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Tiziana Life Sciences reports positive 3-month neuroimaging scores in multiple sclerosis patients receiving intranasal foralumab. The company announced quantitative data showing improvement in White Matter Z-scores in patients with non-active secondary progressive multiple sclerosis. Dr. Tarun Singhal presented data demonstrating a reduction in microglial activation, indicating a positive effect on brain inflammation. A peer-reviewed journal has published the research findings. Tiziana is currently conducting a double-blind, placebo-controlled study to further evaluate intranasal foralumab's impact.
Tiziana Life Sciences riporta risultati positivi nei punteggi di neuroimaging a 3 mesi in pazienti affetti da sclerosi multipla che hanno ricevuto foralumab intranasale. La compagnia ha annunciato dati quantitativi che mostrano un miglioramento nei punteggi Z della sostanza bianca in pazienti con sclerosi multipla secondaria progressiva non attiva. Il Dr. Tarun Singhal ha presentato dati che dimostrano una riduzione dell'attivazione microgliale, indicando un effetto positivo sull'infiammazione cerebrale. Una rivista sottoposta a revisione paritaria ha pubblicato i risultati della ricerca. Attualmente, Tiziana sta conducendo uno studio in doppio cieco, controllato con placebo per valutare ulteriormente l'impatto del foralumab intranasale.
Tiziana Life Sciences reporta resultados positivos en las evaluaciones de neuroimagen a los 3 meses en pacientes con esclerosis múltiple que recibieron foralumab intranasal. La compañía anunció datos cuantitativos que muestran una mejora en las puntuaciones Z de la materia blanca en pacientes con esclerosis múltiple secundaria progresiva no activa. El Dr. Tarun Singhal presentó datos que demuestran una reducción en la activación microglial, indicando un efecto positivo sobre la inflamación cerebral. Una revista revisada por pares ha publicado los hallazgos de la investigación. Actualmente, Tiziana está realizando un estudio doble ciego controlado con placebo para evaluar más a fondo el impacto del foralumab intranasal.
Tiziana Life Sciences는 체강 내로 투여된 포랄루맙을 받은 다발성 경화증 환자들에서 긍정적인 3개월 신경영상 점수를 보고했습니다. 회사는 비활동성 이차 진행성 다발성 경화증을 앓고 있는 환자들의 백질 Z-점수 개선을 보여주는 정량적 데이터를 발표했습니다. 타룬 싱할 박사는 뇌 염증에 긍정적인 효과를 나타내는 미세아교세포 활성 감소를 입증하는 데이터를 제시했습니다. 이 연구 결과는 동료 평가 저널에 게재되었습니다. Tiziana는 현재 이중 맹검, 위약 대조 연구를 진행 중으로 코로 투여된 포랄루맙의 영향을 더 평가하고 있습니다.
Tiziana Life Sciences rapporte des scores d'imagerie neurologique positifs à 3 mois chez des patients atteints de sclérose en plaques recevant du foralumab par voie intranasale. L'entreprise a annoncé des données quantitatives montrant une amélioration des scores Z de la substance blanche chez les patients atteints de sclérose en plaques secondaire progressive non active. Le Dr Tarun Singhal a présenté des données démontrant une réduction de l'activation microgliale, indiquant un effet positif sur l'inflammation cérébrale. Un journal revu par des pairs a publié les résultats de la recherche. Tiziana mène actuellement une étude en double aveugle, contrôlée par placebo, pour évaluer plus avant l'impact du foralumab intranasal.
Tiziana Life Sciences berichtet über positive Ergebnisse von dreimonatigen Neurobildgebungsdaten bei Multiple-Sklerose-Patienten, die intranasales Foralumab erhalten haben. Das Unternehmen gab quantitative Daten bekannt, die eine Verbesserung der Z-Werte der weißen Substanz bei Patienten mit nicht aktiver sekundär progressiver Multipler Sklerose zeigen. Dr. Tarun Singhal präsentierte Daten, die eine Reduzierung der Mikroglia-Aktivierung zeigen und somit einen positiven Effekt auf die Gehirnentzündung anzeigen. Ein von Fachleuten begutachtetes Journal hat die Forschungsergebnisse veröffentlicht. Tiziana führt derzeit eine doppelblinde, placebokontrollierte Studie durch, um die Auswirkungen von intranasalem Foralumab weiter zu bewerten.
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The recent announcement by Tiziana Life Sciences regarding their foralumab treatment presents promising advances in the management of non-active Secondary Progressive Multiple Sclerosis. The reported 28% to 48% reductions in White Matter Z-scores, which gauge brain abnormalities, are substantial. For investors, it is essential to recognize the significance of these early-stage results within the larger context of drug development. Further drug validation through the double-blind, placebo-controlled study is important in determining foralumab's efficacy and safety profile. The incorporation of [F-18]PBR06-PET imaging as a primary endpoint could potentially lead to a more precise understanding of the treatment’s impact on the central nervous system. This study could lead to a pivotal role of foralumab in a market with limited options for progressive forms of MS, thus potentially enhancing Tiziana's market value should the clinical trials render positive outcomes. However, the timeline for drug development, regulatory approval and market entry should temper immediate expectations, as substantial investments and time are required before potential FDA approval and commercialization.
