Tiziana Life Sciences Announces Interview Highlighting Intranasal Foralumab for the Treatment of Moderate Alzheimer’s Disease
Tiziana Life Sciences (NASDAQ: TLSA) has showcased promising developments in their intranasal foralumab treatment for moderate Alzheimer's disease through a national radio interview. The treatment, a fully human anti-CD3 monoclonal antibody administered as a nasal spray, targets brain inflammation associated with Alzheimer's progression. Dr. Howard Weiner highlighted remarkable results from the first patient, Joe Walsh, at Brigham and Women's Hospital in Boston. According to Walsh's wife Karen, the treatment has led to noticeable improvements in his social engagement and overall condition. The case represents an encouraging advancement in Alzheimer's treatment, particularly in addressing brain inflammation as a key factor in disease progression.
Tiziana Life Sciences (NASDAQ: TLSA) ha presentato sviluppi promettenti nel loro trattamento intranasale con foralumab per l'Alzheimer moderato durante un'intervista radiofonica nazionale. Il trattamento, un anticorpo monoclonale anti-CD3 completamente umano somministrato come spray nasale, mira all'infiammazione cerebrale associata alla progressione dell'Alzheimer. Il dottor Howard Weiner ha sottolineato risultati straordinari ottenuti dal primo paziente, Joe Walsh, presso il Brigham and Women's Hospital di Boston. Secondo la moglie di Walsh, Karen, il trattamento ha portato a miglioramenti evidenti nel suo coinvolgimento sociale e nelle sue condizioni generali. Questo caso rappresenta un progresso incoraggiante nel trattamento dell'Alzheimer, in particolare nel contrastare l'infiammazione cerebrale come fattore chiave nella progressione della malattia.
Tiziana Life Sciences (NASDAQ: TLSA) ha presentado avances prometedores en su tratamiento intranasal con foralumab para el Alzheimer moderado durante una entrevista nacional en radio. El tratamiento, un anticuerpo monoclonal anti-CD3 completamente humano administrado como spray nasal, se dirige a la inflamación cerebral asociada con la progresión del Alzheimer. El Dr. Howard Weiner destacó resultados notables del primer paciente, Joe Walsh, en el Brigham and Women's Hospital de Boston. Según Karen, esposa de Walsh, el tratamiento ha provocado mejoras visibles en su interacción social y en su estado general. Este caso representa un avance alentador en el tratamiento del Alzheimer, especialmente en abordar la inflamación cerebral como un factor clave en la progresión de la enfermedad.
Tiziana Life Sciences(NASDAQ: TLSA)는 전국 라디오 인터뷰를 통해 중등도 알츠하이머병 치료용 비강 투여 포랄루맙 치료제의 유망한 발전을 선보였습니다. 이 치료제는 완전 인간형 항-CD3 단클론 항체로 비강 스프레이 형태로 투여되며, 알츠하이머 진행과 관련된 뇌 염증을 표적으로 합니다. 하워드 와이너 박사는 보스턴 브리검 여성 병원에서 첫 환자인 조 월시의 놀라운 결과를 강조했습니다. 월시의 아내 카렌에 따르면, 이 치료는 그의 사회적 교류와 전반적인 상태에 눈에 띄는 개선을 가져왔습니다. 이 사례는 알츠하이머 치료에서 뇌 염증을 질병 진행의 핵심 요인으로 다루는 데 있어 고무적인 진전을 의미합니다.
Tiziana Life Sciences (NASDAQ : TLSA) a présenté des avancées prometteuses dans leur traitement intranasal au foralumab pour la maladie d'Alzheimer modérée lors d'une interview nationale à la radio. Ce traitement, un anticorps monoclonal anti-CD3 entièrement humain administré sous forme de spray nasal, cible l'inflammation cérébrale associée à la progression de la maladie d'Alzheimer. Le Dr Howard Weiner a souligné des résultats remarquables chez le premier patient, Joe Walsh, à l'hôpital Brigham and Women's de Boston. Selon Karen, l'épouse de Walsh, le traitement a entraîné des améliorations notables dans son engagement social et son état général. Ce cas représente une avancée encourageante dans le traitement de la maladie d'Alzheimer, notamment en ciblant l'inflammation cérébrale comme facteur clé de la progression de la maladie.
