Tiziana Life Sciences Announces Dosing of Additional Patients in Multiple Sclerosis Expanded Access Program
Tiziana Life Sciences (TLSA) has announced the dosing of four additional patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) program for non-active secondary progressive multiple sclerosis (na-SPMS). The program now includes 14 patients total, with the first 10 patients showing either improvement or disease stability within 6 months of treatment initiation.
The expanded access program utilizes intranasal foralumab, the company's lead development candidate and a fully human, anti-CD3 monoclonal antibody. This program specifically targets patients who don't qualify for the ongoing Phase 2a clinical trial (NCT06292923), providing access to this investigational therapy for those who might not otherwise receive it.
Tiziana Life Sciences (TLSA) ha annunciato la somministrazione a quattro pazienti aggiuntivi nel suo programma di Accesso Espanso per la Popolazione di Pazienti di Dimensioni Intermedie (ISPPEA) per la sclerosi multipla secondaria progressiva non attiva (na-SPMS). Il programma ora include un totale di 14 pazienti, con i primi 10 pazienti che mostrano miglioramenti o stabilità della malattia entro 6 mesi dall'inizio del trattamento.
Il programma di accesso espanso utilizza foralumab intranasale, il principale candidato allo sviluppo dell'azienda e un anticorpo monoclonale anti-CD3 completamente umano. Questo programma è specificamente rivolto ai pazienti che non soddisfano i requisiti per il trial clinico di Fase 2a in corso (NCT06292923), fornendo accesso a questa terapia sperimentale per coloro che altrimenti potrebbero non riceverla.
Tiziana Life Sciences (TLSA) ha anunciado la dosificación de cuatro pacientes adicionales en su programa de Acceso Expandido para la Población de Pacientes de Tamaño Intermedio (ISPPEA) para la esclerosis múltiple secundaria progresiva no activa (na-SPMS). El programa ahora incluye un total de 14 pacientes, con los primeros 10 pacientes mostrando mejoría o estabilidad de la enfermedad dentro de los 6 meses posteriores al inicio del tratamiento.
El programa de acceso expandido utiliza foralumab intranasal, el principal candidato en desarrollo de la empresa y un anticuerpo monoclonal anti-CD3 completamente humano. Este programa está dirigido específicamente a pacientes que no califican para el ensayo clínico de Fase 2a en curso (NCT06292923), proporcionando acceso a esta terapia experimental para aquellos que de otro modo no podrían recibirla.
티지안나 라이프 사이언스 (TLSA)는 비활성 2차 진행형 다발성 경화증(na-SPMS)에 대한 중간 크기 환자 모집단 확대 접근(ISPPEA) 프로그램에서 네 명의 추가 환자에 대한 투여를 발표했습니다. 이 프로그램에는 총 14명의 환자가 포함되며, 처음 10명의 환자는 치료 시작 후 6개월 이내에 개선 또는 질병 안정성을 보였습니다.
확대 접근 프로그램은 비강 포랄루맙을 활용하며, 이는 회사의 주요 개발 후보이자 완전 인간 항-CD3 단클론 항체입니다. 이 프로그램은 현재 진행 중인 2a상 임상 시험(NCT06292923)에 적합하지 않은 환자들을 대상으로 하여, 그렇지 않으면 이 실험적 치료를 받을 수 없는 환자들에게 접근을 제공합니다.
Tiziana Life Sciences (TLSA) a annoncé la dose de quatre patients supplémentaires dans son programme d'accès élargi pour la population de patients de taille intermédiaire (ISPPEA) pour la sclérose en plaques secondaire progressive non active (na-SPMS). Le programme comprend désormais un total de 14 patients, dont les 10 premiers montrent une amélioration ou une stabilité de la maladie dans les 6 mois suivant le début du traitement.
Le programme d'accès élargi utilise foralumab intranasal, le principal candidat au développement de l'entreprise et un anticorps monoclonal anti-CD3 entièrement humain. Ce programme s'adresse spécifiquement aux patients qui ne répondent pas aux critères de l'essai clinique de phase 2a en cours (NCT06292923), offrant ainsi un accès à cette thérapie expérimentale à ceux qui ne pourraient pas autrement en bénéficier.
