Tiziana Life Sciences Announces TV Interview with First Patient Dosed with Moderate Alzheimer’s Disease
Tiziana Life Sciences (NASDAQ: TLSA) announced a TV feature highlighting their first patient treated with intranasal foralumab for moderate Alzheimer's disease through their expanded access program. The segment showcased Joe and his wife Karen sharing their experience with the treatment.
Foralumab is a fully human anti-CD3 monoclonal antibody administered intranasally, targeting immune system dysregulation in Alzheimer's disease. The treatment aims to reduce inflammation by modulating microglial activation, a critical component in neurodegenerative diseases. The therapy works by inducing Tregs that travel to the brain to modulate neuroinflammation, an approach that has shown efficacy in animal models and MS patients.
This expanded access program allows patients without clinical trial access to receive the treatment through compassionate use. The therapy represents a potential complementary approach to existing anti-amyloid treatments, addressing neuroinflammation in Alzheimer's disease.
Tiziana Life Sciences (NASDAQ: TLSA) ha annunciato un servizio televisivo che mette in evidenza il primo paziente trattato con foralumab intranasale per l'Alzheimer moderato attraverso il loro programma di accesso ampliato. Il servizio ha mostrato Joe e sua moglie Karen che condividono la loro esperienza con il trattamento.
Il foralumab è un anticorpo monoclonale anti-CD3 completamente umano, somministrato per via intranasale, che mira a correggere la disregolazione del sistema immunitario nell'Alzheimer. Il trattamento si propone di ridurre l'infiammazione modulando l'attivazione microgliale, un componente critico nelle malattie neurodegenerative. La terapia agisce inducendo i Tregs che viaggiano verso il cervello per modulare la neuroinfiammazione, un approccio che ha dimostrato efficacia nei modelli animali e nei pazienti affetti da sclerosi multipla.
Questo programma di accesso ampliato consente ai pazienti senza accesso a studi clinici di ricevere il trattamento attraverso il suo uso compassionevole. La terapia rappresenta un potenziale approccio complementare ai trattamenti anti-amiloide esistenti, affrontando la neuroinfiammazione nella malattia di Alzheimer.
Tiziana Life Sciences (NASDAQ: TLSA) anunció una función televisiva que destaca a su primer paciente tratado con foralumab intranasal para la enfermedad de Alzheimer moderada a través de su programa de acceso ampliado. El segmento mostró a Joe y su esposa Karen compartiendo su experiencia con el tratamiento.
El foralumab es un anticuerpo monoclonal anti-CD3 completamente humano, administrado intranasalmente, que se dirige a la disfunción del sistema inmunológico en la enfermedad de Alzheimer. El tratamiento tiene como objetivo reducir la inflamación modulando la activación microglial, un componente crítico en las enfermedades neurodegenerativas. La terapia funciona induciendo Tregs que viajan al cerebro para modular la neuroinflamación, un enfoque que ha demostrado eficacia en modelos animales y en pacientes con EM.
Este programa de acceso ampliado permite a los pacientes sin acceso a ensayos clínicos recibir el tratamiento a través de su uso compasivo. La terapia representa un enfoque complementario potencial a los tratamientos anti-amiloide existentes, abordando la neuroinflamación en la enfermedad de Alzheimer.
티지아나 라이프 사이언스(Tiziana Life Sciences) (NASDAQ: TLSA)는 그들의 확장된 접근 프로그램을 통해 중증 알츠하이머 병으로 치료받은 첫 번째 환자를 조명하는 TV 방송을 발표했습니다. 이 방송에서는 조(Joe)와 그의 아내인 카렌(Karen)이 치료 경험을 공유했습니다.
포랄루맙(foralumab)은 완전 인간 anti-CD3 단클론 항체로, 알츠하이머 병의 면역 체계 이상 조절을 목표로 합니다. 이 치료법은 신경퇴행성 질환의 중요한 구성 요소인 미세아교세포의 활성을 조절하여 염증을 줄이는 것을 목표로 합니다. 이 요법은 Tregs를 유도하여 뇌로 이동, 신경 염증을 조절하는 방식으로 작용하며, 동물 모델과 다발성 경화증 환자에게서 효과를 보였습니다.
이 확장된 접근 프로그램은 임상 시험에 접근할 수 없는 환자에게 연민 기반 사용을 통해 치료를 받을 수 있게 합니다. 이 치료법은 기존의 항-아밀로이드 치료법에 대한 잠재적인 보완적 접근 방식을 제시하며, 알츠하이머 병의 신경 염증을 다루고 있습니다.
Tiziana Life Sciences (NASDAQ: TLSA) a annoncé une émission télévisée mettant en avant leur premier patient traité avec le foralumab intranasal pour la maladie d'Alzheimer modérée dans le cadre de leur programme d'accès élargi. Le segment a présenté Joe et sa femme Karen partageant leur expérience avec le traitement.
Le foralumab est un anticorps monoclonal anti-CD3 entièrement humain administré par voie intranasale, ciblant la dysrégulation du système immunitaire dans la maladie d'Alzheimer. Le traitement vise à réduire l'inflammation en modulant l'activation microgliale, un élément clé dans les maladies neurodégénératives. La thérapie fonctionne en induisant des Tregs qui se déplacent vers le cerveau pour moduler la neuroinflammation, une approche qui a montré son efficacité dans des modèles animaux et chez des patients atteints de sclérose en plaques.
