Tiziana Life Sciences expands Phase 2 trial for intranasal foralumab in non-active secondary progressive multiple sclerosis across prominent Northeast institutions.
Quiver AI Summary
Tiziana Life Sciences, Ltd. has announced the expansion of its Phase 2 clinical trial for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, aimed at treating non-active secondary progressive multiple sclerosis (SPMS). The trial will be conducted at prestigious institutions in the Northeast U.S., including Yale, Johns Hopkins, and Cornell, among others, allowing for standardized PET scans at a centralized location to ensure data consistency. This initiative highlights the company's commitment to addressing the unmet therapeutic needs in SPMS, where no FDA-approved treatments currently exist. Foralumab is designed to modulate the immune system to reduce inflammation without systemic suppression. The trial aims to generate data to support future regulatory strategies, building on initial positive results in an expanded access program. Tiziana, focused on innovative drug delivery methods, hopes for further advancements in neurodegenerative disease treatments through its approach.
Potential Positives
- Expansion of Phase 2 clinical trial for intranasal foralumab demonstrates Tiziana's commitment to addressing a significant unmet medical need in non-active secondary progressive multiple sclerosis (SPMS).
- Collaboration with prestigious institutions like Yale, Johns Hopkins, and Cornell enhances the credibility and reach of the clinical trial, attracting top-tier expertise and resources.
- The selection of a single imaging site for PET scans minimizes variability, which is crucial for generating robust, high-quality data to support future regulatory strategies.
- Positive initial results from the Expanded Access Program, with all dosed patients showing either improvement or stability of disease, indicate potential efficacy of intranasal foralumab.
Potential Negatives
- Expansion of the Phase 2 trial indicates ongoing challenges in achieving FDA approval for intranasal foralumab, as the treatment must demonstrate significant efficacy in a population with no existing therapeutic options.
- The reliance on elevated clinical trial enrollment in high-caliber institutions could suggest previous challenges or insufficient patient recruitment in earlier phases.
- Despite promising data in the expanded access program, the interim findings involve a limited sample size (10 patients), raising concerns about the robustness of reported improvements or stability of disease.
FAQ
What is Tiziana Life Sciences' recent announcement?
Tiziana announced the expansion of its Phase 2 clinical trial for intranasal foralumab targeting non-active secondary progressive multiple sclerosis.
Where are the trial sites located?
The trial sites include notable institutions like Yale University, Johns Hopkins University, and Cornell University in the Northeast USA.
What is intranasal foralumab?
Intranasal foralumab is a fully human anti-CD3 monoclonal antibody aimed at stimulating T regulatory cells to modulate inflammation.
Why is there a need for this study?
There are currently no FDA-approved treatments for non-active secondary progressive multiple sclerosis, highlighting a significant unmet medical need.
How can I find more information about the trial?
For details about the trial, including enrollment criteria, visit the clinicaltrials.gov link: https://clinicaltrials.gov/study/NCT06292923.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
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