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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 (TLSA) recently announced significant findings on the utilization of intranasal anti-CD3 monoclonal antibodies (mAb) for treating intracerebral hemorrhage (ICH) at the Annual American Academy of Neurology conference. ICH, with a mortality rate of 30% to 40%, currently has no effective treatments. The study demonstrated that intranasal foralumab significantly reduced ICH injury severity, improved motor coordination, memory retention, and accelerated hematoma resolution. It also showed a reduction in neuronal cell death and blood-brain barrier leakage. Gabriele Cerrone, the CEO, emphasized the potential of foralumab in neuroinflammation treatment, paving the way for broader applications and potential shareholder value creation. Phase 2 trials are expected to begin in Q3 2023.
Tiziana Life Sciences (Nasdaq: TLSA) reported its financial results for 2022, showing a loss of $19.0 million, improved from $27.9 million in 2021. R&D expenses slightly decreased to $13.0 million primarily due to focusing on foralumab. The company ended 2022 with $18.1 million in cash. Tiziana is prioritizing intranasal foralumab for treating CNS-related inflammatory diseases, including Alzheimer’s and Type 1 diabetes. It plans to file an IND for Alzheimer’s trials by Q2 2023 and has reported positive developments in its Expanded Access Program for multiple sclerosis. Tiziana's intranasal foralumab has been recognized in major medical publications and is anticipated to enter Phase 2 studies this year.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) has announced that it has regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market. The company was previously notified on June 14, 2022, of its non-compliance due to its stock closing below $1.00 for 30 consecutive business days. Tiziana successfully maintained a closing bid price of $1.00 or more for at least ten consecutive trading days, achieving compliance as of April 20, 2023. The company is focused on developing innovative immunomodulation therapies, particularly through its lead candidate, intranasal foralumab, which aims to improve efficacy and safety compared to traditional intravenous therapies.
Tiziana Life Sciences Ltd. (TLSA) announced plans to submit an IND for intranasal foralumab in Alzheimer’s patients during Q2 2023, following FDA Type “B” meeting feedback. The company seeks $3M in non-dilutive funding from an Alzheimer’s foundation to support a Phase 2a trial aimed at assessing the drug’s effects on neuroinflammation related to microglia activation.
The study aims to administer intranasal foralumab over three months to evaluate its potential in restoring the neuroinflammatory activated state of microglia in Alzheimer’s patients. There are currently no approved treatments for neuroinflammation specifically triggered by amyloid beta plaque.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced the initiation of a program to develop its intranasal foralumab, a fully human CD3 antibody, for treating or preventing Type 1 Diabetes. Following the $2.9 billion acquisition of Provention Bio by Sanofi, CD3 antibodies have become an attractive target in diabetes treatments. Foralumab’s unique delivery method aims to provide a non-injection alternative that might enhance patient compliance. The company plans to commence Phase 2 trials in non-active Secondary Progressive Multiple Sclerosis (SPMS) in the third quarter of 2023. The ongoing discussions with diabetes experts will refine the study designs for foralumab, which has previously shown promise in various chronic diseases and patient safety.
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