Ce programme d'accès élargi permet aux patients n'ayant pas accès aux essais cliniques de recevoir le traitement par l'intermédiaire d'un usage compassionnel. La thérapie représente une approche complémentaire potentielle aux traitements anti-amyloïdes existants, en s'attaquant à la neuroinflammation dans la maladie d'Alzheimer.
Tiziana Life Sciences (NASDAQ: TLSA) kündigte ein Fernsehfeature an, das ihren ersten Patienten hervorhebt, der im Rahmen ihres erweiterten Zugangsprogramms mit intranasalem Foralumab wegen moderater Alzheimer-Erkrankung behandelt wurde. Der Beitrag zeigte Joe und seine Frau Karen, die ihre Erfahrungen mit der Behandlung teilten.
Foralumab ist ein vollständig menschlicher anti-CD3 monoklonaler Antikörper, der intranasal verabreicht wird und auf die Dysregulation des Immunsystems bei Alzheimer abzielt. Die Behandlung zielt darauf ab, Entzündungen durch die Modulation der Mikroglia-Aktivierung zu reduzieren, ein kritischer Bestandteil von neurodegenerativen Erkrankungen. Die Therapie funktioniert, indem sie Tregs induziert, die ins Gehirn reisen, um die Neuroinflammation zu modifizieren, ein Ansatz, der sich in Tiermodellen und bei MS-Patienten als wirksam erwiesen hat.
Dieses erweiterte Zugangsprogramm ermöglicht es Patienten ohne Zugang zu klinischen Studien, die Behandlung über die Mitgefühl-Nutzung zu erhalten. Die Therapie stellt einen potenziellen ergänzenden Ansatz zu bestehenden anti-Amyloid-Behandlungen dar, der die Neuroinflammation bei der Alzheimer-Krankheit adressiert.
- Novel treatment approach targeting neuroinflammation in Alzheimer's disease
- Successful implementation of expanded access program for patient treatment
- Demonstrated efficacy in animal models and MS patients
- None.
Insights
While patient testimonials can generate public interest, this TV interview represents a marketing initiative rather than material progress in foralumab's development program. The news lacks new clinical data or significant regulatory developments that would typically move biotech valuations.
However, the scientific context warrants attention: foralumab's mechanism targeting microglial activation through Treg induction represents an innovative approach distinct from traditional amyloid-targeting therapies. This is particularly relevant as the field increasingly recognizes neuroinflammation's role in Alzheimer's progression.
The expanded access program, while positive for individual patients, is still early-stage and doesn't replace the need for robust clinical trials to demonstrate efficacy. Investors should focus on upcoming clinical milestones and data readouts rather than promotional coverage.
NEW YORK, Feb. 11, 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 that its investigational drug, intranasal foralumab, was featured on a prominent News Channel. The segment highlighted the experiences of the first patient dosed in the company’s expanded access program for moderate Alzheimer’s disease.
In the segment, Joe and his Wife, Karen, shared their journey and shed light on the hope that innovative therapies like Foralumab offer for individuals battling moderate Alzheimer’s, a condition that currently has no cure and limited treatment options.
Watch the full interview here: https://youtu.be/vj6GGzbJfOk?si=lMqkFipmll8GF--o.
Dr. Howard Weiner, Co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system commented “Foralumab, administered via a novel intranasal delivery method, aims to target immune system dysregulation associated with Alzheimer's disease, potentially slowing disease progression and improving cognitive function. The recent coverage in the News underscores the growing recognition of Foralumab's promise in the field of neurodegenerative diseases.”
Foralumab’s mechanism of action involves modulating the immune system to reduce inflammation, which has been linked to neurodegeneration in Alzheimer’s. The expanded access program enables patients who do not have access to clinical trials to receive this promising treatment as part of a compassionate use initiative.
Microglial activation is increasingly recognized as a critical component of neurodegenerative diseases, including Alzheimer’s, secondary progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and Parkinson’s disease. In Alzheimer’s, this activation contributes to the pathogenesis alongside increased beta-amyloid and tau protein levels. Cognitive dysfunction in AD has been linked to both tau accumulation and microglial activation, highlighting the need for treatments beyond amyloid-targeting therapies.
Nasal foralumab, a fully human anti-CD3 monoclonal antibody, has shown efficacy in dampening microglial activation through the induction of Tregs, which travel to the brain and modulate neuroinflammation. This therapeutic effect has been validated in animal models and observed in subjects with secondary progressive MS. Nasal foralumab also holds promise as a potential adjunctive therapy that addresses a major component of AD pathogenesis not targeted by anti-amyloid therapies.
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 with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. 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).
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, 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 observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for 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, 2023, 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
A video accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/df5ac382-7310-419e-b2ef-59f1fd831999
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[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
What is the mechanism of action of Tiziana's (TLSA) intranasal foralumab in Alzheimer's treatment?
How is TLSA's foralumab different from traditional Alzheimer's treatments?
What is the current status of TLSA's expanded access program for Alzheimer's?
What conditions besides Alzheimer's could TLSA's foralumab potentially treat?
