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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 a virtual Key Opinion Leader webinar scheduled for March 14, 2022, focusing on the clinical updates of foralumab in multiple sclerosis. Renowned experts, including Prof. Howard Weiner from Harvard, will discuss the significance of intranasal immunotherapy for neurodegenerative diseases. The event aims to detail recent clinical data where patients with Secondary Progressive Multiple Sclerosis were treated with foralumab. Attendees can register online and submit questions to the panel.
Tiziana Life Sciences (Nasdaq: TLSA) announced positive results from a six-month clinical trial of intranasal foralumab in a patient with Secondary Progressive Multiple Sclerosis (SPMS). The treatment was well-tolerated with no adverse reactions. Significant biological improvements included sustained inhibition of microglial activation and reduction of pro-inflammatory cytokines. The FDA authorized a second patient to receive therapy under an Expanded Access IND. A Key Opinion Leader (KOL) event will be held on March 14, 2022, to discuss findings.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced that its former subsidiary, AccuStem Sciences, published new data demonstrating that StemPrintER is a strong prognostic tool for distant recurrence risk in breast cancer. Analyzing 776 tumor samples from the TransATAC cohort showed that patients with a low StemPrintER Risk Score had a 5.8% risk of distant recurrence at 10 years, compared to 23.2% for high scores. This indicates StemPrintER's potential in clinical decision-making, alongside established tests.
Tiziana Life Sciences Ltd (Nasdaq: TLSA) has announced that CEO Dr. Kunwar Shailubhai will present at the 2022 BIO CEO & Investor Conference on February 14-15 in New York City. The company is pioneering novel immunotherapy delivery methods, focusing on its lead product, foralumab, an entirely human antibody. Recent studies suggest that nasally administered foralumab can effectively immunomodulate in COVID-19 patients and has shown promise for treating multiple sclerosis and inflammatory bowel diseases. Interim results will be shared in Q1 2022.
Tiziana Life Sciences Ltd (Nasdaq: TLSA) announced an amendment to its Investigational New Drug (IND) application for the oral formulation of foralumab, aimed at patients with mild-to-moderately active Crohn’s Disease. This would mark the first oral immunotherapy for this condition. If accepted by the FDA, Tiziana anticipates completing the Phase 1b clinical study by Q4 2022. The trial's primary focus is on safety, with a secondary assessment of pharmacodynamics. The amendment allows for a broader patient population and a shorter dosing regimen, addressing prior challenges in patient enrollment.
Tiziana Life Sciences Ltd (NASDAQ: TLSA) announced its CEO and Chief Scientific Officer, Kunwar Shailubhai, Ph.D., will participate in a virtual fireside chat at the B. Riley Securities 2022 Oncology Conference on January 27, 2022, at 4:00 p.m. EDT. The discussion will provide company updates focusing on breakthrough therapies for KRAS+ Non-Small Cell Lung Cancer and innovative drug delivery technologies. Tiziana's leading candidates include intranasal foralumab and milciclib, both showing favorable safety profiles and clinical responses in studies.
Tiziana Life Sciences (Nasdaq: TLSA) has announced a stock repurchase program authorized by its Board of Directors, allowing for the buyback of up to $5 million of the Company's common shares. This program is effective until December 31, 2022, and will utilize the Company's working capital. Executive Chairman Gabriele Cerrone expressed confidence in Tiziana’s growth opportunities, deeming the buyback an attractive use of capital, supported by a strong balance sheet. Tiziana develops innovative therapies through novel drug delivery methods that may enhance efficacy and safety.
Tiziana Life Sciences (Nasdaq: TLSA) announced the passing of Dr. Thomas Adams on January 9, 2022. He had served on the company's Board of Directors since February 2021. CEO Kunwar Shailubhai expressed deep sadness over Dr. Adams' loss, highlighting his value and inspiration to the team. Tiziana is focused on developing transformative therapies through innovative drug delivery methods, such as intranasal and oral routes, which aim to enhance safety and efficacy. The company’s lead candidates include intranasal foralumab and milciclib, showing promising safety profiles in clinical studies.
Tiziana Life Sciences (TLSA) announced a positive update regarding its treatment for secondary progressive multiple sclerosis (SPMS) using intranasal foralumab. The FDA has allowed enrollment of a second patient in the clinical trial, following favorable data from the first patient after three months of treatment, indicating safety and a positive response. Tiziana plans to expand its clinical trials in 2022 to address other conditions such as Crohn's Disease and Type 1 Diabetes. The ongoing monitoring of patient responses is expected to provide further insights by April 2022.
Tiziana Life Sciences (Nasdaq: TLSA) announced participation at the virtual Biotech Showcase Conference on January 10-12 and 17-19, 2022. Senior management will present and be available for one-on-one meetings throughout the event. Tiziana focuses on innovative drug delivery methods, including nasal, oral, and inhalation routes, to enhance immunotherapy efficacy and safety. Their lead candidates include intranasal foralumab and milciclib, both showing promising clinical results. For more details about the conference, registration is available online.
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