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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 PLC (NASDAQ: TLSA) announced positive clinical results for its second patient with secondary progressive multiple sclerosis (SPMS) on June 8, 2022. The patient demonstrated significant clinical improvements, including a 10-30% reduction in microglial activation after three months of treatment with intranasal foralumab. Following the success of the first two patients, the FDA has approved the enrollment of eight more patients under the Expanded Access Program. The company aims to investigate higher dosing levels and expects to enroll a third patient in July 2022.
Tiziana Life Sciences (Nasdaq: TLSA) has announced that Panetta Partners Limited, associated with Executive Chairman Gabriele Cerrone, acquired 18,000 common shares at $0.80 each. This purchase increased Cerrone’s beneficial ownership from 37.58% to 37.60% of the company. Tiziana is focused on developing innovative immunotherapies using alternative drug delivery methods, including intranasal and inhalation approaches, with its lead candidates showing favorable safety profiles and clinical responses.
Tiziana Life Sciences (Nasdaq: TLSA) announced promising clinical results for its intranasal therapy with foralumab in treating Secondary Progressive Multiple Sclerosis (SPMS). Positive outcomes were observed in two patients, demonstrating improvements in PET imaging and neurologic exams after three months of treatment. The FDA has authorized enrollment of an additional eight SPMS patients in the expanded access program. Both patients continue treatment, with the potential for dosage escalation to enhance clinical benefits.
Tiziana Life Sciences (NASDAQ: TLSA) announced that CEO Kunwar Shailubhai will present at the BIO Annual Convention in San Diego from June 13-16, 2022. His focus will be on recent clinical updates for foralumab, an anti-CD3 monoclonal antibody, specifically regarding nasal administration for secondary progressive multiple sclerosis. Additionally, he will discuss the Phase 1b trial for oral capsules of foralumab aimed at treating Crohn’s Disease. Tiziana's management will also conduct one-on-one meetings at the event.
Tiziana Life Sciences (TLSA) announced Dr. Tanuja Chitnis will present clinical data on foralumab, an intranasal anti-CD3 monoclonal antibody, at the CMSC 2022 Annual Meeting from June 1-4. This presentation will focus on a patient with secondary progressive multiple sclerosis treated for six months. The data highlights the potential of foralumab to reduce microglial activation and blood inflammatory markers. The session is scheduled for June 2, 2022, at 5 PM EDT. Foralumab, a unique human anti-CD3 mAb, shows promise in treating autoimmune diseases.
Tiziana Life Sciences (Nasdaq: TLSA) announced the filing of its Annual Report on Form 20-F for the year ended December 31, 2021, on May 23, 2022. Following this filing, the company confirmed it has regained compliance with Nasdaq Listing Rules. Tiziana is focused on developing innovative immunotherapy delivery methods, including intranasal foralumab, which is the only fully human anti-CD3 monoclonal antibody, and milciclib, a pan-CDK inhibitor. The company’s alternative drug delivery technologies aim to enhance efficacy, safety, and tolerability.
Tiziana Life Sciences Ltd (NASDAQ: TLSA) announced that its CEO and CSO, Kunwar Shailubhai, Ph.D., will participate in a fireside chat at the B. Riley Securities 2022 Virtual Neuro & Ophthalmology Conference on April 27, 2022, at 2:30 p.m. ET. The discussion will focus on updates regarding the company's innovative biopharmaceutical developments, particularly its intranasal foralumab treatment for Secondary Progressive Multiple Sclerosis. Tiziana aims to revolutionize immunotherapy delivery with its novel approaches.
Tiziana Life Sciences (TLSA) has received FDA approval to expand its Intermediate-Size Patient Population Access program for its intranasal foralumab treatment in secondary progressive multiple sclerosis (SPMS). Following promising clinical responses from two patients, Tiziana aims to initiate treatment for eight additional patients. The dosing regimen will remain at 50 mcg three times a week, with the potential for dose escalation. The study is expected to begin in July 2022, focusing on safety, tolerability, and clinical benefits.
Tiziana Life Sciences (NASDAQ: TLSA) has initiated a Phase 1b clinical trial for foralumab, an oral immunotherapy for mild-to-moderate Crohn's Disease (CD). This trial, expected to conclude by Q4 2022, aims to evaluate the safety and tolerability of a new enteric-coated capsule formulation. The study will also assess clinical responses and pharmacokinetics. Foralumab represents a significant departure from traditional intravenous or subcutaneous therapies, potentially offering improved patient compliance and fewer side effects.
Tiziana Life Sciences (Nasdaq: TLSA) announces the replay availability of its March 14 KOL event, "Foralumab Clinical Update in Multiple Sclerosis," along with presentation slides on its website. Zacks released a research note discussing positive clinical data for a SPMS patient treated for six months. Tiziana is focused on innovative immunotherapy approaches, including intranasal foralumab and milciclib, which have shown favorable safety profiles in studies. The company is advancing transformational drug delivery technologies aimed at improving efficacy and safety.
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