Tiziana Life Sciences Expands Phase 2 Clinical Trial for Non-Active Secondary Progressive Multiple Sclerosis to Additional Prestigious U.S. Medical Centers
Tiziana Life Sciences (NASDAQ: TLSA) has expanded its Phase 2 clinical trial for intranasal foralumab in non-active secondary progressive multiple sclerosis (SPMS) to include prestigious medical centers across the Northeast United States. The trial now encompasses Yale University, Johns Hopkins University, Cornell University, University at Buffalo, University of Massachusetts, and Thomas Jefferson University.
The strategic selection of Northeast locations enables all trial participants to receive PET scans at a single imaging site at Invicro in New Haven, Connecticut, minimizing scan variability. This expansion is particularly significant as non-active SPMS currently has no FDA-approved therapeutic options. The company's intranasal foralumab offers a unique approach by targeting inflammation and modulating the immune system without systemic immune suppression.
Tiziana Life Sciences (NASDAQ: TLSA) ha ampliato la sua sperimentazione clinica di fase 2 per il foralumab intranasale nella sclerosi multipla secondaria progressiva non attiva (SPMS) per includere prestigiosi centri medici nel Nordest degli Stati Uniti. La sperimentazione ora comprende l'Università di Yale, l'Università Johns Hopkins, l'Università di Cornell, l'Università di Buffalo, l'Università del Massachusetts e l'Università Thomas Jefferson.
La selezione strategica delle sedi nel Nordest consente a tutti i partecipanti allo studio di ricevere scansioni PET in un'unica sede di imaging presso Invicro a New Haven, Connecticut, riducendo al minimo la variabilità delle scansioni. Questa espansione è particolarmente significativa poiché la SPMS non attiva attualmente non ha opzioni terapeutiche approvate dalla FDA. Il foralumab intranasale dell'azienda offre un approccio unico mirato a ridurre l'infiammazione e a modulare il sistema immunitario senza soppressione immunitaria sistemica.
Tiziana Life Sciences (NASDAQ: TLSA) ha ampliado su ensayo clínico de fase 2 para foralumab intranasal en esclerosis múltiple secundaria progresiva no activa (SPMS) para incluir prestigiosos centros médicos en el noreste de los Estados Unidos. El ensayo ahora incluye la Universidad de Yale, la Universidad Johns Hopkins, la Universidad de Cornell, la Universidad de Buffalo, la Universidad de Massachusetts y la Universidad Thomas Jefferson.
La selección estratégica de ubicaciones en el noreste permite que todos los participantes del ensayo reciban exploraciones PET en un único sitio de imagen en Invicro en New Haven, Connecticut, minimizando la variabilidad en las exploraciones. Esta expansión es particularmente significativa ya que la SPMS no activa actualmente no tiene opciones terapéuticas aprobadas por la FDA. El foralumab intranasal de la compañía ofrece un enfoque único al atacar la inflamación y modular el sistema inmunológico sin suprimir inmunológicamente de manera sistémica.
티치아나 라이프 사이언스(Tiziana Life Sciences, NASDAQ: TLSA)는 비활동성 이차 진행형 다발성 경화증(SPMS)을 위한 비강 포랄루맙의 2상 임상 시험을 미국 북동부의 권위 있는 의료 센터들이 포함되도록 확대하였습니다. 이제 이 시험은 예일 대학교, 존스 홉킨스 대학교, 코넬 대학교, 버팔로 대학교, 매사추세츠 대학교, 토머스 제퍼슨 대학교를 포함합니다.
북동부 지역의 전략적 선택은 모든 시험 참가자가 코네티컷주 뉴헤이븐에 있는 인비크로(Invicro)에서 단일 영상 촬영 사이트에서 PET 스캔을 받을 수 있도록 하여 스캔 변동성을 최소화합니다. 이 확장은 현재 비활동성 SPMS에 대해 FDA 승인 치료 옵션이 전혀 없기 때문에 특히 의미가 있습니다. 회사의 비강 포랄루맙은 염증을 타겟으로 하고 면역 시스템을 조절하는 독특한 접근법을 제공하면서도 전신 면역 억제를 하지 않습니다.
Tiziana Life Sciences (NASDAQ: TLSA) a élargi son essai clinique de phase 2 sur le foralumab intranasal dans la sclérose en plaques secondaire progressive non active (SPMS) pour inclure des centres médicaux prestigieux dans le nord-est des États-Unis. L'essai comprend désormais l'Université de Yale, l'Université Johns Hopkins, l'Université de Cornell, l'Université de Buffalo, l'Université du Massachusetts et l'Université Thomas Jefferson.