From a financial standpoint, the development of intranasal foralumab represents a strategic investment into a specialized segment of the biotech industry. Positive clinical trial results tend to have a favorable impact on a biotech company's stock price due to the prospect of future revenue from new therapies. Investors should monitor the progress of the aforementioned dose-ranging study, given its potential to act as a catalyst for Tiziana's share price. Moreover, the interest of the scientific community, as evidenced by the peer-reviewed publication, may attract further investment. However, the cost of ongoing clinical trials and potential commercialization will exert financial pressure on Tiziana. Investors should weigh the risks of clinical trial failures, which could negatively impact the company's financial health and stock performance. Additionally, the therapeutic market for MS is competitive and Tiziana's success will depend on how effectively they can navigate clinical trials, regulatory hurdles and market penetration against established treatments.
The successful application of novel PET imaging to measure treatment efficacy signifies a broader trend within the biotech industry towards more precise and targeted approaches to disease management. Intranasal foralumab's development rides the wave of innovation in drug delivery systems, which could lead to a differentiated product in the crowded MS treatment landscape. The specificity of [F-18]PBR06-PET as a biomarker for microglial activation offers a nuanced pathway for tracking disease progression and treatment efficacy, possibly setting a new standard for future MS drug trials. While Tiziana is capturing the attention with these developments, the larger biotech sector may take cue and intensify research in targeted therapies and advanced diagnostics. The versatility of foralumab could potentially open avenues for applications in other neurological conditions, thus expanding the therapeutic reach and market potential for Tiziana. Investors with a stake in the biotech sector should be aware of these industry shifts, as they could affect broader market dynamics and investment strategies.
NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced for the first time, quantitative data showing improvement in White Matter Z-scores measured from PET images taken at 3 months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS). White Matter Z-scores are a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain.
Tarun Singhal, MBBS, M.D., Director of PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, stated, “Last week at the American Academy of Neurology annual meeting, we presented, for the first time, quantitative [F18]PBR06-PET data showing the dampening of microglial activation, an indicator of brain inflammation, in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) receiving intranasal foralumab. These data came from the open-label intermediate-sized patient population Expanded Access (ISPPEA) program. We calculated White Matter Z-scores to measure the effect of intranasal foralumab on microglial activation at baseline and then after foralumab treatment for three months. We saw reductions of 28% to 48%, indicating improvement in 5 out of 6 patients, and a 36% median reduction in White Matter Z-scores compared to baseline (see Figure 1). A peer-reviewed journal has published our recent work with newer [F18]PBR06-PET quantitation approaches.”[1]
“I am grateful for Dr. Singhal’s work advancing our intranasal foralumab program and the insight his work provides into the foralumab’s effect on brain inflammation. We are seeing this additional, encouraging evidence of intranasal foralumab’s effect after reporting that it attenuated microglial activation in na-SPMS patients with progression independent of relapse activity (PIRA) at 3 months as evaluated by [F-18]PBR06-PET and was associated with clinical symptom improvement or stability. Based on these positive results, a double-blind, placebo-controlled, dose-ranging study (NCT06292923) of intranasal foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint with clinical measures of EDSS (disability) and MFIS (fatigue) is currently underway. I welcome the publication of Dr. Singhal’s [F18]PBR06-PET research paper, highlighting these combined findings in Clinical Nuclear Medicine,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences.
Figure 1*
*EA5 showed a worsening in their White Matter Z-Score at three months during a pseudo-exacerbation of the patient’s trigeminal neuralgia.
About Foralumab
Activated T cells play an essential role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial began screening patients in November 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treating neuroinflammatory and neurodegenerative human diseases.[2],[3]
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For further inquiries:
Tiziana Life Sciences Ltd Paul Spencer, Business Development and Investor Relations +44 (0) 207 495 2379 email: info@tizianalifesciences.com
What did Tiziana Life Sciences report regarding multiple sclerosis patients and intranasal foralumab?
Tiziana Life Sciences reported positive 3-month neuroimaging scores in multiple sclerosis patients receiving intranasal foralumab.
What are White Matter Z-scores and how are they used in neuroimaging studies?
White Matter Z-scores are a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain.
Who presented the quantitative [F18]PBR06-PET data regarding intranasal foralumab treatment in multiple sclerosis patients?
Dr. Tarun Singhal presented the quantitative [F18]PBR06-PET data.
What did the data show in terms of microglial activation reduction in patients with non-active secondary progressive multiple sclerosis?
The data showed a reduction in microglial activation, indicating a positive effect on brain inflammation.
Where can the full publication of the recent work with [F18]PBR06-PET quantitation approaches be found?
The full publication can be found in Clinical Nuclear Medicine at https://journals.lww.com/nuclearmed/fulltext/9900/glial_activity_load_on_pet_reveals_persistent.1077.aspx
What study is Tiziana currently conducting to further evaluate intranasal foralumab's impact?
Tiziana is currently conducting a double-blind, placebo-controlled study with [F-18]PBR06-PET as a primary endpoint and clinical measures of EDSS and MFIS.
Who is the Chairman, acting CEO, and founder of Tiziana Life Sciences?
Gabriele Cerrone is the Chairman, acting CEO, and founder of Tiziana Life Sciences.
tiziana life sciences plc is a uk biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology. the company is focused on its lead compound, milciclib, a molecule which blocks the action of specific enzymes called cyclin-dependent kinases (cdk) involved in cell division as well as a number of other protein kinases. milciclib is currently in phase ii clinical trials for thymic carcinoma in patients previously treated with chemotherapy. the company is also in clinical development of foralumab. foralumab is the only fully human engineered anti-human cd3 antibody in clinical development. this phase ii compound has potential application in a wide range of autoimmune and inflammatory diseases, such as ulcerative colitis, multiple sclerosis, type-1 diabetes (t1d), inflammatory bowel disease (ibd), psoriasis and rheumatoid arthritis, where modulation of a t-cell response is desirable. tiziana life sciences’ research
