RE: WHAT IS HAPPENING WITH ACCUSTEM21 Oct 2024 12:37
Https://ir.tizianalifesciences.com/node/11551/html
Buried at the bottom:
'In May:
Tiziana announced it had submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). This request would make foralumab the first therapy for na-SPMS to receive Orphan Drug Designation. Our request is supported by clinical and non-clinical evidence of foralumab’s effectiveness in na-SPMS. The prevalence estimates, in part, are supported from the Brigham & Women’s Hospital, Boston, Massachusetts, longitudinal study, the CLIMB data of which allowed the estimate of na-SPMS in the population. The FDA have requested further information from Tiziana with regards to this request.'
From the start:
'NEW YORK, October 18, 2024 – 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 interim financial results for the six months ended June 30, 2024, and provided a corporate update on its lead programs in development.
Gabriele Cerrone, Executive Chairman, and founder of Tiziana, commented, “The past six months have been defined by meaningful strides in advancing our portfolio of innovative therapeutic candidates. In particular, we are encouraged by the progress in our lead programs targeting neurodegenerative and autoimmune diseases. Our lead asset, foralumab, continues to show significant promise in our expanded access program for multiple sclerosis (MS), which has reaffirmed our confidence in its potential to revolutionize treatments in this area.
We have also achieved a key milestone in our intranasal formulation of foralumab, the start of our Phase 2 study for non-active (non-relapsing) Secondary Progressive Multiple Sclerosis. The positive early-stage clinical data from our expanded access Multiple Sclerosis studies have been very encouraging, indicating the potential of our novel approach to delivering therapies with increased efficacy and fewer side effects compared to traditional treatments. As we continue to evaluate these outcomes, we are optimistic that this can offer patients a much-needed, more tolerable option for managing chronic conditions.
We have been awarded Fast Track designation by the FDA, which is a significant milestone, providing an expedited review process and increased interaction with the FDA. This designation is intended to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need.”
First Half 2024 Developments Related to Foralumab
In January:
Tiziana announced the filing of a new patent application relating to composition and methods for combining GLP-1ra and foralumab, a fully human anti-CD3 antibody, to achieve further reductions in systemic and vascular inflammation associated