab, showing promise for various indications.
Tiziana Life Sciences (NASDAQ: TLSA) has submitted a grant proposal to the UK COVID Therapeutics Advisory Panel to advance the clinical development of Foralumab, an innovative nasal treatment for non-hospitalized COVID-19 patients. This initiative aligns with the UK government's call for at-home therapies. Previous studies in Brazil showed that Foralumab effectively reduced lung inflammation in COVID-19 patients. Additionally, a separate clinical trial for hospitalized patients is in the works. Foralumab could potentially address various COVID-19 variants, enhancing treatment options.
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