Tiziana Life Sciences Announces Six-Month Qualitative Improvement in Neuroimaging in 80% of Multiple Sclerosis Patients Receiving Intranasal Foralumab
Tiziana Life Sciences (NASDAQ: TLSA) reported a 80% qualitative improvement in PET imaging for non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients receiving intranasal foralumab for at least six months. The FDA has permitted the enrollment of an additional 20 patients in the Expanded Access Program (EA), aiming to gather more data and analyze for further insights. The company also applied for FDA Orphan Drug Designation for foralumab to treat na-SPMS. This development is a significant milestone for Tiziana's immunomodulation therapies, as stated by Gabriele Cerrone, the acting CEO and founder.
- 80% of na-SPMS patients showed qualitative improvement in PET imaging.
- FDA allowance to enroll 20 more patients in the Expanded Access Program.
- Application for FDA Orphan Drug Designation for foralumab.
- Ongoing Phase 2a clinical trial for intranasal foralumab in multiple sclerosis.
- The findings are qualitative and need further quantitative analysis.
- Only 10 patients were evaluated in the initial study, which is a small sample size.
Insights
The recent announcement by Tiziana Life Sciences highlights significant progress in their treatment for Secondary Progressive Multiple Sclerosis (na-SPMS) using intranasal foralumab. The data indicates that 80% of the patients showed a qualitative improvement in neuroimaging over a six-month period. This is a notable development in the field of neurology and immunomodulation.
From a medical research perspective, it is important to note that these findings are based on qualitative improvements observed in PET imaging. While this is promising, qualitative data should ideally be supported by quantitative metrics to provide more robust evidence. The ongoing Phase 2a trial and the expanded patient cohort will be important for validating these initial findings with more substantial data. Moreover, the FDA's allowance for additional patients and the application for Orphan Drug Designation can significantly boost Tiziana's position in the MS treatment market.
For investors, it's essential to understand that while these early results are encouraging, they represent initial stages of clinical validation. The long-term success will depend on continued positive outcomes from larger, more definitive trials.
From a financial standpoint, Tiziana Life Sciences' announcement could be seen as a positive development. The qualitative improvements in neuroimaging for 80% of na-SPMS patients mark a significant milestone in their clinical trials. Such progress can potentially lead to increased investor confidence and a rise in stock value. Additionally, the application for FDA Orphan Drug Designation could provide Tiziana with various benefits, including market exclusivity and potential tax credits, which are advantageous for a biotechnology company.
However, investors should be cautious and consider the financial implications of ongoing and future clinical trials, which are often costly. The expansion of the Expanded Access Program and the ongoing Phase 2a trial will require substantial financial resources. Furthermore, achieving FDA approval is a lengthy process with no guaranteed outcomes.
In summary, while the announcement is promising, it is imperative to consider the financial commitments and risks associated with the clinical development of new therapies.
Tiziana Life Sciences' progress with intranasal foralumab for treating na-SPMS is noteworthy. The neuroimaging improvements in 80% of patients provide a competitive edge in the multiple sclerosis treatment market. Intranasal delivery is an innovative approach that could differentiate Tiziana from competitors who use traditional administration methods.
Moreover, the FDA's allowance to enroll more patients and the pursuit of Orphan Drug Designation are strategic moves to solidify their market position. The Orphan Drug Designation, if granted, could lead to market exclusivity for seven years in the U.S., providing a substantial competitive advantage.
However, market dynamics and competition must be considered. There are several players in the multiple sclerosis treatment market, with established drugs and ongoing research. Tiziana's success will depend on the efficacy and safety of foralumab as demonstrated through larger trials and its ability to navigate regulatory hurdles efficiently.
- Qualitative improvements in PET imaging seen in
80% of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access patients receiving intranasal foralumab for at least 6-months. - FDA Allowance for an additional 20 Patients to be enrolled in the intranasal foralumab Multiple Sclerosis Expanded Access Program will allow further data collection and analysis.
- Applied for FDA Orphan Drug Designation of foralumab for na-SPMS
NEW YORK, June 06, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced the qualitative results for all 10 non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients enrolled in the intermediate-size patient population Expanded Access (EA) Program receiving foralumab for at least six months.
Tarun Singhal, M.B.B.S., M.D., Director of the PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, commented, “Based on currently available data from the latest cohort of four Expanded Access patients, three out of the four subjects had findings that suggest a qualitative reduction in the microglial PET signal over a period of six months of treatment with nasal foralumab. When combined with my assessment of the first six Expanded Access patients at six months, eight of the ten suggest a qualitative reduction in microglial PET signal. Further studies are needed to confirm these findings using additional cases and quantitative approaches.”
Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences, added, “I am thrilled that
About Foralumab
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. 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, 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 further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
Investors:
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
ikoffler@lifesciadvisors.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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