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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) has received a prestigious grant from the ALS Association for research on an intranasal anti-CD3 monoclonal antibody aimed at combating Amyotrophic Lateral Sclerosis (ALS) at Brigham and Women’s Hospital. The grant will facilitate studies on dampening microglial activation linked to ALS progression. Tiziana's foralumab, the first entirely human anti-CD3 monoclonal antibody, shows promise in treating various neuroinflammatory conditions including ALS and Alzheimer’s Disease. The company emphasizes the significant unmet need for effective ALS therapies.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced the purchase of 100,000 common shares by Chief Medical Officer Matthew Davis at $0.76 per share. This move reflects confidence in the company’s future amidst its development of innovative immunotherapies using alternative drug delivery methods. Tiziana's flagship products, intranasal foralumab and milciclib, have shown promising safety profiles and clinical responses. The company focuses on transforming immunotherapy delivery to enhance efficacy and safety compared to traditional intravenous methods.
Tiziana Life Sciences (Nasdaq: TLSA) announced that Panetta Partners Limited acquired 20,000 common shares at $0.75 each, increasing Executive Chairman Gabriele Cerrone's ownership from 37.60% to 37.61%. Tiziana is focused on developing innovative immunotherapies through novel drug delivery methods, including intranasal and oral routes, which show potential for better efficacy and safety compared to traditional IV methods. Their lead candidates, intranasal foralumab and milciclib, have shown favorable safety profiles and clinical responses in studies.
Tiziana Life Sciences (Nasdaq: TLSA) announced a study showing improved cognitive function and restored microglia homeostasis in animal models of Alzheimer’s disease. The research focused on intranasal anti-CD3 monoclonal antibody and was presented at the AAIC on July 31, 2022. With promising results, the company is considering clinical trials of Foralumab in Alzheimer’s patients. Dr. Howard Weiner emphasized its potential to modulate microglial activity and reduce inflammation, making it a novel approach for treating progressive neurological disorders.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced the appointment of Matthew Davis, MD, RPh as the Chief Medical Officer and Acting Chief Scientific Officer, effective immediately. Dr. Davis, with 25 years of pharmaceutical experience and notable FDA approvals under his belt, is expected to drive Tiziana's shift towards proof-of-concept clinical trials. His leadership is aimed at enhancing the development of therapies for Secondary-Progressive Multiple Sclerosis, Crohn's Disease, and KRAS+ NSCLC.
Tiziana Life Sciences (NASDAQ: TLSA) announced the resignation of Dr. Kunwar Shailubhai as CEO, CSO, and Board director effective August 1, 2022, due to personal reasons. The resignation is not related to any operational disagreements. Gabriele Cerrone, Executive Chairman, will serve as interim CEO while the Board searches for a permanent replacement. The company continues to advance its foralumab clinical programs and will provide progress updates in due course.
Tiziana Life Sciences (TLSA) announced on June 14, 2022, that it received a notice from Nasdaq regarding non-compliance with the $1.00 minimum bid price for continued listing on the Nasdaq Global Market. The Company has 180 days to regain compliance by maintaining the closing bid price at or above $1.00 for at least ten consecutive business days. The notice does not affect the current trading of its securities. Tiziana aims to resolve this deficiency and may consider options to meet the bid price requirement before the compliance deadline of December 12, 2022.
Tiziana Life Sciences (Nasdaq: TLSA) announced on June 10, 2022, that Panetta Partners Limited, associated with Executive Chairman Gabriele Cerrone, purchased 50,000 common shares at $0.88 each. This acquisition increased Cerrone's stake from 37.60% to 37.64%. Tiziana specializes in developing innovative immunotherapy delivery methods, focusing on alternative routes such as nasal, oral, and inhalation. Their leading candidates include intranasal foralumab and milciclib, both of which have shown favorable safety profiles in clinical studies.
Tiziana Life Sciences PLC (NASDAQ: TLSA) announced positive clinical results for its second patient in a secondary progressive multiple sclerosis (SPMS) trial. The patient showed improvements in PET analysis and neurologic exams after three months of treatment with intranasal foralumab. Following these findings, the FDA approved the enrollment of eight additional patients in the trial. Tiziana aims to escalate dosing to potentially enhance clinical benefits. The company anticipates enrolling the third patient by July 2022 and expects to release data on all ten patients in 2023.
Tiziana Life Sciences (TLSA) announced positive clinical outcomes from its ongoing study on Foralumab for patients with Secondary Progressive Multiple Sclerosis (SPMS) during a recent interview. Conducted at Brigham and Women’s Hospital, the trial highlights the potential of Foralumab, the only fully human anti-CD3 mAb, in managing autoimmune diseases. The treatment has shown favorable safety profiles and effective immune response modulation. Tiziana focuses on innovative drug delivery technologies, aiming to improve patient outcomes by offering alternative routes for immunotherapy.
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