Tiziana Life Sciences (TLSA) hat die Dosierung von vier zusätzlichen Patienten in seinem Programm für den erweiterten Zugang zur Patientengruppe mittlerer Größe (ISPPEA) für nicht aktive sekundäre progressive Multiple Sklerose (na-SPMS) bekannt gegeben. Das Programm umfasst nun insgesamt 14 Patienten, wobei die ersten 10 Patienten innerhalb von 6 Monaten nach Behandlungsbeginn eine Verbesserung oder Stabilität der Krankheit zeigten.
Das erweiterte Zugangsprogramm nutzt intranasales Foralumab, den Hauptentwicklungskandidaten des Unternehmens und einen vollständig humanen, anti-CD3 monoklonalen Antikörper. Dieses Programm richtet sich speziell an Patienten, die nicht für die laufende klinische Studie der Phase 2a (NCT06292923) qualifiziert sind, und bietet diesen Patienten Zugang zu dieser experimentellen Therapie, die sie ansonsten möglicherweise nicht erhalten würden.
- First 10 patients showed improvement or disease stability within 6 months of treatment
- Successfully expanded patient enrollment from 10 to 14 in the ISPPEA program
- None.
Insights
The expansion of Tiziana's expanded access program for na-SPMS represents a significant milestone with both clinical and strategic implications. The enrollment of 14 patients, with positive preliminary results in the first 10 patients, provides encouraging signals for the company's intranasal foralumab program. The reported improvement or disease stability in all initial patients within 6 months is particularly noteworthy, as na-SPMS typically shows continuous deterioration with treatment options.
The intranasal delivery mechanism of foralumab is a key differentiator. Traditional monoclonal antibody treatments often require intravenous or subcutaneous administration, which can impact patient compliance and treatment costs. The intranasal route could potentially offer better central nervous system penetration while maintaining a favorable safety profile.
From a development perspective, the expanded access program serves multiple strategic purposes:
- It provides additional safety and efficacy data outside the formal clinical trial setting
- It maintains treatment access for patients who don't qualify for the Phase 2a trial, potentially building advocacy within the patient community
- It generates real-world evidence that could support future regulatory submissions
The parallel running of both the expanded access program and the Phase 2a trial (NCT06292923) demonstrates efficient resource utilization and could accelerate the overall development timeline. This dual-track approach allows Tiziana to gather complementary datasets while potentially expanding their understanding of foralumab's therapeutic potential across different patient populations.
NEW YORK, Feb. 18, 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 the dosing of an additional four patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) for patients with non-active secondary progressive multiple sclerosis (na-SPMS) who do not qualify for the ongoing Phase 2a study (NCT06292923). To date, 14 patients have now been enrolled in the expanded access program. The first 10 patients have all shown either an improvement or stability of disease within 6 months of starting treatment.
The na-SPMS expanded access program allows patients who do not meet the inclusion criteria for the ongoing Phase 2a clinical trial to receive treatment with Tiziana’s investigational therapy, intranasal foralumab. This initiative aims to provide potential therapeutic benefits to individuals who may not otherwise have access to these promising treatments.
Ivor Elrifi, CEO of Tiziana Life Sciences, commented, “We are pleased to reach this milestone of enrolling 14 patients in our na-SPMS expanded access program. This underscores our commitment to addressing the unmet medical needs of patients with na-SPMS, particularly those who are not eligible for our ongoing Phase 2a clinical trial. We remain dedicated to advancing our therapies and look forward to further evaluating their potential through both expanded access and clinical trials.”
Tiziana Life Sciences continues to advance its comprehensive research and development efforts to bring forward novel treatments that have the potential to transform the lives of patients with neuroinflammatory disorders including na-SPMS, Alzheimer’s Disease, and ALS.
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
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
What results has Tiziana Life Sciences (TLSA) reported from its na-SPMS expanded access program?
How many patients are currently enrolled in TLSA's expanded access program for multiple sclerosis?
What is the purpose of TLSA's expanded access program for multiple sclerosis?
What is the main drug candidate being tested in TLSA's multiple sclerosis program?