Tiziana Life Sciences (NASDAQ: TLSA) hat in einem nationalen Radiointerview vielversprechende Fortschritte bei ihrer intranasalen Foralumab-Behandlung für mittelschwere Alzheimer-Erkrankung vorgestellt. Die Behandlung, ein vollständig humaner anti-CD3 monoklonaler Antikörper, der als Nasenspray verabreicht wird, zielt auf die mit dem Fortschreiten der Alzheimer-Krankheit verbundene Gehirnentzündung ab. Dr. Howard Weiner hob bemerkenswerte Ergebnisse des ersten Patienten, Joe Walsh, am Brigham and Women's Hospital in Boston hervor. Laut Walshs Ehefrau Karen führte die Behandlung zu spürbaren Verbesserungen seiner sozialen Interaktion und seines Allgemeinzustands. Dieser Fall stellt einen ermutigenden Fortschritt in der Alzheimer-Behandlung dar, insbesondere bei der Bekämpfung der Gehirnentzündung als Schlüsselfaktor im Krankheitsverlauf.
- None.
- None.
Insights
Tiziana reports encouraging early results for intranasal foralumab in treating brain inflammation associated with moderate Alzheimer's disease.
The press release highlights early clinical experience with intranasal foralumab, a fully human anti-CD3 monoclonal antibody being developed by Tiziana Life Sciences for moderate Alzheimer's disease. What makes this approach scientifically interesting is the intranasal delivery method, which allows the monoclonal antibody to target immune cells in the brain directly - potentially addressing the neuroinflammatory component of Alzheimer's pathophysiology.
The data presented comes from a single patient case study (Joe Walsh) treated at Brigham and Women's Hospital in Boston. Dr. Howard Weiner, presumably the principal investigator, expressed enthusiasm about the observed reduction in brain inflammation, stating he's "never seen anything like this" - suggesting the treatment may be producing unusual or unexpected positive results in this patient.
The patient's wife reported subjective improvements in engagement and social participation. While these anecdotal observations from a single case are encouraging, they represent the absolute earliest stage of clinical evidence. No quantitative data, cognitive assessments, biomarker measurements, or trial design details are provided.
This represents a very preliminary report on a novel therapeutic approach. While targeting neuroinflammation in Alzheimer's has strong scientific rationale, the current evidence consists solely of qualitative observations from a single case. This is far from sufficient evidence to draw conclusions about efficacy or safety. The company will need to demonstrate reproducible results in properly designed clinical trials with appropriate endpoints and statistical power before any definitive conclusions can be drawn about foralumab's potential in Alzheimer's treatment.
NEW YORK, May 23, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced advancements in moderate Alzheimer's disease treatment, showcased in a recent feature on a national public radio station across the United States. The advancement involves the use of Tiziana’s novel nasal spray, foralumab, which is designed to combat brain inflammation, marking a step forward in moderate Alzheimer's research and treatment.
In the exclusive interview, Dr. Howard Weiner shared promising results from the first patient, Joe Walsh, who received the treatment. Mr. Walsh, accompanied by his wife Karen, underwent a transformative experience at Brigham and Women's Hospital, Boston, MA, where he received a monoclonal antibody via nasal administration. Intranasal foralumab, targets immune cells in the brain to mitigate inflammation, a key contributor to Alzheimer's progression.
"I've never seen anything like this, and we've tried a lot of things. So I think this is something special," stated Dr. Howard Weiner. "The reduction in brain inflammation observed in Joe Walsh represents a significant step forward in our understanding and treatment of Alzheimer's disease. We are witnessing remarkable progress with foralumab."
Karen Walsh, Joe's wife and steadfast supporter, recounted their journey from diagnosis to participation in the clinical trial. "It's been a rollercoaster," she shared. "Since Joe started the treatment, we've noticed him becoming more engaged and enjoying social activities again."
The full interview can be accessed here: https://www.tizianalifesciences.com/interview-aired-nationwide-highlighting-intranasal-foralumab-treating-moderate-alzheimers-disease/
About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]
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, which is the only fully human anti-CD3 mAb currently in clinical development, 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 more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
What is Tiziana Life Sciences' (TLSA) new treatment for Alzheimer's disease?
How does TLSA's intranasal foralumab work in treating Alzheimer's?
What results has TLSA's foralumab shown in Alzheimer's treatment?
Who is leading the research on TLSA's Alzheimer's treatment?
