Tiziana Life Sciences Announces Positive Clinical Results in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) Following Three Months of Dosing with Intranasal Foralumab
- A second patient also showed clinical improvements in the Positron Emission Tomography (PET) imaging analysis, neurologic exam, and in the Timed 25-Foot Walk test, following three months of treatment. These findings are consistent with the results obtained from the first patient following 3-months of treatment, as previously announced on
March 10, 2022.
- The PET imaging data from the second SPMS patient was conducted at a different hospital, yet the data confirms the previously reported findings of the PET imaging of the first patient, which was conducted at the
Brigham and Women's Hospital(BWH) in Boston.
- Based on the safety data, clinical evaluation, and confirmatory PET imaging data from these two patients, the FDA has allowed enrollment of an additional eight eligible SPMS patients to receive the same intranasal Foralumab therapy under an Intermediate Size Expanded Access Program.
The second patient, a young male in his 40s, was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation of disability. Following completion of three months of treatment with intranasal foralumab (50 mcg; three times a week for two weeks, followed by one week off treatment), the patient showed improvement as measured by PET imaging, to assess inhibition of microglial activation, and by neurologic examination. Approximately 10-30% reduction in PET signal was seen across brain regions (including cortex, thalamus, white matter, and cerebellum) in the second SPMS patient, which is comparable to the PET changes seen in the first SPMS patient following three months of treatment with intranasal foralumab. Clinically, the Timed 25-Foot Walk test and neurologic exam were also improved. Both the first and the second patient are continuing with the treatment and are in their 13th and 4th months of treatment, respectively.
The favorable safety, tolerability, and clinical responses from the first two SPMS patients were submitted to the
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn's disease. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy. Once a day treatment for 10 consecutive days with intranasal foralumab was not only well tolerated but it also produced strong clinical responses in COVID-19 patients. Based on these studies, the intranasal and oral administration of foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs.
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. 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.
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Source: Tiziana Life Sciences Ltd.