Le choix stratégique des emplacements dans le nord-est permet à tous les participants à l'étude de recevoir des scans PET à un seul site d'imagerie chez Invicro à New Haven, Connecticut, ce qui minimise la variabilité des scannes. Cette expansion est particulièrement significative car la SPMS non active n'a actuellement aucune option thérapeutique approuvée par la FDA. Le foralumab intranasal de l'entreprise offre une approche unique en ciblant l'inflammation et en mod modulant le système immunitaire sans suppression immunitaire systémique.
Tiziana Life Sciences (NASDAQ: TLSA) hat seine Phase-2-Studie zu intranasalem Foralumab bei nicht aktiver sekundärer progredienter Multipler Sklerose (SPMS) auf renommierte medizinische Zentren im Nordosten der Vereinigten Staaten ausgeweitet. Die Studie umfasst nun die Yale University, die Johns Hopkins University, die Cornell University, die University at Buffalo, die University of Massachusetts und die Thomas Jefferson University.
Die strategische Auswahl der Standorte im Nordosten ermöglicht es allen Teilnehmern der Studie, PET-Scans an einem einzigen Bildgebungsstandort bei Invicro in New Haven, Connecticut, zu erhalten und minimiert so die Variabilität der Scans. Diese Erweiterung ist besonders bedeutsam, da es derzeit für die nicht aktive SPMS keine von der FDA zugelassenen therapeutischen Optionen gibt. Das intranasale Foralumab des Unternehmens bietet einen einzigartigen Ansatz zur Behandlung von Entzündungen und zur Modulation des Immunsystems, ohne eine systemische Immunsuppression zu verursachen.
- Expansion to six prestigious medical research institutions enhances trial credibility
- Addresses an unmet medical need with no current FDA-approved treatments
- Strategic site selection minimizes PET scan variability through centralized imaging
- None.
Insights
The expansion of Tiziana's Phase 2 clinical trial for intranasal foralumab to multiple prestigious medical centers represents a significant development in addressing non-active SPMS, an area with substantial unmet medical needs. The strategic selection of Northeast-based trial sites, centered around a single PET scanning facility at Invicro, demonstrates methodological rigor by minimizing imaging variability - a important factor in neurology trials.
The trial's focus on non-active SPMS is particularly noteworthy as there are currently no FDA-approved treatments for this condition. Foralumab's intranasal delivery mechanism offers a novel approach by targeting inflammation locally without causing systemic immunosuppression, potentially providing a better safety profile compared to traditional MS treatments.
The collaboration with six prestigious academic medical centers significantly enhances the trial's credibility and increases the likelihood of high-quality data generation. This multi-center approach could accelerate patient recruitment and strengthen the statistical power of the study results.
For a small-cap biotech company with a market cap of
The focus on non-active SPMS represents a substantial market opportunity, considering the lack of approved treatments. Success in this indication could translate to significant market share in an underserved segment of MS patients. The centralized imaging approach at Invicro shows careful trial design that could strengthen the eventual data package for regulatory submission.
However, investors should note that Phase 2 trials still carry significant development risks and the company's small market cap suggests financial resources. The trial's outcome will be important for Tiziana's future valuation and potential partnerships or funding opportunities.
NEW YORK, Dec. 04, 2024 (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 expansion of its Phase 2 clinical trial evaluating intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS). The trial sites include esteemed institutions across the Northeast of the United States.
Additional trial sites include:
- Yale University
- Johns Hopkins University
- Cornell University
- University at Buffalo (SUNY)
- University of Massachusetts (UMass)
- Thomas Jefferson University
These universities represent leaders in medical research and neurology, with a history of pioneering studies in multiple sclerosis. Their inclusion enhances the trial's reach and brings together top-tier expertise with innovative facilities to evaluate Tiziana’s promising approach to addressing SPMS. The rationale in selecting sites in the Northeast is to have all trial participants receive their PET scans at a single imaging site at Invicro, located at New Haven, Connecticut to minimize the variability of the PET scans.
Non-active SPMS remains a significant unmet need within the multiple sclerosis community, with no FDA approved therapeutic options available. Tiziana's intranasal foralumab offers a unique approach, targeting inflammation and modulating the immune system without systemic immune suppression.
“We are honored to collaborate with these prestigious institutions as we further expand our clinical trial,” said Ivor Elrifi, CEO of Tiziana Life Sciences. “This milestone demonstrates our dedication to advancing innovative treatments for patients living with SPMS and underscores the potential of our platform to address complex neurodegenerative diseases.”
The Phase 2 trial aims to generate robust, high-quality data to support Tiziana’s regulatory strategy. For further information on the trial, including enrollment criteria and site details, visit https://clinicaltrials.gov/study/NCT06292923.
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. Activated T cells play an important 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. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]
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). 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.
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, 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
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 the purpose of Tiziana Life Sciences (TLSA) Phase 2 clinical trial expansion?
Which medical centers are included in TLSA's expanded Phase 2 trial?
How does Tiziana's (TLSA) intranasal foralumab treatment work for SPMS?
