New immune biomarkers uncovered with foralumab treatment

Intranasal foralumab can modulate a number of immune cell types in people with nonactive secondary progressive multiple sclerosis (SPMS), a study showed, revealing new immune biomarkers that show how the therapy exerts its effects in people with the condition. After three months of treatment, gene activity data showed that…

Foralumab wins FDA fast track designation for nonactive SPMS

Tiziana Life Sciences has received fast track designation from the U.S. Food and Drug Administration (FDA) for its intranasal foralumab to treat nonactive secondary progressive multiple sclerosis (SPMS). The FDA gives fast track status to experimental medicines that have the potential to fill unmet needs to treat serious…

Tiziana seeks sites to conduct Phase 2a trial of nasal foralumab

Tiziana Life Sciences has started to recruit clinical sites for a Phase 2a clinical trial that will investigate its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS). The announcement follows a meeting with the principal investigators of the trial at Brigham and Women’s…

EDSS Score Drop of 1 Point Seen in 2nd SPMS Patient on Foralumab

A second person with non-active secondary progressive multiple sclerosis (SPMS) treated with foralumab nasal spray in a single-patient access program is continuing to show improvements 11 months after starting the therapy, according to an update from foralumab’s developer, Tiziana Life Sciences. The patient, dubbed EA2, experienced a…

Expanded Access Program of Nasal Foralumab Enrolls 4 SPMS Patients

A group of four patients have entered a special program where they’ll gain access to foralumab nasal spray, an experimental therapy that’s being tested for non-active secondary progressive multiple sclerosis (SPMS). This is the first group of four who entered Tiziana Life Sciences’ intermediate-size expanded access program.

Second SPMS Patient Given Foralumab Continues to Improve

Six months of treatment with foralumab nasal spray led to significant functional improvements in the second patient with non-active secondary progressive multiple sclerosis (SPMS) who received treatment under a single-patient expanded access program. Findings from this patient have been generally consistent with those seen in the first non-active SPMS…

8 More SPMS Patients Cleared for Foralumab Nasal Spray Treatment

Based on findings from the first two secondary progressive multiple sclerosis (SPMS) patients given foralumab nasal spray, an experimental therapy, the U.S. Food and Drug Administration (FDA) has approved starting treatment in up to eight other patients under a special access program. Those enrolled in this intermediate-size expanded access…

Foralumab as Nasal Spray Safely, Effectively Treats 1st SPMS Patient

Six months of treatment with foralumab, an experimental nasal spray, safely and effectively improved motor and cognitive function while easing immune activation and inflammatory responses in a person with secondary progressive multiple sclerosis (SPMS), Tiziana Life Sciences, the therapy’s developer, announced. The patient — the first with MS to…

Nasal Foralumab Led to Promising Immune Effects in Phase 1 Trial

Nasally-administered foralumab, a potential treatment for neurodegenerative disorders such as progressive forms of multiple sclerosis (MS), appears safe and well-tolerated, and shows immune-modulating and anti-inflammatory effects in healthy volunteers, an updated analysis from a Phase 1 trial has found. “Nasal administration of Foralumab is a unique approach to treat…

First SPMS Patient Dosed With Foralumab Nasal Spray

Foralumab, an investigational anti-CD3 antibody that is administered via a nasal spray, has been given for the first time to a person with secondary progressive multiple sclerosis (SPMS). It was administered under an Individual Patient Expanded Access Program, which earned approval from the U.S. Food and Drug Administration in…

Potential MS Treatment Targeting CD3 Receptor Moving into Development

Tiziana Life Sciences, plc, a biotechnology company specializing in drugs to treat immunological and oncological diseases,  recently announced its intent to further develop foralumab, a fully human monoclonal antibody targeting the CD3 receptor. This approach, aiming to modulate the immune T cell response and achieve immunosuppression, is well-validated and has the potential to…